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    Sanofi pens $395M China pact for Arrowhead Metabolic med

    02 Aug 2025

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    Sanofi`s Avapro Receives Approval in US

    01 Aug 2025

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    Q4 Sales Up 10.3%, EPS Beats FY24, Rebound Expected in 2025

    31 Jul 2025

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    Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Sanofi Genzyme is the specialty care global business unit of Sanofi, a leading pharmaceutical company. It focuses on developing and delivering innovative treatments for rare diseases, blood disorders, neurology, immunology, and oncology. Committed to setting new industry benchmarks, Sanofi Genzyme leverages scientific expertise, cutting-edge technologies, and a patient-centric approach to drive research, development, and manufacturing of breakthrough therapies. As a pioneer in biotechnology and precision medicine, the company remains at the forefront of medical innovation.

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    J&J’s Intra‑Cellular buyout, BMS’ oncology gambit, Sanofi’s Blueprint acquisition drive mega deals in H1 2025

    J&J’s Intra‑Cellular buyout, BMS’ oncology gambit, Sanofi’s Blueprint acquisition drive mega deals in H1 2025

    The pharmaceutical industry has witnessed a wave of mergers, acquisitions, and strategic partnerships so far in the first half (H1) of 2025, with deal values exceeding US$ 170 billion.PharmaCompass’ data shows oncology alone accounted for nearly US$ 47 billion in deal value, followed by US$ 18 billion each in immunology and psychiatry, US$ 17 billion in nutrition/weight loss and US$ 7 billion in neurology.Pharma majors such as Johnson & Johnson and Bristol Myers Squibb led with two deals worth over US$ 10 billion each. Sanofi executed a series of deals in the immunology and neuro-inflammation space. And Eli Lilly stood out for its aggressive dealmaking, which spanned oncology, pain, RNA therapies, and AI-driven oligonucleotides. In all, it signed seven deals worth over US$ 1 billion each. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available)H1 records several mega deals as J&J buys Intra-Cellular, BMS ties up with BioNTech, Sanofi acquires BlueprintJohnson & Johnson dominated headlines with its US$ 14.6 billion acquisition of Intra-Cellular Therapies in January 2025. This marks the largest biopharma deal since Novo Nordisk’s US$ 16.5 billion acquisition of Catalent in February 2024. This acquisition positions J&J as a formidable player in the neuroscience space. Bristol Myers Squibb entered into a US$ 11.1 billion partnership with BioNTech. The deal structure — US$ 3.5 billion in unconditional payments and up to US$ 7.6 billion in milestone payments — demonstrates BMS’ confidence in BNT327, a next-generation bispecific antibody in phase 3 trials for treating extensive stage small cell lung cancer and non-small cell lung cancer.Sanofi acquired Blueprint Medicines for US$ 9.5 billion in order to enhance its rare disease portfolio. The French drugmaker is also creating a comprehensive immunology portfolio. The company signed a US$ 1.9 billion deal for Dren Bio’s DR-0201 bispecific antibody for autoimmune diseases. Sanofi also acquired Vigil Neuroscience for US$ 470 million for its phase 2-ready Alzheimer’s disease candidate. Additionally, the drugmaker secured a US$ 1.84 billion global license agreement with Earendil Labs for two next-generation bispecific antibodies.Pfizer’s US$ 6.05 billion partnership with 3SBio provides it global licensing rights (excluding China) for SSGJ-707, a bispecific antibody currently undergoing multiple clinical trials in China for non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available) Obesity gold rush sees Roche, AbbVie, Sciwind ink deals; Novo pledges over US$ 5 bn across three dealsThe obesity therapeutics market has triggered intense competition among pharmaceutical giants. Roche’s US$ 5.3 billion partnership with Zealand Pharma is focused on petrelintide, an amylin analog designed to preserve lean mass better than existing GLP-1-based treatments. The collaboration combines petrelintide with Roche’s dual GLP-1/GIP receptor agonist CT-388, creating a differentiated obesity treatment.Market leader Novo Nordisk has promised over US$ 5 billion across three major obesity deals in 2025. The US$ 2.2 billion Septerna collaboration targets oral small molecule medicines for obesity and cardiometabolic diseases.Novo signed a separate US$ 2 billion agreement with China’s United Biotechnology for UBT251, a triple agonist for GLP-1, GIP, and glucagon receptors in phase 2 clinical development for obesity, type 2 diabetes, and other diseases. The company’s third major deal, a US$ 1 billion partnership with Lexicon Pharmaceuticals, provides it access to LX9851, a molecule in preclinical development for obesity and associated metabolic disorders.Sciwind Biosciences secured a US$ 2.5 billion global licensing and collaboration agreement with Verdiva Bio Limited for the global development and commercialization of a portfolio of metabolic diseases therapies. AbbVie entered the amylin arena through its US$ 2.2 billion Gubra partnership for GUB014295, a candidate in phase 1 trials for treating obesity. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available) Molecular glue degraders draw investments; Lilly signs seven deals over US$ 1 billion eachMolecular glue degraders have emerged as a transformative therapeutic modality, attracting significant investment across multiple partnerships. AbbVie’s US$ 1.64 billion collaboration with Neomorph leverages the biotech’s leading molecular glue discovery platform for oncology and immunology applications.Genentech’s potential US$ 2.1 billion partnership with Orionis Biosciences focuses on small-molecule monovalent glue medicines for novel and challenging oncology targets. This is the second partnership between the two companies, following their initial 2023 collaboration.Eli Lilly has collaborated with Magnet Biomedicine, utilizing Magnet’s TrueGlue discovery platform for oncology applications. The deal could be worth up to US$ 1.3 billion.Eli Lilly has emerged as one of 2025’s most active dealmakers, with approximately seven deals exceeding US$ 1 billion each. The company’s US$ 2.5 billion Scorpion Therapeutics acquisition provides access to STX-478, an experimental oral therapy in early-stage trials for breast cancer and advanced solid tumors, potentially addressing 30 to 40 percent of hormone-positive breast cancer patients.On June 17, Lilly announced the acquisition of gene-editing startup Verve Therapeutics for US$ 1.3 billion. Lilly’s US$ 1 billion SiteOne acquisition announced in May brings STC-004, a phase 2-ready non-opioid chronic pain treatment to its pipeline. Other partnerships announced by Lilly include a US$ 1.4 billion capsid licensing deal with Sangamo for central nervous system disease genomic medicines and a US$ 1.3 billion collaboration with South Korean company Rznomics for RNA-based hearing loss treatments. Lilly has also strengthened its oligonucleotide pipeline through a potential US$ 1 billion collaboration with Creyon Bio for AI-designed oligonucleotide therapies targeting RNA. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available) Merck KGaA acquires SpringWorks for US$ 3.9 bn; Novartis buys out Anthos for US$ 3.1 bnAstraZeneca signed a US$ 5.3 billion AI-led research agreement with China’s CSPC Pharmaceuticals Group to advance the discovery of novel oral candidates for immunological diseases. Merck KGaA acquired SpringWorks for US$ 3.9 billion in April, which gave it access to two FDA-approved therapies — Ogsiveo (nirogacestat), the first and only approved therapy for adult patients with progressing desmoid tumors requiring systemic treatment, and Gomekli (mirdametinib), the first and only FDA-approved therapy for adults and children with neurofibromatosis type 1-associated plexiform neurofibromas.Novartis’ US$ 3.1 billion Anthos Therapeutics acquisition centered around abelacimab, a potential first-in-class monoclonal antibody currently in three phase 3 studies for stroke and systemic embolism prevention in atrial fibrillation patients.GSK’s US$ 2 billion acquisition of Boston Pharmaceuticals’ efimosfermin targets steatotic liver disease (fatty liver disease). The medicine is also in clinical development for MASH treatment. GSK’s second major deal involved the US$ 1.15 billion acquisition of US biotech IDRx, strengthening its gastrointestinal cancer portfolio.The pharma industry also drew some private equity interest as Bain Capital acquired Japan’s Mitsubishi Tanabe Pharma from Mitsubishi Chemical Group for US$ 3.3 billion. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available) Our viewDespite an uncertain geopolitical environment, the year has seen a surge in M&As and dealmaking in the first half of 2025. However, a sizable chunk of the acquisitions were bolt-on transactions, indicating that companies are not ready to take on risks, and are buying out smaller players who strategically fit into their operations. Going forward, there are indications that M&A activity will stay strong throughout 2025. 
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    19 Jun 2025
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    US drug shortages reduce 16% YoY in Q1 2025; CNS drugs, antimicrobials face highest scarcities

    US drug shortages reduce 16% YoY in Q1 2025; CNS drugs, antimicrobials face highest scarcities

    The pharmaceutical industry in the United States continued to grapple with drug shortages during the first quarter (Q1) of 2025. According to the American Society of Health‑System Pharmacists (ASHP), the total number of active shortages stood at 270 as of March 31, 2025 — only slightly below the 277 reported in September 2024, but down 16.4 percent from an all‑time high of 323 reported in Q1 2024.These numbers imply that while dramatic surges in drug shortages may have subsided, underlying vulnerabilities in manufacturing, supply chains, and raw‑material sourcing continue to frustrate efforts towards a durable resolution.A deeper analysis of these drug scarcities reveals that 41 percent of the 270 active shortages first emerged in 2022 or earlier. This implies that many of the current disruptions have become chronic in nature and are exerting pressure on pharmacy operations. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available)CNS drugs dominate with 49 meds in short supply; antimicrobials face shortage of 39 drugsClass‑specific analysis reveals that central nervous system (CNS) agents remained the most disrupted category, with 49 distinct CNS drugs having faced scarcities during Q1. This group spans anxiolytics (anti-anxiety drugs) such as clonazepam and flurazepam, sedatives like lorazepam and midazolam, and stimulants such as methylphenidate and lisdexamfetamine. These shortages pose two challenges — controlling seizures and managing sedation in acute care settings. After CNS agents, antimicrobials was the second‑largest category, with shortages affecting 39 drugs. Key antibacterial and anti-fungal agents such as cefotaxime sodium powder for injection, clindamycin phosphate, rifampin, and metronidazole find themselves on ASHP’s active‑shortage roster, threatening both routine hospital protocols and emergency sepsis management.Fluids and electrolytes occupied the third spot, with 29 items facing shortage in Q1 2025. Hormone agents, including insulin analogs, ranked fourth with 24 drugs in short supply.Chemotherapy medications rounded out the top five categories, with 23 antineoplastic agents (a broad class of medications used to treat cancer) flagged as actively constrained in Q1 2025. Notable shortages included azacitidine, carboplatin, methotrexate, and streptozocin. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available) US faces 26 new shortages; Pharmacopeia list warns of 100 vulnerable medicationsThe first quarter saw the emergence of 26 new shortage declarations, emphasizing that even drugs previously deemed reliably sourced can fall into scarcity. The US has been facing a shortage of attention deficit hyperactivity disorder (ADHD) drugs since 2022. The new shortages included ADHD transdermal patch methylphenidate, peginterferon alfa‑2a (Pegasys) used in chronic hepatitis B and C, and bacitracin ophthalmic ointment.The fragility of the pharmaceutical supply chains has been particularly evident in the aftermath of natural disasters. Hurricane Helene’s flooding at Baxter’s Marion, North Carolina, facility deeply affected IV‑solution supply lines. Baxter supplies roughly 60 percent of the US’ IV fluids and the ASHP report listed “hurricane” as the reason behind nine percent of drug shortages, as of January 2025.Regulatory and policy interventions continue to evolve. The US Pharmacopeia’s inaugural Vulnerable Medicines List, launched in 2025, identifies 100 drugs at the highest risk of future shortages, with a particular focus on injectables (comprising 71 percent of the list) and essential hospital care.Antibiotics, medications for pain management and oncology are the other drugs on the list. Although 61 percent of these vulnerable medicines were not in active shortage at the time of listing, their inclusion is intended to galvanize manufacturers and purchasing organizations to bolster inventories.Meanwhile, the Government Accountability Office in the US has called on the Department of Health and Human Services (HHS) to establish a formal coordination mechanism, warning that elimination of the HHS supply‑chain coordinator role in May 2025 risks fragmenting federal response efforts. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available) Global shortages mirror US patterns; Europe launches monitoring platform Globally, we notice comparable trends. For instance, Europe has rolled out the European Shortages Monitoring Platform (ESMP) this year in order to centralize shortage reporting across member states. Critical‑medicine shortages in the EU — in areas such as oncology, ADHD, and critical care analgesics — mirror US patterns. The European Medicines Agency’s shortage list currently holds 37 human drugs.According to Health Canada’s May 12, 2025 update, its Tier 3 list had 18 drug shortages that are considered to have the greatest impact on Canada’s drug supply and health‑care system. Tier 3 designation is based on medical necessity and minimal availability of alternatives.In hematology and oncology, scarcity of essential drugs like Oncaspar for acute lymphoblastic leukemia, idarubicin and lomustine for leukemias and brain tumors, anagrelide for thrombocythemia, and preservative‑free methotrexate for various malignancies underscore the impact these drug shortages can have on treatment. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available) Our viewThe global pharma supply chain is dealing with a fresh wave of uncertainties, especially with the likelihood of tariffs on drugs imported into the US. Analysts warn that the proposed pharmaceutical tariffs could exacerbate supply issues.Over 50 percent of drugs used in the US are manufactured abroad. Generic sterile injectable drugs — like chemotherapy medications and IV saline — are particularly vulnerable due to their complex manufacturing processes and low profit margins. Generic drugs (which account for 90 percent of prescriptions filled in the US) could face increased pressure, as many rely on raw materials from China and India. This could result in more severe drug shortages in the future. 
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    #PharmaFlow by PHARMACOMPASS
    22 May 2025
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    Top Pharma Companies & Drugs in 2024: Merck’s Keytruda maintains top spot as Novo’s semaglutide nips at its heels

    Top Pharma Companies & Drugs in 2024: Merck’s Keytruda maintains top spot as Novo’s semaglutide nips at its heels

    In 2024, Big Pharma players consolidated and maintained their dominance, even as innovation continued to reshape the pharmaceutical landscape. The primary change last year was the meteoric rise of glucagon-like peptide-1 (GLP-1) receptor agonists that treat diabetes and help in weight loss.Amongst drugmakers, Pfizer retained its numero uno spot with an impressive US$ 63.6 billion in prescription drug sales (up 7 percent from US$ 59.56 billion reported in 2023), despite ever-shrinking Comirnaty sales, which settled at US$ 5.35 billion in 2024 (from US$ 11.22 billion in 2023).Merck secured the second position with revenues of US$ 57.4 billion, a growth of 7 percent over 2023. This performance was predominantly fueled by Keytruda, which now accounts for more than half of Merck’s total pharmaceutical revenue. Johnson & Johnson came a close third with US$ 57 billion in prescription drug sales (up from US$ 54.76 billion in 2023).AbbVie held the fourth position with US$ 56.33 billion in sales, achieving 3.7 percent growth despite the ongoing erosion of Humira revenue. This flagship immunology drug saw sales plummet 37.6 percent to approximately US$ 9 billion, a US$ 5.4 billion reduction compared to 2023. Humira’s loss was offset by AbbVie’s newer immunology assets, particularly Skyrizi and Rinvoq, both of which demonstrated exceptional growth trajectories. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available)European giants Astra, Roche, Novartis, Sanofi round out top 10 list; Novo, Lilly see astounding growthWhile the top four positions were dominated by American drugmakers, European giants dominated the lower half of the top 10 list.AstraZeneca secured the fifth spot with US$ 54.1 billion in sales, thereby posting impressive growth of 18.1 percent over 2023. Roche claimed the sixth position with US$ 50.9 billion in sales while Novartis ranked seventh — with sales of US$ 50.3 billion. Novartis' impressive 10.8 percent sales growth is attributed to its innovative medicines portfolio. Oncology therapies remained a cornerstone for both these Swiss drugmakers.Bristol Myers Squibb (BMS) secured eighth position with revenues of US$ 48.3 billion, representing 7.3 percent growth over the previous year. At US$ 45 billion, Eli Lilly posted 32 percent revenue growth last year. Its GLP-1 drug Mounjaro helped Lilly move up from the tenth in 2023 to the ninth spot last year.Sanofi landed the tenth position with US$ 42.6 billion in sales, propelled largely by the expanding indications of Dupixent. The French multinational has increasingly focused on this immunology blockbuster, while also garnering more sales from its vaccine and rare disease portfolios.Novo Nordisk merits a mention as it posted an incredible 26 percent year-on-year growth. It retained its eleventh spot with US$ 40.25 billion in sales. Novo’s growth was driven almost exclusively by the extraordinary success of its GLP-1 receptor agonist portfolio. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available)       Merck’s Keytruda retains throne with US$ 29.5 bn in sales, as Novo’s semaglutide nips at its heelsMoving on to drugs, Merck’s Keytruda (pembrolizumab) solidified its position as the world’s top-selling pharmaceutical product with sales exceeding US$ 29.5 billion and year-on-year growth of 17.88 percent (US$ 4.5 billion). This remarkable performance was driven by steady sales growth across more than 40 indications in the US. In 2024 alone, Keytruda secured four new approvals from the US Food and Drug Administration (FDA).However, Novo Nordisk’s semaglutide sales (Ozempic, Wegovy and Rybelsus) gave Keytruda a run for its money. Across the three blockbuster drugs, semaglutide earned the Danish drugmaker around US$ 28 billion — i.e. a year-on-year increase of 38 percent.Novo’s Ozempic (semaglutide) reached over US$ 16.7 billion in sales — a 20 percent increase from 2023. Originally approved in 2017 to improve glycemic control, Ozempic bagged additional approvals in 2020, and in January 2025. It is now approved to reduce the risk of major cardiovascular events, as well as to reduce cardiovascular risk and to lower the likelihood of chronic kidney disease in type 2 diabetes patients.Sales of Wegovy (semaglutide), the other blockbuster GLP-1 drug from Novo, grew by a whopping 85.7 percent to over US$ 8 billion.Sanofi and Regeneron’s Dupixent (dupilumab) secured the number three spot with sales of US$ 13.6 billion, representing an impressive 17.2 percent year-on-year growth. In 2024, Dupixent received three new approvals and one label update. Notably, it became the first-ever biologic medicine approved for patients with chronic obstructive pulmonary disease (COPD). View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available) AbbVie’s post-Humira strategy pays off as Skyrizi surges 51%; Lilly’s Mounjaro posts 124% growthGilead Sciences’ HIV treatment Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) showed robust growth of 13.27 percent, touching sales of US$ 13.42 billion in 2024 and emerging as the fourth largest selling drug. Biktarvy now commands over 50 percent of the US HIV treatment market. Unlike many other drugs on this list, Biktarvy faces no immediate patent challenges, with key protections expected to remain intact until 2033.BMS and Pfizer’s anticoagulant Eliquis (apixaban) claimed the fifth position with US$ 13.33 billion in sales, representing a 9.21 percent year-on-year increase. AbbVie’s Skyrizi (risankizumab) emerged as one of the fastest-growing assets with a 50.95 percent year-on-year increase, generating US$ 11.71 billion in 2024 sales, thereby surpassing Humira’s (adalimumab) diminished sales.This impressive performance, combined with Rinvoq’s (upadacitinib) growth, has prompted  AbbVie to raise its long-term outlook for these products. The company now expects combined Skyrizi and Rinvoq revenues to exceed US$ 31 billion by 2027, with Skyrizi alone projected to generate over US$ 20 billion.Johnson & Johnson’s Darzalex (daratumumab) claimed the seventh position with US$ 11.67 billion in sales, representing 19.77 percent growth over 2023.Lilly’s Mounjaro (tirzepatide) demonstrated dramatic growth with sales increasing 123.51 percent to US$ 11.54 billion. This performance was complemented by Zepbound (tirzepatide, for weight loss), which contributed US$ 4.9 billion to Lilly’s revenue. By the end of 2024, Mounjaro received FDA approval for a new indication in obstructive sleep apnea (OSA), becoming the first and only prescription medicine for moderate-to-severe OSA in adults with obesity.Stelara (ustekinumab) ranked ninth, bringing J&J sales of US$ 10.36 billion, showing a modest decline of 4.91 percent from its 2023 sales.Vertex’s triple-combination therapy Trikafta (elexacaftor/tezacaftor/ivacaftor) for treating cystic fibrosis rounded out the top ten list with sales of US$ 10.2 billion, up 14 percent from the previous year. View Our Interactive Dashboard on Top Drugs in 2024 by Sales (Free Excel Available) Our viewIn 2024, transformative therapies like GLP-1 receptor agonists drove growth in the pharmaceutical industry. This year, we expect GLP-1 drugs to dethrone Keytruda from the number one spot. Along with novel immunology agents, we expect GLP-1 drugs to realign the pharmaceutical market.  
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    24 Apr 2025
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    Top first-in-class drug candidates of 2025: Ionis’ donidalorsen, Sanofi’s fitusiran, Cytokinetics’ aficamten await FDA approval

    Top first-in-class drug candidates of 2025: Ionis’ donidalorsen, Sanofi’s fitusiran, Cytokinetics’ aficamten await FDA approval

    First‑in‑class drugs are therapies with entirely new approaches that improve patient outcomes and fundamentally change treatment paradigms.This week, PharmaCompass brings a compilation of 2025’s most promising first-in-class drug candidates. With their US Food and Drug Administration (FDA) action dates in 2025, many of these drugs, once approved, hold the potential of becoming blockbusters.Ionis’ donidalorsen, Sanofi’s fitusiran, Cytokinetics’ aficamten poised to transform patient careIonis’ donidalorsen is an exciting candidate designed to tackle hereditary angioedema (HAE), a rare condition marked by unpredictable and potentially life‑threatening swelling episodes.This novel antisense oligonucleotide works by “silencing” the messenger RNA that codes for prekallikrein — a protein that triggers inflammation leading to swelling. Instead of blocking a protein once it’s made, donidalorsen stops the cell from producing it in the first place. This precision approach could mean fewer infusions and reduced side effects compared to traditional treatments.Another promising candidate is Sanofi and Alnylam Pharmaceuticals’ fitusiran. It employs the technology of small interfering RNA (siRNA) to lower levels of antithrombin — a natural protein that, when in excess, can impair the blood’s ability to clot. By reducing antithrombin, fitusiran rebalances the blood’s clotting process in patients with hemophilia A and B.Similarly, Cytokinetics’ aficamten is designed to treat obstructive hypertrophic cardiomyopathy (oHCM), a condition in which the heart muscle becomes abnormally thick, obstructing blood flow. Aficamten works by inhibiting cardiac myosin, a protein that drives heart muscle contraction. This helps relieve symptoms like shortness of breath and chest pain. If approved, aficamten is expected to rake in annual sales of US$ 2.8 billion by 2030.UroGen, J&J’s candidates eye US$ 5 bn markets; AbbVie, Summit’s meds target lung cancerUroGen Pharma’s UGN‑102 is poised to redefine the treatment of non‑muscle‑invasive bladder cancer. This innovative formulation uses a reverse thermal gel technology that transforms from a liquid into a gel once inside the bladder. This change ensures that the chemotherapeutic agent, mitomycin, remains in contact with the bladder lining for a longer period, increasing its effectiveness at eradicating cancer cells and reducing the risk of recurrence.For patients, UGN‑102 could mean a non‑surgical, outpatient treatment option that is less invasive than traditional surgical methods. If approved, UGN-102 could address a US market of approximately 82,000 patients annually, translating into a market opportunity exceeding US$ 5 billion, according to company estimates.Johnson & Johnson’s nipocalimab is a new treatment aimed at helping people with autoimmune diseases — a group of conditions where the body’s defense system mistakenly attacks its own healthy cells. Nipocalimab works by blocking the neonatal Fc receptor (FcRn), thereby lowering the levels of pathogenic antibodies that drive many autoimmune disorders. J&J had acquired this FcRn blocker in 2020 as part of its US$ 6.5 billion takeover of Momenta Pharmaceuticals. J&J is trialing the drug in as many as 10 indications and expects peak annual sales in excess of US$ 5 billion.AbbVie’s antibody-drug conjugate (ADC), telisotuzumab vedotin, is designed as a “guided-missile” to deliver toxic drugs directly to cancer cells while sparing healthy tissues. Telisotuzumab vedotin targets c‑Met, a receptor that is over-expressed in certain cancers such as non‑small cell lung cancer (NSCLC). There are currently no approved anti-cancer therapies specifically for c-Met over-expressing NSCLC.Summit Therapeutics’ ivonescimab is a cutting‑edge bispecific antibody designed specifically for NSCLC. Unlike traditional therapies that target a single molecule, ivonescimab binds simultaneously to a tumor-specific antigen on cancer cells and to a receptor on T cells, effectively bringing these two together so the body’s own immune system can recognize and attack the tumor. This dual engagement strategy helps overcome common mechanism tumors.Insmed’s Brensocatib is an innovative, first‐in‐class oral inhibitor of dipeptidyl peptidase‑1 (DPP‑1) that targets a key step in the inflammatory cascade. DPP‑1 is responsible for activating neutrophil serine proteases — enzymes that, when overactive, can cause significant lung tissue damage in conditions such as non‑cystic fibrosis bronchiectasis. Brensocatib is expected to clock annual sales of US$ 2.8 billion by 2030.Gepotidacin, an investigational antibiotic developed by GSK, is poised to make a significant impact in the treatment of uncomplicated urinary tract infections (uUTIs) and urogenital gonorrhea. If approved, it would be the first oral antibiotic in a new class for uUTIs in over two decades.Arrowhead, Regenxbio, Ultragenyx address rare, genetic diseasesArrowhead Pharmaceuticals is developing an innovative gene-targeting therapy — plozasiran. This drug uses RNA interference (RNAi) to interrupt the gene responsible for producing apolipoprotein C‑III (APOC3), a protein that regulates blood triglyceride levels. For people with severe hypertriglyceridemia or familial chylomicronemia syndrome (FCS) — a severe and rare genetic disease for which there are currently no FDA‑approved treatments — high triglyceride levels can lead to pancreatitis and other serious cardiovascular issues. Regenxbio’s RGX‑121 is a one‑time gene therapy candidate for Hunter syndrome (MPS 2), a rare, inherited disorder that causes progressive neurological decline. The therapy uses a harmless virus to deliver a functional copy of the gene encoding iduronate‑2‑sulfatase (I2S) directly into the central nervous system. By restoring the missing enzyme, RGX‑121 aims to slow or even reverse the harmful buildup of substances in the brain that drive the disease’s progression.Another promising candidate is Ultragenyx Pharmaceuticals’ one-time intravenous gene therapy UX111 for Sanfilippo syndrome type A (MPS 3A). This devastating disorder, which leads to severe neurodegeneration in children, currently has no effective treatment. UX111 uses an adeno‑associated virus (AAV) to deliver a working copy of the SGSH gene, the deficiency of which is responsible for the disease. By enabling the body to produce the missing enzyme, UX111 holds the promise of slowing or even halting the progression of neurodegeneration.Our viewThis year has already seen several first-in-class approvals, such as Vertex’s suzetrigine (Journavx), a pioneering non‐opioid analgesic redefining pain management; SpringWorks’ mirdametinib (Gomekli), a breakthrough MEK inhibitor for a genetic disorder that often leads to the growth of benign tumors along nerves and; AstraZeneca and Daiichi’s ADC datopotamab deruxtecan (Datroway).Despite the volatile political environment in the US and its impact on federal agencies like the FDA, we are hopeful that many of the first-in-class drugs mentioned in this article will make a debut in 2025. 
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    #Phispers by PHARMACOMPASS
    27 Feb 2025
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    FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

    FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

    In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding. 
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    #PharmaFlow by PHARMACOMPASS
    30 Jan 2025
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    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    Since 2022, there has been a significant surge in layoffs by pharmaceutical and biotech companies. While this trend continued into 2024, the industry showed signs of stabilization in the last four months of the year with the pace of layoffs slowing down. Nonetheless, 2024 was a challenging year. Data compiled by PharmaCompass indicates that over 25,000 layoffs were announced in 2024, driven by economic pressures, failed clinical trials, and strategic pivots. Bristol Myers Squibb and Johnson & Johnson led the layoffs with about 2,300 job cuts each. Bayer announced elimination of 1,800 positions.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) US, Europe, China bear brunt of job cuts; Big Pharma hands pink slips to 10,000 Over 190 biopharma companies announced layoffs in 2024. The year began on a grim note — 27 firms announced significant job cuts in January 2024. By the yearend, Big Pharma alone had contributed more than 10,000 layoffs to the year’s total of over 25,000. Novartis announced over 1,200 job cuts in 2024. It eliminated 330 jobs after it acquired German biotech MorphoSys through the closure of sites in Munich and Boston. Similarly, Bayer announced significant reductions at its US and Swiss facilities.  North America saw increased retrenchments, especially at biotech hubs such as Boston, San Diego, and New Jersey. Massachusetts, with Boston and Cambridge as the epicenter of US biotechnology, saw around 4,000 layoffs, with companies like Relay Therapeutics, Editas Medicine, and Takeda driving the numbers. In San Diego, workforce reductions by Takeda, and Bavarian Nordic collectively resulted in over 900 job losses, significantly impacting the local biotech ecosystem. New Jersey was subject to broader restructuring efforts with BMS and Bayer contributing nearly 1,500 layoffs. The impact in Europe was equally severe. Germany, home to some of the world’s largest pharmaceutical companies, saw over 2,500 layoffs as Bayer and Boehringer Ingelheim scaled back operations. Novartis’ decision to shut down its Munich site added hundreds more to the tally. In Switzerland, Idorsia eliminated 270 positions. Dutch biotech UniQure reduced its workforce by 65 percent (around 300 jobs). That included the sale of a Massachusetts manufacturing facility to Genezen. Denmark also felt the strain, with Leo Pharma cutting 250 roles as part of a strategic revamp. China emerged as another focal point of workforce reductions in 2024. Global pharmaceutical giants, such as Merck and Johnson & Johnson, restructured their operations in response to market complexities in the region. Local companies such as Connect Biopharma, which is transitioning to a US-focused company, also scaled back their presence in the country.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Amylyx, FibroGen, Lyra, Athira drastically reduce staff over setbacks in clinical trials Clinical trial failures were one of the most significant drivers of layoffs in 2024. For instance, Amylyx Pharmaceuticals faced a devastating blow when its amyotrophic lateral sclerosis (ALS) therapy, Relyvrio, failed a confirmatory trial. This led to a 70 percent reduction in its workforce, leaving only 100 employees from the 384 full-time staff reported at the end of 2023. The company’s decision to pull the therapy from the market compounded the layoffs. BioMarin Pharmaceutical had to reduce its workforce, as it streamlined its pipeline in response to trial challenges. In August, the company announced a reduction of 225 employees, citing “organizational redesign efforts”. These layoffs followed 170 redundancies announced earlier in May. FibroGen, once considered a leader in oncology drug development, was among the most heavily impacted. The high-profile failure of its anti-CTGF antibody in two late-stage cancer trials led to the discontinuation of its lead candidate, resulting in a 75 percent reduction in its US workforce. Lyra Therapeutics also implemented a 75 percent workforce reduction, affecting 87 employees, after its chronic rhinosinusitis program struggled. Similarly, Athira Pharma cut 70 percent of its team after its Alzheimer’s candidate failed a phase 2/3 trial.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Cash crunch, mergers compel Kronos Bio, Editas, Vincerx, Gilead to downsize In addition to clinical failures, funding constraints played a pivotal role in reshaping the biotech landscape. Kronos Bio stood out as one of the hardest-hit firms, cutting 21 percent and 83 percent of its existing workforce in March and November, respectively, as it sought to divest assets and conserve cash. Editas Medicine’s inability to secure partnerships for its sickle cell program forced the company to revert to preclinical research, resulting in a 65 percent workforce reduction. The trend of scaling back R&D pipelines was particularly evident among biotechs struggling to advance preclinical programs to clinical trials. Boundless Bio and Senti Bio exemplified this, choosing to focus on a handful of promising candidates, while reducing discovery efforts. Consolidation often results in overlapping roles, leading to inevitable workforce reductions. Apart from the MorphoSys layoffs by Novartis, Vincerx Pharma faced job losses after it got acquired by Oqory (a clinical-stage ADC company). Vincerx had to cut its workforce by 55 percent.  Amid ongoing reorganization efforts, Gilead closed its Seattle, Washington (US), office and laid off 72 employees of its subsidiary Kite Pharma. Gilead also announced that its Kite facility in Philadelphia, Pennsylvania (US), would close by mid-2025. That was followed by 104 additional layoffs at its California headquarters. In April, it had cut 58 jobs in California. Gilead also announced that its Kite facility in Philadelphia would close by mid-2025. Vir Biotechnology reduced its workforce by 25 percent (i.e. 140 layoffs) to focus on its hepatitis program, and GlycoMimetics let go of 80 percent of its workforce after the FDA demanded an additional clinical trial for its leukemia treatment. Meanwhile, Lexicon Pharmaceuticals reduced its workforce by 60 percent after it stopped commercial operations and transitioned back to being a clinical stage company.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Our view It takes decades to build innovation ecosystems. The concentration of layoffs in major biotech hubs has raised concerns about the potential long-term impact on these ecosystems. In 2025, the key challenge will be to maintain the momentum of innovation, as organizations operate with a leaner workforce and a more focused pipeline.  
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    #PharmaFlow by PHARMACOMPASS
    16 Jan 2025
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    FDA’s landmark approvals of BMS’ schizo med, Madrigal’s MASH drug, US$ 16.5 bn Catalent buyout make it to top 10 news of 2024

    FDA’s landmark approvals of BMS’ schizo med, Madrigal’s MASH drug, US$ 16.5 bn Catalent buyout make it to top 10 news of 2024

    The year 2024 was marked by some landmark drug approvals in the areas of schizophrenia, metabolic dysfunction-associated steatohepatitis (MASH), chronic obstructive pulmonary disease (COPD) and Alzheimer’s disease. The incoming Trump administration, monkeypox outbreak and drug price negotiations in the US also created big news. Here is PharmaCompass’ compilation of the top 10 news from Phispers of 2024. I. BMS’ US$ 14 bn Karuna bet pays off with landmark FDA approval for schizophrenia med Cobenfy The US Food and Drug Administration’s groundbreaking approval of Bristol Myers Squibb’s Cobenfy to treat schizophrenia has made it to our number one spot. BMS had acquired Cobenfy through its US$ 14 billion purchase of Karuna Therapeutics, announced in December 2023. Cobenfy is the first-ever antipsychotic that targets cholinergic receptors. Cobenfy’s new approach has experts excited. Its peak sales are expected to come in at US$ 7.5 billion a year. While BMS’ Karuna buyout paid off, AbbVie’s US$ 8.7 billion acquisition of Cerevel Therapeutics was dampened when their lead candidate and schizophrenia drug emraclidine failed to meet phase 2 endpoints in two pivotal trials. II. 2024’s biggest deal, US$ 16.5 bn Catalent buyout by Novo’s parent, cleared after intense scrutiny  On number two spot is Novo Nordisk Foundation’s acquistion of Catalent via its investment arm Novo Holdings for US$ 16.5 billion, announced in February 2024. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. Easily the biggest biopharma acquisition of last year, the deal  faced criticism from lawmakers and consumer groups for its potential anti-competitive effects, particularly in the glucagon-like peptide-1 (GLP-1) drug market. Its main competitor Eli Lilly called for scrutiny by competition regulators. However, in December, both the EU regulator and the US Federal Trade Commission gave it the greenlight. III. Madrigal’s Rezdiffra becomes first FDA-approved drug for liver disease MASH For quite some time, the drug development field for the liver condition MASH had been a graveyard for failed programs. In 2024, the field celebrated a hurrah moment when Madrigal’s oral drug Rezdiffra became the first treatment in the US for adults with this common fatty liver disease. The approval has opened a multi-billion dollar opportunity for Madrigal with the American Liver Foundation CEO Lorraine Stiehl calling it a “game-changing” moment. IV. COPD patients get two new treatments — Verona’s Ohtuvayre and Sanofi-Regeneron’s Dupixent The COPD landscape saw remarkable advances in 2024. FDA approved Verona Pharma’s Ohtuvayre, which brings the first new mechanism of action in over two decades for the treatment of COPD. This dual-action, inhaled medication serves as both a bronchodilator and an anti-inflammatory agent, offering a comprehensive approach to symptom management. Adding to this progress, Sanofi and Regeneron’s Dupixent achieved a historic milestone by becoming the first biologic approved for treating COPD. Over 390 million people are living with COPD worldwide. V. Novartis inks 20 deals in 2024, promises over US$ 25 billion in biobucks, lays bets on radiopharmas Novartis has been investing in early-stage science, buying out companies in the sub-US$ 5 billion range. The Swiss drugmaker Novartis inked over 20 deals in 2024, paying over US$ 5.5 billion upfront and promising over US$ 25 billion in biobucks. The company has particularly focused on radiopharmaceuticals and molecular glue degraders. It acquired Mariana Oncology to strengthen its radioligand therapy (RLT) pipeline, and also inked RLT deals with PeptiDream and Ratio Therapeutics. VI. Despite political pressure, FDA rejects first MDMA-assisted therapy to treat PTSD; Lykos faces expanded probe In August, FDA declined to approve an MDMA-assisted therapy from Lykos Therapeutics to treat post-traumatic stress disorder (PTSD). In the lead-up to the FDA decision, 80 members of Congress from both sides of the aisle had urged US President Joe Biden and the FDA to consider further studies on the therapy. Not satisfied with just declining Lykos’ MDMA-assisted therapy for PTSD, FDA had expanded its investigation into the clinical trials that tested it. Lykos CEO Amy Emerson stepped down after reducing its workforce by 75 percent. Additionally, its founder Rick Doblin exited its board. VII. Alzheimer’s gets two new treatments as FDA approves Lilly’s Kisunla, Alpha Cognition’s Zunveyl FDA finally approved Eli Lilly’s Alzheimer’s drug Kisunla in July, after delaying action on it in March. This approval, along with that of Biogen and Eisai’s Leqembi in 2023, mark successes in treating the mind-wasting disease after three decades of failed efforts. FDA also approved Alpha Cognition’s Zunveyl to treat mild-to-moderate Alzheimer’s disease. Zunveyl is a prodrug of Alzheimer’s medication galantamine, and is to be taken orally twice a day. Alpha said Zunveyl is designed to address the tolerability issues with galantamine. VIII. IRA price talks conclude; Stelara, Enbrel, Eliquis to bring 51.4% of Medicare savings After filing futile lawsuits questioning the constitutional validity of the Medicare drug price negotiations under the Inflation Reduction Act (IRA), all drug companies came to the bargaining table. In August, the Biden-Harris Administration announced it had reached agreements for lower prices for all 10 drugs selected for negotiations under the IRA. The new prices come into effect from January 1, 2026. A Brookings Institution report said that just three drugs will account for over half of the expected US$ 6 billion savings in 2026. J&J’s Stelara (US$ 1.4 billion), Amgen’s Enbrel (US$ 1.1 billion), and BMS’ Eliquis (US$ 856 million) are expected to account for US$ 3.28 billion or 51.4 percent of Medicare savings. IX. Trump’s picks for new administration send shockwaves across markets, stocks of vaccine makers tumble  Donald Trump’s picks for his new administration not only created big news, but also impacted the stock markets. His selection of Robert F. Kennedy Jr., an anti-vaccine activist, to lead the Department of Health and Human Services (HHS), sent shares of several vaccine manufacturers plummeting. In the US, stocks of Pfizer, Moderna, and Novavax dipped. In Europe, stocks of BioNTech, GSK, and Bavarian Nordic tumbled. Trump has nominated Mehmet Oz, a celebrity TV host, to run the Centers for Medicare and Medicaid Services (CMS), which oversees health insurance. X. New mpox outbreak in Africa sparks global response; FDA approves Emergent’s vaccine to treat mpox In August, a new mpox virus clade put Africa in the throes of an mpox outbreak. The WHO declared it a public health emergency of international concern. Emergent BioSolutions said it will donate 50,000 doses of its smallpox vaccine ACAM2000. Multiple countries responded with donations of Bavarian Nordic’s Jynneos, the only widely-approved mpox vaccine at the time. In early September, the FDA approved Emergent’s ACAM2000 as the second mpox vaccine.
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    #Phispers by PHARMACOMPASS
    02 Jan 2025
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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    #PharmaFlow by PHARMACOMPASS
    21 Nov 2024
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    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    This year has seen pivotal advancements in medical innovation. The US Food and Drug Administration (FDA) has approved several groundbreaking therapies that promise to transform patient care across multiple therapeutic areas.Some of the therapies approved have revolutionary delivery mechanisms, while others are first-in-class treatments for previously unaddressed conditions. This week, PharmaCompass brings you a compilation of new pathbreaking approvals of 2024, including advancements in neurology, chronic conditions, mental health conditions, and innovative solutions for various other ailments.Lilly, Alpha Cognition, BMS transform neurological care with new Alzheimer’s, schizophrenia drugsThe neurological treatment landscape saw several major breakthroughs in 2024, particularly in the treatment of Alzheimer’s disease (AD). Eli Lilly’s Kisunla represents a significant advancement in treating early, symptomatic AD. Following decades of failed efforts, Kisunla’s approval, along with that of Eisai-Biogen’s Leqembi last year, marks a turning point in addressing AD.The drug works by targeting and clearing beta amyloid plaque from the brain, thereby attacking the disease’s underlying pathology, rather than just managing symptoms. Administered as an infusion every four weeks, Kisunla’s Medicare coverage makes it accessible to patients in the US who desperately need new treatment options. Alpha Cognition’s Zunveyl emerged as a promising new oral treatment for mild-to-moderate Alzheimer’s-related dementia. Only the second oral AD treatment approved by the FDA in over a decade, Zunveyl is a prodrug, or a biologically inactive compound that can be metabolized by the body to produce a drug. It remains inactive as it passes through the stomach and enhances cholinergic function in the brain.Perhaps one of the most exciting breakthroughs of 2024 was Bristol-Myers Squibb’s Cobenfy. This revolutionary antipsychotic medication for schizophrenia represents the first novel approach to treatment since the 1950s. Unlike traditional antipsychotics that target dopamine receptors, Cobenfy works through cholinergic receptors, offering new hope to patients who struggle with the side effects of conventional treatments.Traditional antipsychotics have been associated with several mild and serious side effects such as weight gain, feeling unmotivated and sluggish, high rates of cardiac disease, and even early death. Cobenfy’s innovative mechanism of action has generated excitement in the medical community. Experts project Cobenfy to bring in US$ 7.5 billion in peak annual sales, thereby validating BMS’ recent, US$ 14-billion acquisition of Karuna Therapeutics.Verona, Sanofi’s drugs revolutionize COPD care; Madrigal’s Rezdiffra offers hope to MASH patients The landscape of chronic obstructive pulmonary disease (COPD) treatment saw remarkable advances in 2024. Verona Pharma’s Ohtuvayre brings the first new mechanism of action in over two decades for COPD treatment. This dual-action, inhaled medication serves as both a bronchodilator and an anti-inflammatory agent, offering a comprehensive approach to symptom management.Adding to this progress, Sanofi and Regeneron’s Dupixent achieved a historic milestone by becoming the first biologic approved for treating COPD. Dupixent is Sanofi’s best-selling drug. It is poised to cross over € 21 billion (US$ 23.5 billion) in sales by 2030, with COPD likely to contribute US$ 2.9 billion, predict analysts. Over 390 million people are living with COPD worldwide.In the field of liver disease, Madrigal Pharmaceuticals’ Rezdiffra became the first FDA-approved treatment for metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring. This approval represents a breakthrough in a field that has been notorious for being a graveyard for failed programs. Rezdiffra offers hope to patients with this common liver condition, which primarily affects those with obesity or type 2 diabetes. The American Liver Foundation has termed this approval a “game-changing” moment in hepatology.For the rare disease community, Ipsen’s Iqirvo emerged as the first new medicine approved in nearly a decade for primary biliary cholangitis (PBC). This first-in-class peroxisome proliferator-activated receptor (PPAR) agonist offers new hope for the approximately 100,000 Americans affected by this condition, particularly women aged 30 to 60 years.A significant breakthrough for patients with hypoparathyroidism came with the approval of Ascendis’ Yorvipath, making it the only treatment for hypoparathyroidism in adults. By directly addressing the underlying hormone deficiency, Yorvipath helps stabilize calcium levels in the blood, reducing the treatment burden associated with managing symptoms through calcium and vitamin D supplements alone.In the realm of pulmonary medicine, Merck’s Winrevair emerged as the first new therapy for pulmonary arterial hypertension (PAH) in over a decade. As the first approved activin-signaling inhibitor therapy, Winrevair represents a novel approach to treating this rare but severe condition that doctors call a “ticking time bomb”. The drug is the first treatment that targets the underlying cause of the lung condition, which typically leads to death within a decade of diagnosis.ARS Pharma launches nasal spray alternative to EpiPen, Eicos introduces med for severe frostbiteLeading the charge in innovative drug delivery is ARS Pharma’s Neffy, the first-ever nasal spray alternative to the EpiPen for treating severe allergic reactions. This groundbreaking advancement represents the first major innovation in anaphylaxis treatment in over a decade. For children and individuals with needle phobia, this nasal spray format addresses one of the most significant barriers to timely treatment of allergic emergencies. Speaking of emergency medicine, Eicos Sciences’ Aurlumyn made history as the first FDA-approved treatment for severe frostbite. This approval fills a critical gap in emergency care, offering a medical intervention that could prevent the need for amputation in severe cases.The cardiovascular space saw its first oral anti-hypertensive therapy that works through a new therapeutic pathway in almost 40 years. Idorsia’s Tryvio is a treatment for hypertension that offers new hope to patients whose blood pressure remains inadequately controlled on existing medications. Idorsia expects millions of patients to benefit from it.Our view This year, the pharmaceutical industry has taken a remarkable leap forward by addressing some of healthcare’s most challenging conditions. Treatments like BMS’ Cobenfy for schizophrenia and Madrigal’s Rezdiffra for MASH demonstrate the industry’s growing ability to translate science into practical therapies. With the growing use of artificial intelligence in the drug industry, we hope that these approvals are just a precursor to a bevy of pathbreaking therapies in the years to come. 
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    14 Nov 2024
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    US, Europe turn to advanced manufacturing, stockpiling to strengthen drug supply chains

    US, Europe turn to advanced manufacturing, stockpiling to strengthen drug supply chains

    Over the last few decades, the United States and Europe have saved trillions of dollars by importing drugs from countries like China and India. Their journey wasn’t easy, with regulatory non-compliance and drug patent scams raising their ugly heads every now and then. The Covid-19 pandemic and the accompanying lockdowns were a wake-up call for these countries to take a long, hard look at their sourcing strategies.Over the last few years, both the US and Europe have embarked on policy changes and ambitious programs to strengthen their drug supply chains. PharmaCompass takes you through US and Europe’s journeys towards more robust pharmaceutical supply chains.Biden’s executive order, CARES Act, state-backed investments strengthen US supply chainDuring the early days of the pandemic, the US government (under former President Donald Trump)  had enacted the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to address the economic fallout of the pandemic through a US$ 2.2 trillion stimulus. Through this act, the FDA had taken several drug shortage mitigation efforts. The new administration under President Joe Biden undertook more measures. Notable amongst them was Executive Order 14017 on America’s supply chains. It mandated a comprehensive 100-day review to identify vulnerabilities in key sectors, including pharmaceuticals and active pharmaceutical ingredients (APIs). The review noted that 87 percent of generic API facilities are located overseas, leaving the US healthcare system vulnerable to shortages of essential medicines.Through a Presidential Determination, Biden had also broadened US Department of Health and Human Services’ (HHS) authorities under the Defense Production Act (DPA) of 1950. HHS can now enable investment in domestic manufacturing of essential medicines and medical countermeasures under the DPA. The HHS has invested US$ 17 billion in domestic manufacturing for the medical supply chain, including US$ 500 million to support API manufacturing.Under this effort, Merck has been awarded a €121 million (US$ 132 million) government contract to set up a lateral flow membrane production facility at Sheboygan, Wisconsin. Similarly, California has launched an initiative (known as CalRx) and is working with CIVICA to make US$ 30 insulin available to all who need it.Europe encourages reshoring; EDQM develops monographs for unlicensed alternativesIn recent years, Europe has faced shortages of insulin, antibiotics, oncology drugs, corticosteroids and even paracetamol. To overcome these shortages, the European Medicines Agency (EMA) is encouraging drugmakers to enhance manufacturing capacity and diversify suppliers.There is change visible on the ground. Companies like Midas Pharma, EUROAPI, Seqens are setting up API plants in Europe. Seqens has taken steps to reshore paracetamol production in France and is constructing a new € 100 million (US$ 109 million) production unit in Roussillon. Sanofi is investing €1.3 billion (US$ 1.4 billion) in a new insulin production facility at its existing site in Frankfurt. Similarly, Sandoz has set up a new antibiotic production plant in Austria and a new biosimilar development center in Germany.That said, we know that manufacturing capacities take time to build and are often financially unviable in the developed world. Ergo, a particularly innovative initiative has come from the European Directorate for the Quality of Medicines & HealthCare (EDQM). Their project aims to develop monographs detailing the preparation and testing of unlicensed drugs that can fill the gap left when licensed medicinal products are unavailable. To facilitate this initiative, the European Pharmacopoeia Commission is recruiting experts to verify proposed production methods and analytical procedures.The other means of guarding against supply and demand fluctuations is stockpiling. The EMA has advised the European Commission (EC) and marketing authorization holders (MAH) to stockpile medicines. The regulator has also asked MAHs to establish a shortage prevention plan for critical medicines. Europe’s Health Emergency Response Authority (HERA) is taking a systematic approach to stockpile management.Despite these measures, costs and market structures pose serious challenges. Medicines for Europe, representing the generic and biosimilar medicines industry, has raised concerns about the current market structures. They argue that government purchasing practices, which prioritize obtaining the lowest prices for off-patent medicines, are jeopardizing the European manufacturing footprint and discouraging investments in supply chain resilience.FDA, EMA promote continuous manufacturing; US relies on digital stockpilesDuring the pandemic, there were acute shortages of oncology, cardiovascular, anesthesia, anti-infective, neurological and anti-allergic drugs in the US. A 2022 study undertaken by the Washington University points out that there is excess manufacturing capacity in the US that can be considered for reshoring critical and essential drugs. In fact, 49 percent of generic drug manufacturing capacity in the US is lying idle, and many others are working at less than 50 percent capacity. These capacities can be repurposed. Various advanced manufacturing technologies, such as  “continuous flow and on-demand manufacturing capabilities in idled manufacturing sites offer the ability to reduce production cost,” says this report.FDA has been promoting “advanced manufacturing” technologies, such as continuous manufacturing, which are now a part of America’s overall strategy to strengthen and secure the pharmaceutical supply chain. The EMA has also released guidelines on continuous manufacturing of drug substances and drug products. Advanced manufacturing is a collective term for new or innovative medical product manufacturing technologies. Unlike batch manufacturing, which involves sequential processing and testing of material across multiple discrete stages (and often discrete facilities), continuous manufacturing combines the full manufacturing stream into a single, fully integrated flow. While continuous manufacturing may not be suitable for every drug manufacturing process, but where applicable, it tends to eliminate built-in production gaps and shortens the time taken to manufacture a drug from months to days.In the US, the Strategic National Stockpile (SNS) plays a critical role in ensuring the availability of essential medical supplies during emergencies. It now also involves a digital stockpile that does not store physical goods and products. Instead, it stores electronic plans, instructions, and methods to make and test medical products. Digital stockpiles rely on one or more trusted suppliers that can make the product from the digital information, either through methods like 3D printing or self-contained distributed manufacturing lines.Our viewThe global pharmaceutical supply chain is a complex web spanning multiple countries and continents. While advanced manufacturing and stockpiling may work to an extent, a large chunk of generic drugs and APIs will continue to come from countries like China and India.In order to reduce reliance on China, the US has been proactively expanding its collaboration with India. But this time, there is increased emphasis on quality control. While FDA is increasing the number of inspections at Indian drug plants, the Indian government, on its part, has revised rules for drug manufacturing, with higher GMP standards.Taken together, a multi-pronged approach to addressing supply chain vulnerabilities should secure drug supplies to the US and Europe in the years to come.  
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    17 Oct 2024
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    BMS, Bayer, Takeda, Pfizer downsize to combat cost pressures, meet restructuring plans

    BMS, Bayer, Takeda, Pfizer downsize to combat cost pressures, meet restructuring plans

    Over the last two years, there has been a significant surge in layoffs by pharmaceutical and biotech companies. The trend spilled over to 2024. Data compiled by PharmaCompass indicates that between January and early-September, around 150 companies had implemented layoffs. Bristol Myers Squibb (BMS) tops the list of companies that downsized, with a staggering 2,284 job cuts. Bayer stood second at 1,816 retrenchments, followed by Takeda Pharmaceuticals at 1,155. Johnson & Johnson’s spin-off Kenvue is slashing over 1,000 jobs this year, while Roche subsidiary Genentech is cutting 529 positions, and Novartis is going ahead with its multi-year restructuring, and cutting another 770 jobs. One of the primary drivers of layoffs has been the need for companies to streamline operations and reduce costs. Many firms have faced financial pressures due to reasons such as declining revenues, increased competition, and the high costs associated with drug development. The current wave of layoffs has encompassed geographies – from traditional pharma strongholds like New Jersey, biotech hubs in Massachusetts and California, to Europe (particularly Germany and Switzerland). This is not to suggest that job cuts are a norm. Certain segments have been experiencing substantial growth and job creation. This includes companies like Eli Lilly and Novo Nordisk that have experienced remarkable growth due to the efficacy of their glucagon-like peptide-1 (GLP-1) receptor agonists, a class of drugs that treats type 2 diabetes and obesity.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available) BMS cuts 2,284 jobs to meet cost targets, Bayer hands pink slips to 1,816 employees Several large drugmakers have announced job cuts this year in order to meet their cost cutting goals, or as part of their restructuring exercise. BMS’ revenue had declined from US$ 46.2 billion in 2022 to US$ 45 billion in 2023. The financial pressure has compelled it to cut 2,284 jobs so far in this year, a move that sent shockwaves through the industry. Overall, BMS hopes to save approximately US$ 1.5 billion in costs by 2025 through this “strategic productivity initiative”. In Europe, Swiss-based companies like Novartis and Roche have announced substantial job cuts, while Bayer is reducing its workforce globally.  Bayer is laying off 1,816 employees worldwide, including 150 in Basel, Switzerland. A majority of these are management roles as the German drugmaker seeks to target € 500 million (US$ 557 million) in cost savings in 2024 and € 2 billion (US$ 2.23 billion) in 2026. Japanese drugmaker Takeda plans to eliminate 1,155 positions, including 324 jobs in San Diego and 641 in Massachusetts. Takeda is also winding down production and R&D operations in Austria, resulting in 190 job losses. Starting next month, Genentech, a Roche subsidiary, will lay off 93 employees in San Francisco. Earlier this year, Genentech trimmed roughly 3 percent of its workforce across several departments, impacting 436 employees. Roche also laid off around 340 employees in its product development team. Novartis has been undergoing a significant restructuring exercise since 2022, when it announced 8,000 job cuts in its global workforce. This year, it announced an additional 770 job cuts in its product development organization, separate from the previous reductions. Once again, it was workforces in Switzerland (440 job cuts) and US (269 job cuts) that bore the brunt. Tylenol and Band-Aid maker Kenvue, which spun off from J&J last year, announced plans to cut 920 jobs, representing about 4 percent of its global workforce. Additionally, the company will lay off 51 employees in New Jersey and 84 in California. These layoffs are part of Kenvue’s efforts to adjust its cost structure and become more competitive.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Perrigo, Emergent Bio, Catalent, BioMarin trim workforces amid strategic shifts Several mid-size companies too are under tremendous cost pressures, with some of them feeling the need to reinvent themselves for the future. In February this year, Perrigo had embarked on ‘Project Energize’, a three-year initiative aimed at boosting organizational agility and achieving long-term success. As part of this project, Perrigo is cutting costs and laying off 6 percent of its staff, which translates into nearly 550 employees. CDMO-turned-biopharma Emergent BioSolutions plans to reduce its workforce by about 300 employees. The Maryland-based multinational is closing its Baltimore-Bayview drug substance manufacturing facility and its Rockville drug product facility in the state. Rare disease biotech BioMarin laid off 395 employees globally, about 12 percent of its workforce, as part of “organizational redesign efforts” to prioritize its new strategy with its hemophilia A gene therapy Roctavian and to preserve cash. Drug-delivery specialist Catalent has also been significantly impacted by restructuring efforts ever since it announced 1,100 layoffs in December. It had then attributed its fall in revenue to declining Covid-related sales, but had also noted that future GLP-1 manufacturing revenues could help stabilize its finances. True enough — it subsequently announced that it is in the process of being acquired by Novo Nordisk’s parent company for US$ 16.5 billion. However, Catalent reported reducing its headcount by an additional 300 in the fourth quarter of 2023.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Pfizer job cuts continue to trickle in; Lykos, Lyra downsize after pipeline setbacks Clinical trial failures and financial constraints have also played a significant role in this year’s wave of layoffs. At Pfizer, job cuts continued to trickle in, with some estimates putting the number at 1,500 employees in 2024. These include 285 at its vaccine R&D site in New York, and 52 in San Francisco. The Comirnaty maker also pulled the plug on a long-anticipated, near-complete Seagen drug manufacturing plant in Everett, Washington. About 120 employees at the site were let go.  It has been a tumultuous time for Lykos Therapeutics, following the US Food and Drug Administration’s rejection of its MDMA-assisted therapy for post-traumatic stress disorder. Lykos announced laying off 75 percent of its staff (i.e. 75 employees). Its founder, who had spent 38 years working on the therapy, left the company and so did its CEO. However, Lykos has not given up and has roped in a Janssen veteran as senior medical advisor to get the therapy past the finish line. Similarly, Lyra Therapeutics is laying off 75 percent of its workforce (i.e. 87 employees) following disappointing late-stage results for its implant to treat chronic rhino-sinusitis. The retrenchments include its chief technology officer.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Our view Technology, regulatory and pricing pressures are shaping strategies of pharmaceutical companies. The drive to do more with less could accelerate the adoption of artificial intelligence, machine learning, and automation in drug discovery and development processes. The employment landscape is certainly evolving. We foresee significant changes in the skills required for pharmaceutical and biotech careers, with a growing emphasis on data science and computational biology.
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    #PharmaFlow by PHARMACOMPASS
    19 Sep 2024
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    Sanofi pens $395M China pact for Arrowhead Metabolic med
    Sanofi pens $395M China pact for Arrowhead Metabolic med

    02 Aug 2025

    // PRESS RELEASE

    https://ir.arrowheadpharma.com/news-releases/news-release-details/arrowhead-subsidiary-visirna-sells-rights-hypertriglyceridemia

    PRESS RELEASE
    02 Aug 2025
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    Sanofi`s Avapro Receives Approval in US
    Sanofi`s Avapro Receives Approval in US

    01 Aug 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219840

    FDA
    01 Aug 2025
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    Q4 Sales Up 10.3%, EPS Beats FY24, Rebound Expected in 2025
    Q4 Sales Up 10.3%, EPS Beats FY24, Rebound Expected in 2025

    31 Jul 2025

    // PRESS RELEASE

    https://www.sanofi.com/assets/dotcom/pressreleases/2025/2025-01-30-06-30-00-3017713-en.pdf

    PRESS RELEASE
    31 Jul 2025
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    Sanofi’s SAR446523 Gets US Orphan Drug Tag For Multiple Myeloma
    Sanofi’s SAR446523 Gets US Orphan Drug Tag For Multiple Myeloma

    31 Jul 2025

    // PRESS RELEASE

    https://www.sanofi.com/en/media-room/press-releases/2025/2025-07-30-05-00-00-3123737

    PRESS RELEASE
    31 Jul 2025
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    Sanofi’s Sarclisa Approved in EU for Multiple Myeloma
    Sanofi’s Sarclisa Approved in EU for Multiple Myeloma

    25 Jul 2025

    // PRESS RELEASE

    https://www.sanofi.com/en/media-room/press-releases/2025/2025-07-25-05-00-00-3121591

    PRESS RELEASE
    25 Jul 2025
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    Sanofi Supports Film About Women's Experiences with Hemophilia
    Sanofi Supports Film About Women's Experiences with Hemophilia

    24 Jul 2025

    // FIERCE PHARMA

    https://www.fiercepharma.com/marketing/sanofi-lends-support-dismissed-film-about-5-womens-experiences-hemophilia

    FIERCE PHARMA
    24 Jul 2025
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    ALL APIs

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    01

    Irbesartan

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10310

    Submission : 1993-06-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-160 - Rev 01

    Issue Date : 2024-02-14

    Type : Chemical

    Substance Number : 2465

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10180

    Registrant's Address : 82 Avenue Raspail 94250 Gentilly (FRANCE)

    Initial Date of Registration : 2013-09-18

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
    Sanofi Company Banner

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    #PipelineProspector

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    02

    Chlorpromazine Hydrochloride

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-03

    Pay. Date : 2013-02-13

    DMF Number : 1516

    Submission : 1970-04-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1999-043 - Rev 08

    Issue Date : 2024-02-16

    Type : Chemical

    Substance Number : 475

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 50396-7515

    Start Marketing Date : 2011-06-29

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Sanofi Company Banner

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    03

    Promethazine Hydrochloride

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-26

    Pay. Date : 2013-02-13

    DMF Number : 1949

    Submission : 1972-06-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1992-002 - Rev 07

    Issue Date : 2024-02-15

    Type : Chemical

    Substance Number : 524

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 50396-7517

    Start Marketing Date : 2011-06-29

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Sanofi Company Banner

    Product
    Web Link

    Stock Recap
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    Market
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    04

    Zolpidem Tartrate

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20984

    Submission : 2007-10-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2001-071 - Rev 05

    Issue Date : 2024-03-28

    Type : Chemical

    Substance Number : 1280

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Sanofi Company Banner

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    05

    Clorazepate Dipotassium

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Attending
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4252

    Submission : 1981-08-10

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2008-170 - Rev 02

    Issue Date : 2024-03-28

    Type : Chemical

    Substance Number : 898

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Sanofi Company Banner

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    06

    Trimipramine

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4078

    Submission : 1981-02-18

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2003-121 - Rev 04

    Issue Date : 2024-02-02

    Type : Chemical

    Substance Number : 534

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Sanofi Company Banner

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    07

    Zopiclone

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 3316

    Submission : 1978-08-30

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1996-016 - Rev 14

    Issue Date : 2024-05-06

    Type : Chemical

    Substance Number : 1060

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Alfuzosin HCl

    France

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20888

    Submission : 2007-09-27

    Status : Active

    Type : II

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    Cabazitaxel

    France

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23496

    Submission : 2010-01-29

    Status : Active

    Type : II

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    10

    Clopidogrel

    France

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14809

    Submission : 2000-03-31

    Status : Active

    Type : II

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    JDMF

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    HyluMed Sterile HMW Sodium Hyaluronate

    France
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    Sanofi

    Registration Number : 222MF10066

    Registrant's Address : 50 Binney Street, Cambridge, MA 02142, USA

    Initial Date of Registration : 2010-02-22

    Latest Date of Registration : 2021-06-15

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    HyluMed Sterile Sodium Hyaluronate

    France
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    Sanofi

    Registration Number : 220MF10251

    Registrant's Address : 500 Kendall Street, Cambridge, Massachusetts 02142, U.S. S. A.

    Initial Date of Registration : 2008-12-11

    Latest Date of Registration : 2008-12-11

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    03

    Inactivated polio vaccine (Salk vaccine)

    France
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    Sanofi

    Registration Number : 224MF10124

    Registrant's Address : 14 Espace Henry Valle(´)e 69007 Lyon France

    Initial Date of Registration : 2012-07-09

    Latest Date of Registration : 2019-01-21

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    04

    Irbesartan

    France
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    Registration Number : 225MF10180

    Registrant's Address : 82 Avenue Raspail 94250 Gentilly (FRANCE)

    Initial Date of Registration : 2013-09-18

    Latest Date of Registration : 2022-06-01

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    05

    Sodium hyaluronate

    France
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    Sanofi

    Registration Number : 219MF10034

    Registrant's Address : 50 Binney Street, Cambridge, MA 02142, USA

    Initial Date of Registration : 2007-02-05

    Latest Date of Registration : 2021-06-15

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    KDMF

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    Grape seed extract

    France
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    Registrant Name : Saehan Pharmaceutical Co., Ltd.

    Registration Date : 2019-06-28

    Registration Number : 20180516-7-K-33-01(1)

    Manufacturer Name : Sanofi Winthrop Industrial@IND...

    Manufacturer Address : Route d'Avignon 30390 ARAMON, France@38 Avenue Gustave Eiffel BP9528, TOURS, 37095

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    Grape seed extract

    France
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    Sanofi

    Registrant Name : Hanlim Pharmaceutical Co., Ltd.

    Registration Date : 2018-05-16

    Registration Number : 20180516-7-K-33-01

    Manufacturer Name : Sanofi Winthrop Industrial@IND...

    Manufacturer Address : Route d'Avignon 30390 ARAMON, France@38 avenue Gustave Eiffel BP9528, TOURS, 37095

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    03

    Sodium hyaluronate

    France
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    Sanofi

    Registrant Name : Korea Alcon Co., Ltd.

    Registration Date : 2008-05-07

    Registration Number : 20080507-96-E-55-14

    Manufacturer Name : Genzyme Corporation

    Manufacturer Address : 76 New York Avenue, Framingham, MA 01701-9322

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    Teicoplanin

    France
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    Sanofi

    Registrant Name : Sanofi-Aventis Korea Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-63-A-127-01

    Manufacturer Name : EUROAPI ITALY SRL

    Manufacturer Address : Via Angelo Titi 22/26 – 72100 Brindisi, Italy

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    NDC API

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    APOMORPHINE HYDROCHLORIDE

    France
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    Sanofi

    NDC Package Code : 52465-105

    Start Marketing Date : 2014-06-05

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    APOMORPHINE HYDROCHLORIDE

    France
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    Sanofi

    NDC Package Code : 50396-6009

    Start Marketing Date : 2014-06-05

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    03

    APOMORPHINE HYDROCHLORIDE

    France
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    Sanofi

    NDC Package Code : 52465-104

    Start Marketing Date : 2014-06-05

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    04

    APOMORPHINE HYDROCHLORIDE

    France
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    Sanofi

    NDC Package Code : 50396-6007

    Start Marketing Date : 2014-06-05

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    CHLORPROMAZINE HYDROCHLORIDE

    France
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    Sanofi

    NDC Package Code : 50396-7515

    Start Marketing Date : 2011-06-29

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    CYANOCOBALAMIN

    France
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    Sanofi

    NDC Package Code : 50396-7800

    Start Marketing Date : 2011-06-29

    End Marketing Date : 2026-08-15

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

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    HYDROCORTISONE

    France
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    Sanofi

    NDC Package Code : 50396-7004

    Start Marketing Date : 2011-02-07

    End Marketing Date : 2026-07-26

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    HYDROXOCOBALAMIN

    France
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    Sanofi

    NDC Package Code : 50396-7902

    Start Marketing Date : 2015-02-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

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    HYDROXOCOBALAMIN ACETATE

    France
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    Sanofi

    NDC Package Code : 50396-7900

    Start Marketing Date : 2015-02-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

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    10

    NALBUPHINE HYDROCHLORIDE

    France
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    Sanofi

    NDC Package Code : 52465-106

    Start Marketing Date : 2018-06-19

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Sanofi to Acquire Vicebio, Expanding Respiratory Vaccines Pipeline

    Details:

    Through the acquisition, Sanofi will leverage VXB-241, an early-stage combination vaccine candidate targeting respiratory syncytial virus (RSV) and hMPV, both of which are respiratory viruses.


    Lead Product(s): VXB-241

    Therapeutic Area: Infections and Infectious Diseases Brand Name: VXB-241

    Study Phase: Phase IProduct Type: Vaccine

    Recipient: Vicebio

    Deal Size: $1,600.0 million Upfront Cash: $1,150.0 million

    Deal Type: Acquisition July 22, 2025

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    Sanofi

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    Lead Product(s) : VXB-241

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase I

    Recipient : Vicebio

    Deal Size : $1,600.0 million

    Deal Type : Acquisition

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    Sanofi to Acquire Vicebio, Expanding Respiratory Vaccines Pipeline

    Details : Through the acquisition, Sanofi will leverage VXB-241, an early-stage combination vaccine candidate targeting respiratory syncytial virus (RSV) and hMPV, both of which are respiratory viruses.

    Product Name : VXB-241

    Product Type : Vaccine

    Upfront Cash : $1,150.0 million

    July 22, 2025

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    Sanofi Completes Acquisition of Blueprint Medicines

    Details:

    The acquisition includes a rare immunology disease medicine, Ayvakit/Ayvakyt (avapritinib), approved in the US and the EU, and a promising advanced and early-stage immunology pipeline.


    Lead Product(s): Avapritinib

    Therapeutic Area: Immunology Brand Name: Ayvakit

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Recipient: Blueprint Medicines

    Deal Size: $9,500.0 million Upfront Cash: $9,100.0 million

    Deal Type: Acquisition July 18, 2025

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    Sanofi

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    Lead Product(s) : Avapritinib

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Recipient : Blueprint Medicines

    Deal Size : $9,500.0 million

    Deal Type : Acquisition

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    Sanofi Completes Acquisition of Blueprint Medicines

    Details : The acquisition includes a rare immunology disease medicine, Ayvakit/Ayvakyt (avapritinib), approved in the US and the EU, and a promising advanced and early-stage immunology pipeline.

    Product Name : Ayvakit

    Product Type : Other Small Molecule

    Upfront Cash : $9,100.0 million

    July 18, 2025

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    Sanofi’s SAR446597 Earns Fast Track Designation in the US for Geographic Atrophy

    Details:

    SAR446597 is a one-time intravitreal gene therapy, which is being evaluated for the treatment of geographic atrophy (GA) due to age-related macular degeneration


    Lead Product(s): SAR446597

    Therapeutic Area: Ophthalmology Brand Name: SAR446597

    Study Phase: IND EnablingProduct Type: Cell and Gene therapy

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 16, 2025

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    Sanofi

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    Lead Product(s) : SAR446597

    Therapeutic Area : Ophthalmology

    Highest Development Status : IND Enabling

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Sanofi’s SAR446597 Earns Fast Track Designation in the US for Geographic Atrophy

    Details : SAR446597 is a one-time intravitreal gene therapy, which is being evaluated for the treatment of geographic atrophy (GA) due to age-related macular degeneration

    Product Name : SAR446597

    Product Type : Cell and Gene therapy

    Upfront Cash : Inapplicable

    July 16, 2025

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    Adagene announces up to $25 million strategic investment from Sanofi

    Details:

    The Company plans to use the proceeds to fund its clinical development of ADG126 (muzastotug), an anti-CTLA-4 SAFEbody, through phase 2 trial in microsatellite stable colorectal cancer (MSS CRC).


    Lead Product(s): AMP945,Pembrolizumab

    Therapeutic Area: Oncology Brand Name: ADG126

    Study Phase: Phase IIProduct Type: Antibody

    Recipient: Adagene Suzhou Limited

    Deal Size: $25.0 million Upfront Cash: Undisclosed

    Deal Type: Financing July 01, 2025

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    Sanofi

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    Lead Product(s) : AMP945,Pembrolizumab

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Recipient : Adagene Suzhou Limited

    Deal Size : $25.0 million

    Deal Type : Financing

    DEALS_DEV arrow-down

    Adagene announces up to $25 million strategic investment from Sanofi

    Details : The Company plans to use the proceeds to fund its clinical development of ADG126 (muzastotug), an anti-CTLA-4 SAFEbody, through phase 2 trial in microsatellite stable colorectal cancer (MSS CRC).

    Product Name : ADG126

    Product Type : Antibody

    Upfront Cash : Undisclosed

    July 01, 2025

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    Kymera Therapeutics Announces Sanofi IRAK4 Collaboration Update

    Details:

    Sanofi has informed Kymera that KT-485/SAR447971, an oral, highly potent and selective development candidate targeting IRAK4 has been selected to advance into clinical studies.


    Lead Product(s): SAR447971

    Therapeutic Area: Dermatology Brand Name: KT-485

    Study Phase: IND EnablingProduct Type: Other Small Molecule

    Recipient: Kymera Therapeutics

    Deal Size: $2,150.0 million Upfront Cash: $150.0 million

    Deal Type: Collaboration June 25, 2025

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    Sanofi

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    Lead Product(s) : SAR447971

    Therapeutic Area : Dermatology

    Highest Development Status : IND Enabling

    Recipient : Kymera Therapeutics

    Deal Size : $2,150.0 million

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Kymera Therapeutics Announces Sanofi IRAK4 Collaboration Update

    Details : Sanofi has informed Kymera that KT-485/SAR447971, an oral, highly potent and selective development candidate targeting IRAK4 has been selected to advance into clinical studies.

    Product Name : KT-485

    Product Type : Other Small Molecule

    Upfront Cash : $150.0 million

    June 25, 2025

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    Dupixent Approved In US As First Targeted Therapy For Bullous Pemphigoid

    Details:

    Dupixent (dupilumab) is an interleukin-4/13 receptor alpha antagonist, indicated for the treatment of adult patients with bullous pemphigoid (BP).


    Lead Product(s): Dupilumab

    Therapeutic Area: Immunology Brand Name: Dupixent

    Study Phase: Approved FDFProduct Type: Antibody

    Recipient: Regeneron Pharmaceuticals

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 20, 2025

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    Sanofi

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    Lead Product(s) : Dupilumab

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Recipient : Regeneron Pharmaceuticals

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Dupixent Approved In US As First Targeted Therapy For Bullous Pemphigoid

    Details : Dupixent (dupilumab) is an interleukin-4/13 receptor alpha antagonist, indicated for the treatment of adult patients with bullous pemphigoid (BP).

    Product Name : Dupixent

    Product Type : Antibody

    Upfront Cash : Inapplicable

    June 20, 2025

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    Virtual Booth

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    Sanofi to buy US biopharma group Blueprint for up to $9.5 billion

    Details:

    The acquisition includes a rare immunology disease medicine, Ayvakit/Ayvakyt (avapritinib), approved in the US and the EU, and a promising advanced and early-stage immunology pipeline.


    Lead Product(s): Avapritinib

    Therapeutic Area: Immunology Brand Name: Ayvakit

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Recipient: Blueprint Medicines

    Deal Size: $9,500.0 million Upfront Cash: $9,100.0 million

    Deal Type: Acquisition June 02, 2025

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    Sanofi

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    Lead Product(s) : Avapritinib

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Recipient : Blueprint Medicines

    Deal Size : $9,500.0 million

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Sanofi to buy US biopharma group Blueprint for up to $9.5 billion

    Details : The acquisition includes a rare immunology disease medicine, Ayvakit/Ayvakyt (avapritinib), approved in the US and the EU, and a promising advanced and early-stage immunology pipeline.

    Product Name : Ayvakit

    Product Type : Other Small Molecule

    Upfront Cash : $9,100.0 million

    June 02, 2025

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    Recludix Names Oral STAT6 Inhibitor Candidate for Inflammatory Diseases with Sanofi

    Details:

    The collaboration aims to advance preclinical studies, REX-8756, an oral, selective and reversible small molecule inhibitor of STAT6. It is being evaluated for asthma, COPD etc.


    Lead Product(s): REX-8756

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: REX-8756

    Study Phase: PreclinicalProduct Type: Other Small Molecule

    Recipient: Recludix Pharma

    Deal Size: $1,325.0 million Upfront Cash: Undisclosed

    Deal Type: Collaboration June 02, 2025

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    Lead Product(s) : REX-8756

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Preclinical

    Recipient : Recludix Pharma

    Deal Size : $1,325.0 million

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Recludix Names Oral STAT6 Inhibitor Candidate for Inflammatory Diseases with Sanofi

    Details : The collaboration aims to advance preclinical studies, REX-8756, an oral, selective and reversible small molecule inhibitor of STAT6. It is being evaluated for asthma, COPD etc.

    Product Name : REX-8756

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    June 02, 2025

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    Sanofi Completes Acquisition of DR-0201

    Details:

    Sanofi acquired DR-0201, now named SAR448501, a targeted bispecific myeloid cell engager, has shown robust B-cell depletion in pre-clinical and early clinical studies.


    Lead Product(s): SAR448501

    Therapeutic Area: Immunology Brand Name: DR-0201

    Study Phase: Phase IProduct Type: Antibody

    Recipient: Dren Bio

    Deal Size: $1,900.0 million Upfront Cash: $600.0 million

    Deal Type: Acquisition May 27, 2025

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    Sanofi

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    Lead Product(s) : SAR448501

    Therapeutic Area : Immunology

    Highest Development Status : Phase I

    Recipient : Dren Bio

    Deal Size : $1,900.0 million

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Sanofi Completes Acquisition of DR-0201

    Details : Sanofi acquired DR-0201, now named SAR448501, a targeted bispecific myeloid cell engager, has shown robust B-cell depletion in pre-clinical and early clinical studies.

    Product Name : DR-0201

    Product Type : Antibody

    Upfront Cash : $600.0 million

    May 27, 2025

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    C4X Discovery Receives Latest Milestone Payment from Sanofi

    Details:

    Under the licensing agreement, Sanofi is seeking to develop and commercialise an oral therapy for the treatment of inflammatory diseases such as psoriasis, psoriatic arthritis etc.


    Lead Product(s): Undisclosed

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Other Small Molecule

    Recipient: C4X Discovery

    Deal Size: $505.5 million Upfront Cash: $8.3 million

    Deal Type: Licensing Agreement May 27, 2025

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    Sanofi

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    Lead Product(s) : Undisclosed

    Therapeutic Area : Immunology

    Highest Development Status : Preclinical

    Recipient : C4X Discovery

    Deal Size : $505.5 million

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    C4X Discovery Receives Latest Milestone Payment from Sanofi

    Details : Under the licensing agreement, Sanofi is seeking to develop and commercialise an oral therapy for the treatment of inflammatory diseases such as psoriasis, psoriatic arthritis etc.

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : $8.3 million

    May 27, 2025

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    Brand Name : Vaxigrip ® - Adult

    France
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Regulatory Info : Generic

    Registration Country : South Africa

    A/ (h1n1)

    Sanofi

    Dosage Form : INJ

    Brand Name : Vaxigrip ® - Adult

    Dosage Strength : 15mcg

    Packaging : 0.5X1mcg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Brand Name : Vaxigrip ® - Adult

    France
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    Regulatory Info : Generic

    Registration Country : South Africa

    A/ (h1n1)

    Sanofi

    Dosage Form : INJ

    Brand Name : Vaxigrip ® - Adult

    Dosage Strength : 15mcg

    Packaging : 0.5X10mcg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Brand Name : Vaxigrip ® - Paed

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    Regulatory Info : Originator

    Registration Country : South Africa

    A/ (h1n1)

    Sanofi

    Dosage Form : INJ

    Brand Name : Vaxigrip ® - Paed

    Dosage Strength : 15mcg

    Packaging : 0.5X1mcg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Brand Name : Mutagrip

    France
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    Regulatory Info : Originator

    Registration Country : South Africa

    A/ (h1n1)

    Sanofi

    Dosage Form : PFS

    Brand Name : Mutagrip

    Dosage Strength : 15mcg

    Packaging : 1X1mcg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Brand Name : Vaxigrip ® - Tetra

    France
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    Regulatory Info : Generic

    Registration Country : South Africa

    A/ (h1n1)

    Sanofi

    Dosage Form : INJ

    Brand Name : Vaxigrip ® - Tetra

    Dosage Strength : 15mcg

    Packaging : 0.5X1mcg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Brand Name : Vaxigrip ® - Adult

    France
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    Regulatory Info : Generic

    Registration Country : South Africa

    A/ (h3n2)

    Sanofi

    Dosage Form : INJ

    Brand Name : Vaxigrip ® - Adult

    Dosage Strength : 15mcg

    Packaging : 0.5X1mcg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Brand Name : Vaxigrip ® - Adult

    France
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    Regulatory Info : Generic

    Registration Country : South Africa

    A/ (h3n2)

    Sanofi

    Dosage Form : INJ

    Brand Name : Vaxigrip ® - Adult

    Dosage Strength : 15mcg

    Packaging : 0.5X10mcg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Brand Name : Vaxigrip ® - Paed

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    Regulatory Info : Originator

    Registration Country : South Africa

    A/ (h3n2)

    Sanofi

    Dosage Form : INJ

    Brand Name : Vaxigrip ® - Paed

    Dosage Strength : 60mcg

    Packaging : 0.5X1mcg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Brand Name : Vaxigrip ® - Paed

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    Regulatory Info : Originator

    Registration Country : South Africa

    A/ (h3n2)

    Sanofi

    Dosage Form : INJ

    Brand Name : Vaxigrip ® - Paed

    Dosage Strength : 60mcg

    Packaging : 0.5X1mcg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Brand Name : Mutagrip

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    Regulatory Info : Originator

    Registration Country : South Africa

    A/ (h3n2)

    Sanofi

    Dosage Form : PFS

    Brand Name : Mutagrip

    Dosage Strength : 15mcg

    Packaging : 1X1mcg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Brand Name : Abirateron Zentiva

    France
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    Regulatory Info :

    Registration Country : Switzerland

    Abirateroni acetas

    Sanofi

    Dosage Form : Filmtabl

    Dosage Strength : 500mg

    Packaging :

    Brand Name : Abirateron Zentiva

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : Sectral

    France
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    Regulatory Info :

    Registration Country : Italy

    Acebutolol

    Sanofi

    Dosage Form : Acebutololo 400Mg 30 Joined' O...

    Dosage Strength : 30 CPR 400 mg

    Packaging :

    Brand Name : Sectral

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Brand Name : Acetylcysteine Zenti...

    France
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    Regulatory Info :

    Registration Country : Switzerland

    Acetylcystein

    Sanofi

    Dosage Form : Effervescent Tablets

    Dosage Strength : 200mg

    Packaging :

    Brand Name : Acetylcysteine Zentiva

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : Acetylcysteine Zenti...

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    Regulatory Info :

    Registration Country : Switzerland

    Acetylcystein

    Sanofi

    Dosage Form : Effervescent Tablets

    Dosage Strength : 600mg

    Packaging :

    Brand Name : Acetylcysteine Zentiva

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : ASS Cardio Zentiva

    France
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    Regulatory Info :

    Registration Country : Switzerland

    Acetylsalicylic acid

    Sanofi

    Dosage Form : Tablet

    Dosage Strength : 100mg

    Packaging :

    Brand Name : ASS Cardio Zentiva

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : ASS Cardio Zentiva

    France
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    Regulatory Info :

    Registration Country : Switzerland

    Acetylsalicylic acid

    Sanofi

    Dosage Form : Tabl

    Dosage Strength : 100mg

    Packaging :

    Brand Name : ASS Cardio Zentiva

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : Acyclovir Zentiva

    France
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    Regulatory Info :

    Registration Country : Switzerland

    Aciclovir

    Sanofi

    Dosage Form : Cream

    Dosage Strength : 50mg/g

    Packaging :

    Brand Name : Acyclovir Zentiva

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : Acyclovir Zentiva

    France
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    Regulatory Info :

    Registration Country : Switzerland

    Aciclovir

    Sanofi

    Dosage Form : Cream

    Dosage Strength : 50mg/g

    Packaging :

    Brand Name : Acyclovir Zentiva

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : Ibandronat Zentiva O...

    France
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    Regulatory Info :

    Registration Country : Switzerland

    Acidum ibandronicum

    Sanofi

    Dosage Form : Inj L?s

    Dosage Strength : 3mg/3ml

    Packaging :

    Brand Name : Ibandronat Zentiva Osteo

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : Depakine Chrono

    France
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    Regulatory Info :

    Registration Country : Switzerland

    Acidum valproicum; sodium valproas

    Sanofi

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 300mg

    Packaging :

    Brand Name : Depakine Chrono

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    FDA

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    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date :

    Sanofi

    City : Frankfurt Am Main

    State : -

    Country/Area : Germany

    Zip : -

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date :

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    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date :

    Sanofi

    City : Carbon Blanc CEDEX

    State : -

    Country/Area : France

    Zip : -

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date :

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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date :

    Sanofi

    City : Saint Louis

    State : Missouri

    Country/Area : U.S.A

    Zip : 63129

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date :

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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date :

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    City : Malvern

    State : Pennsylvania

    Country/Area : U.S.A

    Zip : 19355

    District :

    Center :

    Project Area : Bioresearch Monitoring

    District Decision : No Action Indicated

    Inspection End Date :

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    FDA Audited

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    District Decision : Voluntary Action Indicated

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    Sanofi

    City : Swiftwater

    State : Pennsylvania

    Country/Area : U.S.A

    Zip : 18370

    District :

    Center :

    Project Area : Vaccines and Allergenic Products

    District Decision : Voluntary Action Indicated

    Inspection End Date :

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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date :

    Sanofi

    City : Chilly Mazarin

    State : -

    Country/Area : France

    Zip : -

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    Project Area : Bioresearch Monitoring

    District Decision : No Action Indicated

    Inspection End Date :

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    07

    FDA Audited

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    Inspection End Date :

    Sanofi

    City : Malvern

    State : Pennsylvania

    Country/Area : U.S.A

    Zip : 19355

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    Project Area : Bioresearch Monitoring

    District Decision : No Action Indicated

    Inspection End Date :

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    08

    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date :

    Sanofi

    City : Aramon

    State : -

    Country/Area : France

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    Project Area : Drug Quality Assurance

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    09

    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date :

    Sanofi

    City : Bridgewater

    State : New Jersey

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    Zip : 08807

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    Project Area : Postmarket Assurance: Devices

    District Decision : Voluntary Action Indicated

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    10

    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date :

    Sanofi

    City : Ploermel

    State : -

    Country/Area : France

    Zip : -

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date :

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