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  • A company that focuses on development of various finished formulations is looking for suppliers of Sucralfate (300 kg) API for commercial purposes. The suppliers must support this enquiry with GMP & CoA.
    28 Mar 2024
    A company that focuses on manufacturing & development of various finished formulations is looking for suppliers of Brivaracetam (5 tons/ 5 years) API for commercial purposes. The suppliers must support this enquiry with COS/CEP & CoA.
    27 Mar 2024
  • A research-based company that focuses on diabetes, oncology, immunology, and other non-communicable diseases is looking for suppliers of Penicillin G Benzathine (13 kg) API for development purposes. The suppliers must support this enquiry with USDMF & CoA.
    27 Mar 2024
    A company that focuses on manufacturing of various high-quality prescription drugs, dietary supplements and dermocosmetics products in response to the needs of patients and the expectations of doctors and pharmacists is looking for suppliers of Food/Pharma Potassium Guaiacolsulfonate API for commercial purposes. The required quantity is MOQ. The suppliers must support this enquiry with ISO, GMP & CoA.
    27 Mar 2024
  • A company that focuses on manufacturing of various high-quality prescription drugs, dietary supplements and dermocosmetics products in response to the needs of patients and the expectations of doctors and pharmacists is looking for suppliers of Food/Pharma Citicoline API for commercial purposes. The required quantity is MOQ. The suppliers must support this enquiry with ISO, GMP & CoA.
    27 Mar 2024
    A research-driven company that focuses on custom synthesis of pharmacopeial & non-pharmacopeial reference standards is looking for suppliers of Cafedrine (100 g - 500 g) API for development purposes. The suppliers must support this enquiry with CoA.
    27 Mar 2024
  • A CDMO that focuses on the development, manufacturing & marketing of niche finished formulations is looking for suppliers of Various RLDs for commercial purposes.
    1. Paclitaxel (100 mg/ ml) Injection - Acopacli Na 100 mg. The required quantity is 1 Unit.
    2. Dasatinib (100 mg) Tablet - Asatinib 100 Mg. The required quantity is 30 Units.
    3. Dasatinib (50 mg) Tablet - Asatinib 50 Mg. The required quantity is 60 Units.
    4. Lenvatinib (4 mg) Capsules - Lentinib 4 mg. The required quantity is 30 Units.
    5. Lenvatinib (10 mg) Capsules - Lentinib 10 mg. The required quantity is 30 Units.
    6. Abiraterone Acetate (250 mg) Tablet - Acobirate 250mg. The required quantity is 120 Units.
    19 Mar 2024
    A company that focuses on manufacturing, development, marketing & distribution of branded and generic FDFs is looking for suppliers of Various Finished Formulations. The supplier must support this enquiry with relevant dossiers.
    1. Mebeverine (200 mg) ER Capsule
    4. Nifedipine (30 mg) ER Capsule
    5. Nifedipine (60 mg) ER Capsule
    6. Nifedipine (90 mg) ER Capsule
    12 Mar 2024
  • A company based in Singapore that focuses on the development, marketing and distribution of a wide range of finished formulations is looking for suppliers of Tretinoin (0.025%) Gel or cream for development purposes. The supplier must support this enquiry with TGA & EU Dossiers.
    11 Mar 2024
    A company based in Singapore that focuses on the development, marketing and distribution of a wide range of finished formulations is looking for suppliers of Adapalene (0.1% & 0.3%) Gel for development purposes. The supplier must support this enquiry with EU Dossier.
    08 Mar 2024
  • A company that focuses on development of innovative prescription products for aesthetic medicine and medical dermatology is looking for CMO to manufacture Liniment for the treatment of Crow’s feet and hyperhidrosis. The required packaging is 1 ml in dropper. The project launch time is in 2026. The required quantity is 10 batches of 100 kg. The country of distribution is United States. The geographical preference for service provider is United States.
    22 Feb 2024
    A company based in United States that focuses providing solutions in areas specifically defense, intelligence, health & bioscience, transport, energy and critical infrastructure is looking for GMP certified CDMO for intravenous injectables. The country of distribution is United States.
    09 Feb 2024
  • A CMO that focuses on manufacturing, licensing & marketing of various OTC & Rx finished formulations is looking for a GMP certified CDMO for Tech Transfer of Solid, Liquid and Semi-Solid finished formulations. The projected annual manufacturing volume is 30 MT – 1000 MT. The country of distribution is Europe & United Kingdom and the geographical preference for service provider is Europe.
    20 Jan 2024
    A company based in India which focuses on providing multiple services under one roof ranging from custom synthesis to trading of novel chemicals, intermediates, nutraceuticals and excipients is looking for CDMO for Spray Drying for Granules. The required packaging is in 50 kg Carboy. The projected annual manufacturing volume is 1500 kg. The country of distribution is the Saudi Arabia and the geographical preference for service provider is India.
    05 Jan 2024
  • A company that focuses on the manufacturing of tablets, capsules, gels & powders is looking for suppliers of Povidone K30 Excipient for commercial purposes. The required quantity is 15 Tons. The supplier must support this enquiry with CoA.
    27 Mar 2024
    A multinational pharmaceutical manufacturing company that has over 200 products covering the whole spectrum of disease areas spanning gastroenterology, oncology, pain management, cardiovascular, dermatology, urology, nephrology, rheumatology, and diabetes is looking for suppliers of Various Excipients for development purposes. The supplier must support this enquiry with CoA.
    1. Capilectine Excipient
    2. Octenidine Dihydrochloride Excipient
    3. Polydextrose Excipient
    15 Mar 2024
  • A company that focuses on research, development, manufacturing and marketing of various pharmaceutical branded and non-branded formulations is looking for suppliers of Polyoxyl 40 Stearate (50 g) Excipient for development purposes. The supplier must support this enquiry with CoA.
    12 Mar 2024
    A company that focuses on manufacturing of various finished formulations of veterinary is looking for suppliers of Lactose Monohydrate (150 mesh & 80 mesh) Excipient for commercial purposes. The required quantity is 6,000 kg. The supplier must support this enquiry with CoA.
    08 Mar 2024

Interviews #SpeakPharma

  • “LGM operates as a trusted partner by seeking out optimal source of APIs for clients”
    This week, SpeakPharma interviews Selwyn Lustman, Senior Vice President, Global Sourcing and Procurement, LGM Pharma, a tailored active pharmaceutical ingredient (API) and contract development and manufacturing services provider (CDMO) for the full drug product lifecycle. Lustman discusses the kind of regulatory support LGM provides its clients, while also talking about its methodology for selecting the optimum source of APIs for its clients. Excerpts:Can you briefly take us through the history of LGM Pharma?We were established in 2005, and since inception we have been on a dedicated mission to excel in the sourcing and distribution of top-tier APIs, offering comprehensive API supply chain solutions spanning R&D to commercialization.In 2020, LGM Pharma acquired the formulation development and drug product manufacturing business of Nexgen Pharma, Inc. This acquisition merged LGM’s global leadership in API sourcing, distribution, and supply chain management with Nexgen Pharma’s comprehensive drug product CDMO services.What are some of the risks involved in sourcing APIs? And how can drugmakers manage these risks?The primary challenges associated with API sourcing encompasses quality and regulatory considerations, necessitating the assurance of a material source aligned with the specific quality and regulatory standards applicable to the ultimate dosage product launch.Efficient supply chain distribution hinges on establishing a collaborative partnership with a manufacturer capable of seamlessly supporting the entire spectrum, from early research and development (R&D) stages to the culmination of full-scale commercialization.Price considerations also come to the fore, demanding that the chosen manufacturer not only meets but surpasses safety, environmental, and health requirements. Working with a seasoned sourcing partner serves as a proactive measure to mitigate these risks, as such a partner brings forth invaluable expertise to navigate the intricate landscape of regulatory and quality guidelines.What kind of regulatory support do you provide your clients?LGM Pharma offers a comprehensive suite of regulatory expertise to its clients, encompassing a spectrum of critical services. This includes evaluation of active substances and the meticulous technical writing and compilation of US Drug Master Files.Throughout the development process, LGM provides expert regulatory CMC (chemistry, manufacturing and controls) compliance guidance, overseeing the writing and assessment of quality/CMC regulatory documents (Module 2 and 3).LGM Pharma ensures seamless coordination with clinical trial partners to guarantee eCTD (electronic common technical document) compliance (Module 5) and conducts critical writing and reviews of drug substance and drug product documentation.LGM’s commitment extends to adherence to Code of Federal Regulations and guidance documents, ensuring the timely approval of new abbreviated new drug applications (ANDAs), amendments, and post-approval changes.LGM Pharma also exhibits agility in responding to inspection requests (IRs) and commitment resolutions (CRs) prior to due dates, engages in regulatory authority interactions, including serving as a US agent, and conducts regulatory compliance gap analyses with adept issue resolution. Additionally, LGM conducts scientific, regulatory, and due diligence review of regulatory documents and submissions, reinforcing its commitment to regulatory excellence.LGM Pharma has a strategic approach to API sourcing. Can you throw some light on this approach, and its benefits to your clients?LGM Pharma distinguishes itself from conventional distributors by adopting a unique approach – one that sets it apart in the industry. Unlike distributors aligned with specific API manufacturers, LGM takes on a consultative role, prioritizing the representation of its clients’ interests.Operating as a trusted advisor, LGM actively seeks out the optimal source of API for clients to serve as their primary drug substance supplier. In contrast to distributors affiliated with particular manufacturers, who inherently advocate for their associated companies, LGM positions itself as an unbiased entity capable of objectively confirming the selection of the best manufacturer. This client-centric approach ensures a discerning and tailored choice in the dynamic landscape of pharmaceutical ingredient sourcing.What role does logistics play in API sourcing? How does LGM Pharma help out its clients with regulatory compliance?Logistics plays a critical role in API sourcing, influencing the efficiency, reliability, and regulatory compliance of the supply chain. LGM Pharma, as a specialized pharmaceutical ingredient supplier addresses these logistics challenges in the following ways:- Supply chain management: LGM is involved in managing the end-to-end supply chain, ensuring the timely and secure movement of APIs from manufacturers to clients. This involves coordinating transportation, handling custom clearance, and optimizing inventory levels to prevent disruptions to the supply chain. - Quality assurance in transportation: Given the sensitivity of pharmaceutical APIs, LGM implements stringent quality assurance measures during transportation to maintain the integrity of the APIs. - Regulatory compliance: LGM assists clients in navigating the complex regulatory landscape associated with API sourcing. This includes adherence to GMP regulations, compliance with international standards, and ensuring that the transportation and storage of APIs meet regulatory requirements. - Documentation and record keeping: LGM maintains detailed documentation related to the transportation and handling of APIs, facilitating regulatory audits and compliance checks. Accurate record-keeping is essential for demonstrating compliance with regulatory guidelines. 

    Impressions: 2476

    https://www.pharmacompass.com/speak-pharma/lgm-operates-as-a-trusted-partner-by-seeking-out-optimal-source-of-apis-for-clients

    13 Dec 2023

Data Compilation & Company Tracker #PharmaFlow

  • FDA approves four oligonucleotide therapies in 2023; Novartis, GSK, Novo bet big
    In the intricate world of molecular biology, oligonucleotides stand out as versatile, powerful molecules. Oligonucleotides are essentially short, single strands of DNA or RNA that modulate gene expression. There are various oligonucleotide therapy (ONT) agents (such as antisense, deoxyribozymes, siRNA and CRISPR/Cas) that offer promising therapeutic tools.A variation of gene therapy, oligonucleotide gene therapies (OGTs) are manufactured using synthetic oligonucleotides. These therapies are designed to enter cells. ONTs act like tools that can fine-tune the behavior of certain genetic instructions, and are therefore often designed to treat rare and genetic diseases and cancers. Sometimes, they may be delivered into cells through lipid nanoparticles or adeno-associated viruses (AAV), halting the translation of a specific protein. Oligonucleotides have also revolutionized vaccine development through the creation of nucleic acid vaccines, such as mRNA vaccines.The first oligonucleotide drug, known as fomivirsen, was approved by the US Food and Drug Administration (FDA) back in 1998. It was developed by Ionis Pharmaceuticals (then known as Isis Pharmaceuticals), and was approved to treat a rare eye disease. However, ONT approvals have picked up since 2016. Currently, there are 20 oligonucleotide drugs approved by the FDA and the European Medicines Agency (EMA) and a majority of them treat orphan and rare diseases.In 2023, FDA approved four ONTs — AstraZeneca-Ionis’ Wainua (eplontersen), Novo Nordisk owned Dicerna Pharmaceuticals’ Rivfloza (nedosiran), Biogen-Ionis’ Qalsody (tofersen) and Iveric Bio’s Izervay (avacincaptad pegol).In 2021, the global ONT market size was estimated to be US$ 18.2 billion. It is expected to increase to US$ 51.4 billion by 2029, growing at a compounded annual rate (CAGR) of 13.85 percent. Similarly, the market for oligonucleotides synthesis (or the process of producing oligonucleotides) was estimated at US$ 7.7 billion globally in 2022 and is expected to grow 11.8 percent CAGR to reach US$ 16.4 billion by 2030. Some of the bigger players in oligonucleotides synthesis are Danaher Corporation, Thermo Fisher Scientific, Merck KGaA, Eurofins, Agilent, Bio-Synthesis, EUROAPI, Eurogentec, STA Pharma, and Bachem.View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available)ONTs address neuro disorders; four ONTs bring in US$ 1.24 bn for AlnylamONTs are widely applied to treat neurodegenerative diseases, such as Duchenne muscular dystrophy (DMD). Multiple ONTs have been approved in Europe and the US for DMD, such as Exondys 51 (eteplirsen), Vyondys 53 (golodirsen), and Amondys 45 (casimersen) from Sarepta and NS Pharma’s Viltepso (viltolarsen). Last year, Ionis bagged two approvals in the space. FDA approved its Biogen-partnered therapy Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS). The agency also approved AstraZeneca and Ionis’ drug Wainua (eplontersen), rendering it as the first self-administered treatment for a rare nerve damage disease, known as hereditary transthyretin amyloidosis (ATTR-PN). Analysts estimate global peak sales for Wainua to come in at US$ 750 million for ATTR-PN alone. The drug is also being tested for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), a rare heart muscle disorder.Alnylam Pharmaceuticals has also successfully brought four ONTs to market in recent years — Onpattro (patisiran) and Amvuttra (vutrisiran) for rare nerve diseases, and Givlaari (givosiran) and Oxlumo (lumasiran). Givlaari has been approved to treat acute hepatic porphyria (a liver enzyme deficiency) while Oxlumo treats primary hyperoxaluria (a disorder characterized by increased urinary oxalate excretion). The four ONTs brought in US$ 1.24 billion for Alnylam in 2023.View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available) Novartis buys rights to siRNA therapy, GSK bets big on ONT pipeline through dealsAfter Alnylam discovered inclisiran (Leqvio), Novartis acquired global rights to the therapy in a US$ 9.7 billion deal. Leqvio was the first FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction. It brought in US$ 355 million for Novartis in 2023.GSK has increasingly been investing in its ONT pipeline. The British pharma has promised over US$ 5 billion in upfront and milestone payments in multiple deals. In February, GSK exercised its option to license Elsie Biotechnologies’ discovery platform to find and develop novel ONTs. GSK has also entered a discovery collaboration with Wave Life Sciences.Last July, Japanese drugmaker Astellas Pharma completed its approximately US$ 5.9 billion buyout of New Jersey-headquartered Iveric Bio. Iveric focuses on retinal diseases and the deal gives Astellas drug candidates to treat about 160 million people with eye ailments. Subsequently, in August, Iveric’s Izervay (avacincaptad pegol) was approved by the FDA as a new treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).After Novo Nordisk acquired RNAi technology company Dicerna Pharmaceuticals for US$ 3.3 billion in 2021, the latter’s once-monthly RNAi therapy Rivfloza (nedosiran) saw FDA approval last October. Rivfloza was okayed for children nine years and older to treat a rare genetic condition that affects the kidneys, known as primary hyperoxaluria type 1 (PH1).View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available) Ionis tees up NDAs for rare disease treatments after two late-stage trial winsThe industry is looking for cures to a wide spectrum of diseases like cancer (such as melanoma, pancreatic, liver, glioblastoma, breast and ovarian cancer), cystic fibrosis, Alzheimer’s disease, Parkinson’s disease, hepatitis B, asthma, Rett syndrome, non-alcoholic steatohepatitis, and IgA nephropathy through its research on ONTs.In January, Ionis announced late-stage results wherein its RNA-targeted hereditary angioedema (HAE) candidate, donidalorsen, significantly reduced the rate of HAE attacks in patients treated every four weeks and patients treated every eight weeks. The California-based biotech is readying a new drug application (NDA) to submit to the FDA. HAE is a rare and life-threatening genetic disease that causes unpredictable and frequent severe swelling of the skin, gastrointestinal (GI) tract, upper respiratory system, face and throat. This year, Ionis’ olezarsen was granted fast track designation by the FDA for the rare genetic disease familial chylomicronemia syndrome (FCS). Last September, olezarsen had met its primary endpoint of reducing abnormally high levels of triglycerides in a late-stage trial in patients with the metabolic disorder. Currently, there are no FDA-approved treatments for this condition. If okayed, olezarsen is likely to bring in US $849 million in sales for Ionis by 2032.In March, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to two in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent (TD) anemia in certain adult patients with myelodysplastic syndromes. The agency assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2024, for Geron’s NDA for imetelstat. It is among the most anticipated drug launches this year.View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available) Our viewDeveloping ONTs is a field fraught with challenges, such as toxicity and drug delivery. There are safety concerns as well as concerns around delivering the therapy. However, technological breakthroughs and collaborations between pharma firms and contract research organizations that focus on drug delivery are continuously working towards addressing these challenges. All in all, we foresee exciting times ahead for ONTs.  

    Impressions: 746

    https://www.pharmacompass.com/radio-compass-blog/fda-approves-four-oligonucleotide-therapies-in-2023-novartis-gsk-novo-bet-big

    #PharmaFlow by PharmaCompass
    21 Mar 2024

Monthly Stock Recap #PipelineProspector

  • Pipeline Prospector Feb 2024: Novo’s parent buys Catalent for US$ 16.5 bn, FDA okays Iovance’s cell therapy
    February was a good month for the pharma sector, complete with some important deals, successes from clinical trials and healthy fourth quarter (Q4) results announced by some drugmakers. The market cheered the good news — the Nasdaq Biotechnology index gained 1 percent from 4,385.06 to 4,428.56, the SPDR S&P Biotech ETF index spiked 12 percent to 98.42 after ending January at 87.43. The S&P Biotechnology Select Industry Index (SPSIBI) soared 16 percent from 6,815.3 to 7,896.47 in February.The month saw some big acquisitions. Novo Holdings, the parent company of Novo Nordisk, acquired contract development and manufacturing organization (CDMO) Catalent for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. Novo’s game plan hasn’t gone down well with its arch rival in the diabetes and obesity segment Eli Lilly. The Indianapolis-headquartered drugmaker has called for a scrutiny of the deal as it relies on Catalent for some of its diabetes and obesity drugs that compete with Novo’s meds.Both Novo and Lilly have been struggling to meet the demand for their weight loss meds. With the acquisition of this key CDMO, Novo has scored an edge over competition.Meanwhile, Gilead boosted its liver portfolio with the US$ 4.3 billion acquisition of CymaBay Therapeutics. And Novartis announced the acquisition of cancer treatment developer MorphoSys for € 2.7 billion (US$ 2.9 billion). With this buyout, Novartis gets a late-stage, rare bone-marrow cancer treatment — pelabresib — that holds plenty of promise.Several drugmakers announced their Q4 results last month. Notable amongst them was Eli Lilly, as it posted a 28 percent increase in revenues — from US$ 7.3 billion in Q4 2022 to US$ 9.4 billion led by its new products Mounjaro and Zepbound. GSK touted the “exceptional launch of Arexvy”, the world`s first RSV vaccine, as it brought in sales of £ 1.2 billion (US$ 1.52 billion) in 2023. And Merck’s Keytruda saw a 19 percent increase in its sales in 2023 — at US$ 25 billion.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel)FDA okays Iovance’s T-cell therapy; Roche’s asthma med okayed for food allergiesThe US Food and Drug Administration (FDA) granted accelerated approval to Iovance Biotherapeutics’ cell therapy — Amtagvi (lifileucel) — for treating the deadliest form of skin cancer. Amtagvi is the first and only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer. Iovance hopes to start reporting noteworthy revenue in the second quarter of 2024, despite the fact that Amtagvi comes with a boxed warning (the highest safety warning) for treatment-related mortality. FDA also approved Takeda’s Eohilia as the first oral treatment for an allergic inflammation of the esophagus. Eohilia (budesonide oral suspension) was on course to becoming the first treatment for eosinophilic esophagitis (EoE) until it was rejected by the FDA in December 2021.In January, Sanofi and Regeneron’s jab Dupixent had pipped Eohilia to become the first FDA drug approved for EoE. The chronic condition can make it very hard for patients to consume food. Dupixent (dupilumab) is injected weekly or biweekly and two pens cost US$ 3,803.20. In contrast, Takeda’s drug is taken twice daily and costs US$ 1,875 per month.Roche and Novartis’ asthma drug Xolair (omalizumab) became the first FDA-approved med to help people with food allergies avoid severe reactions following accidental exposure. This opens the drug to around 17 million people in the US whose allergies can potentially be deadly.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) Boehringer’s obesity candidate, Lilly’s tirzepatide show promise in trials for MASHBoehringer Ingelheim announced promising phase 2 trial data for its experimental obesity drug survodutide in treating metabolic dysfunction-associated steatohepatitis (MASH), a liver disease. The drug is being developed in collaboration with Zealand Pharma. It had received a fast-track designation from the FDA in June 2021. MASH causes histologic liver damage and occurs in patients who are not alcoholics and who are often obese or have type 2 diabetes.The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks. Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. The companies said this potentially positions it as a “best-in-class” treatment. The drug belongs to the glucagon-like peptide 1 (GLP-1) class of drugs.In another trial, Eli Lilly announced positive results from a phase 2 study of tirzepatide in adults with MASH — 74 percent of participants were cured of MASH and their fibrosis also did not worsen at 52 weeks (as compared to nearly 13 percent for participants in the placebo group).Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) J&J’s autoimmune drug posts trial gains; Sanofi’s frexalimab shows benefit in MSOne of Johnson & Johnson’s most watched experimental drugs — nipocalimab — posted positive results in trials for the treatment of two autoimmune disorders. In a phase 3 study, nipocalimab significantly reduced symptoms of generalized myasthenia gravis (GMG). And, in a phase 2 study, it helped reduce the severity of Sjögren’s disease (SjD). GMG weakens the skeletal muscles and particularly affects control of the limbs, throat, mouth, and eyes. SjD is an immune disorder that is identified by symptoms like dry eyes and dry mouth. J&J expects over US$ 5 billion from this drug. In a phase 2 trial, Sanofi’s frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis (MS). In December last year, the French multinational had named frexalimab as one of three “pipeline-in-a-product” assets with the potential of generating annual peak sales in excess of €5 billion (US$ 5.4 billion). The phase 2 results give credence to those expectations.In trial failures, Gilead (stock down 8 percent) said the FDA has paused all trials of its drug magrolimab in the treatment of two blood cancers – acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) – because of increased risk of patient death (when used in combination with azacitidine plus venetoclax). Magrolimab was the lead candidate of Gilead’s US$ 4.9 billion acquisition of Forty Seven in 2020.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) Our viewThe year has gotten off to a good start with drugmakers posting healthy Q4 results and the indices showing some positive growth month-on-month. Several drugmakers have entered 2024 with a simplified business model and an increased strategic focus on R&D. Given the favorable demand, we are hopeful of a better year for the industry, as opposed to the volatility of the last two years.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) 

    Impressions: 1166

    https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-feb-2024-novo-s-parent-buys-catalent-for-us-16-5-bn-fda-okays-iovance-s-cell-therapy

    PharmaCompass.com
    07 Mar 2024

Weekly News Recap #Phispers

  • Madrigal’s Rezdiffra becomes first FDA-approved drug to treat NASH; Astra buys Fusion for US$ 2.4 bn
    It was a week of drug approvals, as the US Food and Drug Administration (FDA) okayed several therapies before the close of the first quarter of 2024.For quite some time, the drug development field for the liver condition non-alcoholic steatohepatitis (NASH) has been a graveyard for failed programs. This week, the field celebrated a hurrah moment when Madrigal Pharmaceuticals won the race to have the first NASH treatment approved by the FDA.After nearly 40 years, FDA approved a new therapeutic pathway for hypertension. Idorsia’s Tryvio is a once-daily med for hypertension that is to be used in combination with other BP drugs by people who are not able to adequately control their BP on other drugs.FDA has also granted the chimeric antigen receptor (CAR) T-cell therapy Breyanzi accelerated approval for two types of hard-to-treat blood cancers and its oncology panel has ruled favorably on Johnson & Johnson’s Carvykti and Bristol Myers Squibb’s Abcema.Orchard Therapeutics’ Lenmeldy has secured FDA approval to become the first gene therapy in the US for a rare pediatric disorder – metachromatic leukodystrophy (MLD). The agency also approved Optinose’s Xhance —the first medicine to treat chronic sinusitis.In deals, AstraZeneca bought two companies, shoring up its cancer and rare disease pipelines. The Anglo-Swedish drugmaker first bought France’s Amolyt, which focuses on rare endocrine diseases, for a total of US$ 1.05 billion and then acquired next-generation cancer drugmaker Fusion Pharmaceuticals for around US$ 2 billion. Meanwhile, Pfizer said it intends to cut its stake in Haleon from 32 percent to 24 percent.Madrigal’s Rezdiffra becomes first FDA-approved drug for liver disease NASHMadrigal’s oral drug Rezdiffra (resmetirom) has become the first treatment in the US for adults with the common fatty liver disease — NASH. Also known as MASH (metabolic dysfunction-associated steatohepatitis), the disease causes histologic liver damage and occurs in patients who are not alcoholics and are often obese or have type 2 diabetes. The approval has opened a multi-billion dollar opportunity for Madrigal.After a year of Rezdiffra, liver biopsies showed more subjects achieved NASH resolution or an improvement in liver scarring as compared to those on the placebo. The annual wholesale price of Rezdiffra is US$ 47,400. Rezdiffra had received breakthrough therapy designation last April. The American Liver Foundation CEO Lorraine Stiehl called the approval a “game-changing” moment.Astra to buy next-generation cancer drugmaker Fusion for up to US$ 2.4 bnAstraZeneca has agreed to buy clinical-stage biopharma Fusion Pharmaceuticals for US$ 2.4 billion. According to a company statement, the acquisition marks a major step forward for Astra, as it gains foothold into radioconjugates (RCs) — a promising modality in cancer treatment.Boosts rare-disease pipeline with Amolyt buyout: Astra also agreed to buy France’s Amolyt, which focuses on rare endocrine diseases, for a total value of US$ 1.05 billion. Amolyt’s pipeline includes a late-stage asset — eneboparatide (AZP-3601) — with the potential to address a significant unmet need in patients with chronic hypoparathyroidism.Pfizer to slash stake in Haleon to 24 percent: Pfizer, which is currently the largest shareholder in the world’s biggest standalone consumer health company — Haleon, is reducing its stake from 32 percent to 24 percent. Haleon makes household brands like Panadol, Advil, and Sensodyne. The New York-based drug behemoth is set to offload 630 million Haleon shares, which was worth about £ 2.03 billion (US$ 2.58 billion), going by the stock’s closing price on March 15.FDA okays Idorsia’s once-daily antihypertensive drug TryvioFDA has approved Idorsia’s once-daily treatment Tryvio (aprocitentan) for hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not able to adequately control their BP on other drugs. Tryvio is the first oral anti-hypertensive therapy, which works via a new therapeutic pathway, to be approved in almost 40 years. Idorsia expects millions of patients in the US to benefit from it.BMS’ Breyanzi becomes first CAR-T therapy for hard-to-treat blood cancersFDA has granted accelerated approval to BMS’ Breyanzi making it the first and only CAR-T cell therapy for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Breyanzi is a personalized one-time treatment where a patient’s own white blood cells are engineered to better target and destroy malignant “B cells”. In a mid-stage trial, Breyanzi demonstrated a response in 45 percent of patients and achieved a complete response in 20 percent of patients. This reportedly makes it an effective option for patients who have relapsed after receiving targeted therapies.FDA panel backs expanded use of J&J, BMS’ CAR-T therapies: FDA’s Oncologic Drugs Advisory Committee voted unanimously (11-0) that the benefits of J&J and Legend’s Carvykti outweigh its risk in earlier lines of multiple myeloma treatment. Similarly eight of the committee’s members voted in favor of BMS and 2seventy bio’s Abcema. They said it demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma.Takeda’s Iclusig wins accelerated nod: FDA has granted accelerated approval to Takeda’s Iclusig (ponatinib) to be used with chemotherapy for newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), a type of blood cancer of the bone marrow and blood. This makes it the only targeted therapy approved as a first line of treatment for the condition in the US.FDA okays Orchard’s Lenmeldy as first gene therapy for rare pediatric disorderOrchard Therapeutics’ Lenmeldy has secured FDA approval to become the first gene therapy in the US for a rare pediatric disorder, known as metachromatic leukodystrophy (MLD). The agency indicated it for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile MLD. The debilitating hereditary disease affects the brain and nervous system and causes loss of cognitive and motor function and early death.FDA okays drug to treat chronic sinusitis: FDA has approved the first medicine to treat chronic sinusitis, which affects about 30 million adults in the US. The nasal spray Xhance (fluticasone propionate) uses an exhalation delivery system to deposit a topical steroid in target areas of inflammation deep in the nose not typically reached by standard nasal sprays, its maker Optinose said.BeiGene’s Tevimbra bags nod for advanced esophageal cancer: BeiGene’s PD-1 blocker Tevimbra (tislelizumab) has finally got the go ahead from the FDA as the treatment for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.  

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    21 Mar 2024

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  • View Sharp`s clinical trial supply & contract pharmaceutical packaging services for injectables and oral dosage forms on PharmaCompass.
    View Sharp`s clinical trial supply & contract pharmaceutical packaging services for injectables and oral dosage forms on PharmaCompass. What is pharmaceutical contract packaging and how is Sharp a reliable packaging partner for the pharmaceutical and biotech industries? Pharmaceutical packaging can be defined as a set of operations including filling, sealing, packaging, and labeling of semi-finished or finished products. Pharma packaging is an economical means to present, preserve, identify, provide information, maintain product integrity, and ensure stability. It also plays a crucial role in the transportation of sensitive and strictly controlled products. Pharmaceutical contract packaging refers to packaging that is executed and supplied by a licensed third-party service provider that comprises both initial packaging and repackaging. These contract packaging service providers may offer clinical and commercial packaging solutions for pharmaceutical products. Pharmaceutical contract packaging organizations are well-equipped to offer a comprehensive range of primary, secondary, and tertiary packaging solutions. Primary packaging surrounds the pharmaceutical formulation and includes bottles, blisterings, pouches, sachets, tubes, auto-injector pens, etc. Whereas secondary packaging offers further external protection and includes artwork design, labeling for parenteral and injectables, child-resistant and compliance prompting packaging, etc. Additionally, tertiary packaging is used during transportation to absorb physical impacts, moisture, and dust and includes cardboard boxes, stretch wraps, shrink films, and wooden and plastic pallets. Sharp is a leading contract packaging organizations that offer pharmaceutical packaging services among others. It has more than 70 years of experience in pharmaceutical clinical packaging, clinical trial supply services, and small-scale sterile manufacturing. Sharp has more than 2,000 employees who work in its state-of-the-art GMP facilities in the US, UK, Belgium, and the Netherlands. Sharp, offers contract manufacturing and packaging services and support from phase I clinical trial supplies to commercial launch and lifecycle management to its pharmaceutical and biotechnology partners across the world. It has deep expertise in clinical trial packaging and labeling along with a skilled global design team that utilizes cutting-edge software and technology ensuring patient-friendly and differentiated packaging for drug products. Apart from this, Sharp is also a reliable partner for sourcing packaging material and offers integrated pharmaceutical packaging and labeling services along with over-encapsulation of oral solids and the production of placebo capsules for study blinding. Sharp is a contract packaging organization that offers commercial packaging services including contract blister packaging services, bottle packaging, sachet packaging, injectable packaging, and other solid dose packaging solutions. Additionally, it offers clinical packaging and labeling solutions such as clinical trial material packaging, clinical trial packaging and labeling, clinical trial logistics and packaging, and clinical trial supply services, or clinical supplies. Its clinical and commercial packaging services are outlined below: Clinical Packaging Solutions Sharps clinical packaging solutions encompass primary packaging and labeling and secondary packaging. Its pharmaceutical primary packaging offers reliable clinical packaging services, clinical supply chain services, primary packaging solutions, and cold-chain secondary packaging and labeling at 2-8°C, -20°C, and even at -70°C. Sharp also provides reliable clinical pharma packaging services and labeling, secondary packaging solutions, pharmaceutical clinical packaging and labeling solutions along with expertise and capabilities in handling cold-chain pharmaceutical labeling and packaging from 2-8°C to -70°C. Commercial Packaging Solutions For more than 65 years, Sharp has been providing a full range of commercial primary and secondary packaging solutions, blister packaging, and contract manufacturing and packaging services for pharmaceutical oral solid dosage forms. It offers contract blister packaging services and bottle packaging for pharmaceutical drug products. Apart from this Sharp provides pharma packaging contract services for small and large-volume batch sizes of injectables. It offers pharmaceutical packaging services for cold chain storage, packaging in temperature- and light-controlled environments, serialization, and customized distribution. Additionally, Sharp is involved in the pharma packaging of oral solids, liquids, and semi-solids. Moreover, Sharp is a premier commercial packaging service provider for high-value, low-volume gene therapy. It also offers pharmaceutical packaging services, expertise, and powerful technology that facilitates product serialization and aggregation. Therefore, Sharp’s pharma packaging contract services, spanning from clinical supplies to commercial include pharma clinical trial material manufacturing, clinical primary packaging services, clinical secondary packaging solutions, clinical trial packaging and labeling, and clinical trial logistics and packaging. Furthermore, Sharp’s contract manufacturing and packaging services encompass commercial pharma packaging solutions and labeling and supply services. Consequently, all the aforementioned offerings position Sharp as a one-stop-shop contract pharmaceutical packaging service provider for clinical and commercial scales. How does Sharp address challenges related to clinical labeling and secondary packaging? Sharp has over 70 years of experience and is a pioneer in clinical trial supply services and pharmaceutical packaging. Dedicated to the right-first-time principle, Sharp is a reliable partner for secondary packaging and clinical pharmaceutical labeling and packaging. It offers a wide range of quick, scalable clinical trial packaging services and labeling and packaging solutions in all formats, with capabilities spanning the complete lifespan of investigational medicinal products (IMPs). Moreover, Sharp can also address challenges related to packaging and labeling and offers pharmaceutical packaging and labeling services and clinical packaging and labeling services to its clients. Additionally, its clinical packaging and labeling solutions also include in-house auxiliary variable data printing outsourced booklet labels; client-supplied randomization fully supported; and annex 13 compliant and 21 CFR Part 11 compliant PRISYM software for label design. Sharp's pharmaceutical packaging and labeling services include single and multi-panel labels and booklets; 2D barcoding capabilities, randomized and open; 128 barcoding. It also offers; regulatory and translation services; sequentially numbered, variable text; code break, and randomized generation among other clinical packaging and labeling solutions. Sharp is a leader in providing pharmaceutical clinical packaging, contract packaging services, and labeling and supply services in compliance with strict regulatory guidelines. It has special pharma packaging and labeling expertise and capabilities for packaging drug products. Sharp addresses various challenges related to pharma packaging and labeling which includes: Sharp can provide cold-chain pharmaceutical labeling and packaging from 2-8°C to -70°C for drug products that need low temperatures for their transportation and storage. Sharp can support the secondary packaging for most complex drug candidates, such as controlled substance packaging (DEA schedule I-V), and has the capabilities to scale up to commercial supplies. Its design and logistics staff can also assist with the challenges of blinding products and syringes for clinical trial services. Sharp does this by providing annex 13 compliant and 21 CFR Part 11 compliant PRISYM software for label design, client-supplied randomization fully supported, and in-house auxiliary variable data printing outsourced booklet labels. With issues related to timely delivery and efficient labeling, Sharp provides pharmaceutical labeling and packaging solutions by using Scan assembly technology and Interactive Response Technologies (IRT), storage, and distribution. To overcome the label readability issues for clients worldwide, Sharp designs and prints multilingual clinical labels. Therefore, Sharp acts as a one-stop-shop packaging organization that provides pharmaceutical contract packaging services, clinical primary packaging services, primary and secondary clinical packaging, and labeling and supply services to its clients worldwide. What range of packaging design and kitting services does Sharp offer? Sharp is a market leader in the design and delivery of primary and secondary packaging. Due to its structural, graphic, and design engineers as well as its understanding of supply chain and regulatory issues, Sharp excels in pharmaceutical packaging. Sharp has years of experience in creating cutting-edge pharma packaging solutions. It is skilled in brand creation, modifying current artwork, marketing research, FDA filing standards, 3D rendering, senior, child-friendly, or child-resistant design, and labeling and supply services. Sharp's global design team provides the creativity and accuracy required to design highly functional and compliant primary and secondary commercial and clinical pharma packaging services. Sharp offers a wide range of design services and pharmaceutical packaging solutions using the latest tools and technologies to guarantee premium and user-friendly product packaging. Additionally, it provides structural and graphic design development for quick launch and regular upgrades for commercial artwork. Sharp’s wide range of packaging design services for pharmaceutical products includes: Artwork Design Services: Sharp can provide pharma packaging contract services including customized artwork as per specific markets from initial mock-ups to product registration. Packaging Samples: Sharp’s contract pharmaceutical packaging services can create production-quality models for use in marketing presentations, human factor research, and photography that closely match the commercial package. Tray Design: Sharp precisely assesses product components to create a tray design that best suits the drug. 3D Printing: Sharp can rapidly confirm that all product components fit by using its technology to create 3D printed prototypes of trays and other packaging component designs. Shipper and Pallet Design: The structural designers at Sharp develop pallet layouts and shippers based on finished items to guarantee drug safety during distribution and storage. CR/SF Compliant Design and Testing: Sharp offers pharmaceutical contract packaging services and can determine the level of toxicity in child-friendly packaging. Various structural design services offered by Sharp include end-user interactions and compliance; child-resistant, senior-friendly (CR/SF) design; tamper evident features; multiple-component kitting requirements; and sustainable or specified materials. Additionally, Sharp’s graphic design capabilities include serialization artwork; brand identity; complete package graphics; product and package illustrations; and late-stage customization. Sharp’s broad range of tailored kitting options for medical devices, pharmaceuticals, and biotechnology calls for the packaging of multiple components into a single, self-contained unit. The design team at Sharp offers commercial packaging solutions and helps clients create a kit that best meets the end-user needs and product specifications. Its kitting services include labeling, tray packing, and boxing with comprehensive verification inspection to ensure the highest level of quality. How does Sharp manage the packaging of sterile formulations to ensure product integrity? Sharp has almost seven decades of packaging experience and it provides pharmaceutical packaging solutions for sterile and non-sterile formulations while maintaining the integrity and quality of products. It offers contract pharmaceutical packaging services and package design services from its US and EU facilities for injectables containing both small and large-volume batch sizes. For product launch and sample programs, its international design team works with clients to provide pharma packaging solutions and determine the optimal vial, prefilled syringe, and autoinjector packaging options. Through its partnership with Berkshire Sterile Manufacturing (BSM), Sharp also offers small-scale isolator-based sterile fill-finish options. It specializes in pharmaceutical clinical packaging and commercial packaging in cold chain storage, packaging in temperature and light-controlled environments, and specialty distribution for injectable drug products.  It also supports multi-country launches from the US and EU. Sharp has experience in parenteral and injectable format labeling and packaging such as vials, autoinjectors, syringes, and pens. Its specialized commercial and clinical services for injectables and parenterals include primary and secondary labeling of vials, IV bags, pre-filled syringes, and IV bottles in ambient, cold and ultra-cold environments; custom label generation; kitting; serialization and aggregation; and storage and distribution. Some of Sharp’s sterile packaging capabilities for injectable drug products include: Vial Labeling and Packaging: Sharp has decades of packaging experience and offers pharmaceutical packaging and labeling services for vials. Its contract packaging services include an automated visual inspection of labeling, tray and carton packing, cartoning of single and multipacks, tamper-evident solutions, cold-chain storage (2-8°C), and ultra-low temperature freezer banks (-20°C/-70°C). In addition to these services, Sharp provides package design; kitting; and segregated suites to handle highly potent APIs (HPAPI), cytotoxins, hormones; serialization and aggregation; and specialty distribution. Autoinjector and Pen Assembly, Labeling, and Packaging: Sharp excels in managing the complexities related to autoinjector or pen device labeling and packaging from its US and EU facilities. Moreover, its YpsoMate autoinjector device delivers a high level of technical accuracy required for the assembly of prefilled syringes into YpsoMate autoinjectors. Sharp’s experts also offer clinical trial packaging services and specialize in managing the challenges related to clinical trial logistics and packaging of biological formulations. Pre-Filled Syringe Assembly, Labeling, and Packaging: Sharp is a leader in the assembly, labeling, and packaging of pre-filled syringes and safety devices. It provides customized commercial and clinical pharma packaging services for both small and large-volume batch sizes for injectables. Small Scale Sterile Fill-Finish: Sharp partners with Berkshire Sterile Manufacturing (BSM) and offers high-quality, manufacturing, packaging, and distribution solutions for flexible fillers, BSM fills vials, cartridges, syringes, and lyophilization. Gene Therapy Clinical and Commercial Packaging: Sharp has over 70 years of experience in packaging complex pharmaceuticals such as low-volume, high-value gene therapies. Sharp is also engineered to provide demand-led supply commercial and clinical services including batch sizes as small as 1 vial, or packaging, labeling, and distribution in cold, ultra-cold, or cryogenic conditions. Sharp also has dedicated facilities in Bethlehem, PA, US, Heerenveen, and the Netherlands for handling gene therapies. These facilities are equipped with HEPA air handling systems; controlled temperature; humidity and dew point; full-sized -80°C freezer banks in dedicated production suites; constant monitoring of time-out-of-refrigeration, and specific freeze-thaw cycles. These facilities help in providing clinical trial packaging services and clinical secondary packaging solutions along with commercial packaging of sterile formulations. What range of pharmaceutical packaging solutions does Sharp offer for solid and liquid drug products? With a history spanning more than 70 years, Sharp is a pioneer in providing pharmaceutical packaging services that include primary and secondary packaging of solid, liquid, and semi-solid drug products for clinical and commercial scales from its state-of-the-art facilities. Sharp offers innovative and economical clinical packaging services for investigational medicinal products (IMP). It also supports the packaging of various dosage forms including bottling of solid formulations, and thermo and cold forming blister packaging for oral solids. Sharp also supports the packaging of powder and OSDs in sachets and pouches, oral and transdermal films in strips, and injectables in vials, syringes, and cartridges. Moreover, it is also involved in the packaging of semi-solids such as cream and ointment in tubes. Some of Sharp’s pharmaceutical packaging solutions for solid and liquid drug products are mentioned below: Bottle Packaging for Solids and Semi-solids: Sharp provides pharma packaging contract services for bottle packaging that include component sourcing, carton printing and in-line cartoning or bundling, comprehensive onsite engineering and validation support, serialization and aggregation, and strict quality control for packaged drugs. Sharp also offers high-quality nitrogen flush bottles and bottle packaging for moisture and oxygen-sensitive drugs. Blister Packaging for Oral Solids: Sharp provides various blister packaging solutions including thermoform and cold form blisters, patient packs, hospital unit dose packs, wallet cards, child-resistant lidding, sustainable foil and blister materials, and multiple products per blister. Apart from this, Sharp’s contract blister packaging services also involve multi-color foil printing, in-house tooling design and fabrication, polymer laminates (Aclar, PVC/PVDC, etc.) heat-seal coating resins, and automated visual inspection. Pouches and Sachets for Solids and Transdermal Patches (Primary and Secondary Packaging Services): Sharp has expertise in pouch and sachet packaging filled with solid dose, powder, thin film, and transdermal patch drug products. Sharp’s solid dose packaging solutions offer considerable pouch and sachet packaging backed by quality operations and project management knowledge. Sharp is home to a sizable assemblage of form, fill, and seal technologies. Based on decades of practical expertise, Sharp uses a wide range of innovative film structure materials, such as coated papers, high-barrier foils, and polymer laminates, and offers pharma packaging contract services. It also can support the production of multiple dosage forms for pharmaceutical products. Oral Thin Film and Transdermal Patches: Sharp provides primary and secondary packaging services for oral thin films and transdermal patches. Sharp specializes in die-cutting and pouching sublingual and oral dissolvable films, and transdermal drug delivery systems, and offers specialized pharmaceutical packaging services through quality procedures. It utilizes the most up-to-date solid dose packaging solutions and processes to safely package and safeguard specialty drug products. Sharp’s oral thin film and transdermal patch capabilities include highly accurate dosing by die-cutting laminated products to any size and shape; in-line printing of drug info, bar codes, lot number, expiration date, serialization with optical character verification (OCV); etc. Therefore, Sharp is a pharmaceutical contract packaging organization that offers clinical services, cold chain packaging, clinical packaging and labeling, and commercial packaging. Its pharmaceutical contract packaging service also encompasses primary and secondary clinical and commercial packaging. 

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    04 Mar 2024