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DATA COMPILATION #PharmaFlow

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US drug shortages hit record high in Q1 2024, impacts cancer, ADHD drugs; Lilly, Novo ramp up production
Drug shortages are threatening healthcare systems the world over. Be it the US, Canada, Europe or Africa, drug scarcities are straining healthcare systems and costing lives.In the US, the first quarter (Q1) of 2024 saw a staggering 323 drug shortages, the highest number recorded since the American Society of Health-System Pharmacists (ASHP) began tracking such data in 2001. However, Q2 2024 saw active drug shortages reduce to 300 drugs.While the shortages span a wide range of medications, five categories have been severely impacted in the US — central nervous system drugs, antimicrobials, hormone agents, injectable fluids and electrolytes, and chemotherapy drugs. Other critical medications in short supply include drugs to treat attention deficit hyperactivity disorder (ADHD).View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available)Chemo scarcities spark concerns; vaccine shortage hampers mpox response in AfricaIn the US, shortage of at least 21 chemotherapy drugs has impacted cancer treatments. A survey undertaken by the National Comprehensive Cancer Network found 89 percent of participating centers reporting shortages of at least one critical systemic anticancer therapy. These included drugs like vinblastine, etoposide and topotecan. Since early 2023, supply issues have led to what’s now known as the “carboplatin shortage”, a key platinum-based chemo drug that is impacting cancer treatment. Carboplatin is crucial for treating various cancers, including ovarian, lung, and breast cancer.The good news is that there has been a reduction in shortages of platinum-based chemo drugs such as carboplatin and cisplatin. In fact, the FDA website now mentions the shortage of cisplatin as resolved. However, the shortage of carboplatin persists.Meanwhile, Africa is facing an acute shortage of diagnostic kits, treatments and vaccines to fight the outbreak of monkeypox (mpox). The Africa Centers for Disease Control and Prevention estimates it would need 10 million vaccines to stop the outbreak. Bavarian Nordic’s Jynneos is currently the only widely approved mpox vaccine, and countries like the US, Spain, France and Germany have pledged doses of Jynneos to help Africa fight the outbreak.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) Drug shortages impacts ADHD patients in US; Canada implements tiered systemThe US Food and Drug Administration (FDA) first reported a shortage of Adderall, a common ADHD treatment, in October 2022. Since then, the shortage has spread to other crucial medications like Ritalin, Vyvanse, and Focalin. This is a significant issue for the roughly 10 million adults and six million children in the US who rely on such drugs to manage their ADHD symptoms.An already concerning shortage of ADHD medications in the US has the potential to worsen due to some recent events. The Centers for Disease Control and Prevention (CDC) issued a health advisory in June, warning that the arrest of two telehealth executives from Done Global, a digital health company, could exacerbate the ADHD medication shortage. Done Global was accused of illegally distributing Adderall online. The arrests could disrupt care not only for Done Global patients but also for those who use other telehealth services.Meanwhile, Canada has implemented a tiered system for addressing drug shortages, with tier 3 shortages being those with the greatest potential impact on the country’s drug supply and healthcare system. Currently, there are 20 drugs listed under tier 3.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) GLP-1 drug shortages create US$ 1 bn shadow industry; Lilly, Novo expand capacitiesThe shortage of glucagon-like peptide-1 (GLP-1) receptor agonists, such as Ozempic, Saxenda, Trulicity, Victoza, Mounjaro, and Zepbound, has been grabbing headlines. These drugs are used in the treatment of diabetes and in weight management.The shortage of these drugs has led to a surge in demand for compounded versions of these medications, creating both opportunities and significant risks. While the FDA’s Food, Drug, and Cosmetic Act allows it to turn a blind eye to pharmacists producing and selling non-approved compounded versions under certain circumstances, this practice has led to a billion-dollar shadow industry of compounded GLP-1 drugs.Eli Lilly has discovered compounded drugs advertised as tirzepatide (Mounjaro and Zepbound) with significant safety, sterility, and efficacy issues. In response to the safety risks, Lilly has taken legal action against several wellness centers, medical spas, and other sellers in the US.To address the supply issues, Lilly has announced its largest manufacturing investment yet, investing an additional US$ 5.3 billion at its Indiana site. Similarly, Novo Nordisk’s parent company is acquiring Catalent for US$ 16.5 billion to increase Wegovy production. Novo is also investing US$ 4.1 billion to develop a new manufacturing facility in Clayton, North Carolina (US).The FDA website continues to list Novo and Lilly’s GLP-1 drugs as “Currently in Shortage”, even though the drugmakers say otherwise. The EMA website says the shortage of Novo’s Wegovy has been resolved but Lilly’s Trulicity and Novo’s Saxenda continue to be in shortage.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) FDA works closely with cancer drugmakers; France introduces roadmap to address drug shortagesApart from pharma companies, health authorities and governments are also taking steps to reduce drug shortages. FDA is working closely with five cancer drug manufacturers to increase production capacities. It has also facilitated the re-entry of a previously discontinued cisplatin product into the market.On the legislative front, the US Senate Finance Committee has proposed a draft of a policy that would incentivize generic drug manufacturers to prioritize production of essential medications. These incentives include minimum three-year contracts with stable pricing, contingency contracts with alternate manufacturers, transparency in quality control issues, and modifications to the Medicaid Drug Rebate Program. France, like most European nations, is also facing shortages of medicines like insulin and anti-cancer drugs. But most problematic are its shortages of antibiotics, paracetamol and corticoids. The French government has introduced a new three-year "roadmap" (from 2024 to 2027) to address these shortages. A significant step in this direction is the planned opening of the first European paracetamol factory in Toulouse in 2025, which will help reduce Europe’s dependence on China, India, and the US for this widely used medication.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) Our viewThe global drug shortages underscore the fragility of pharmaceutical supply chains and the urgent need for reform. Longstanding drug shortages, particularly those affecting cancer treatments, antibiotics, and essential medications often stem from the low profitability of generic drugs.While investments in manufacturing capacity and regulatory measures are steps in the right direction, a more comprehensive, concerted global approach is needed to resolve the deep-seated systemic issues in the pharmaceutical industry.  

Impressions: 5362

https://www.pharmacompass.com/radio-compass-blog/us-drug-shortages-hit-record-high-in-q1-2024-impacts-cancer-adhd-drugs-lilly-novo-ramp-up-production

#PharmaFlow by PHARMACOMPASS
29 Aug 2024

STOCK RECAP #PipelineProspector

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Pipeline Prospector November 2025: Kimberly-Clark to buy Kenvue for US$ 48.7 bn; FDA approves Novartis’ gene therapy
November saw several big ticket acquisitions across the consumer health and biopharma space, including the US$ 48.7 billion acquisition of Johnson & Johnson’s consumer health unit Kenvue by Kimberly-Clark and Pfizer’s up to US$ 10 billion acquisition of obesity-focused biotech Metsera. Additionally, the trend of companies announcing capacity expansions continued unabated.The month saw several key drug approvals by the US Food and Drug Administration (FDA), including Kura Oncology-Kyowa Kirin’s Komzifti (ziftomenib) for treating adults with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation.The indices rose substantially during the month. The Nasdaq Biotechnology Index (NBI) rose 8.85 percent, from 5,344.91 at the end of October to 5,818.03 by November-end. The SPDR S&P Biotech ETF (XBI) gained 10.97 percent from 110.98 to 123.16. The S&P Biotechnology Select Industry Index (SPSIBI) also advanced 9.08 percent — from 8,789.93 to 9,588.09. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel)Pfizer clinches up to US$ 10 bn deal for Metsera; Merck to buy Cidara for US$ 9.2 bnPfizer inked an agreement worth up to US$ 10 billion to acquire obesity-focused biotech Metsera. The deal ended a competitive bidding process between Pfizer and Novo Nordisk. Pfizer had filed lawsuits, alleging that Metsera breached an earlier merger agreement. Metsera accepted Pfizer’s revised offer after raising concerns about potential antitrust risks associated with Novo’s competing bid. In early November, Kimberly-Clark announced the acquisition of Johnson & Johnson’s consumer health unit — Kenvue — in a cash-and-stock deal valued at US$ 48.7 billion. The merger will create a consumer health company with expected annual revenue of about US$ 32 billion and a portfolio of highly-valued brands, including Tylenol (paracetamol), Neutrogena, Aveeno, and Listerine.Merck announced the acquisition of Cidara Therapeutics in a deal valued at US$ 9.2 billion. The acquisition gives Merck access to an experimental influenza antiviral designed to provide season-long protection with a single dose. Its stock rose 22 percent in November.Johnson & Johnson is buying Halda Therapeutics for US$ 3.05 billion in cash. Halda, a Connecticut-based biotech, adds early-stage cancer programs to J&J’s pipeline, including a lead candidate in prostate cancer.Like Pfizer and Novo Nordisk, Lundbeck and Alkermes were also embroiled in a bidding war for Avadel Pharmaceuticals. Lundbeck later withdrew from the race, clearing the way for Alkermes, which eventually agreed to acquire Avadel for US$ 2.37 billion.Drugmakers continued to announce plans to expand capacities. Eli Lilly (whose stock rose 22 percent in November) announced plans to invest US$ 3 billion to build an oral medicines manufacturing site in the Netherlands to support its experimental GLP-1 pill, orforglipron. It will also invest more than US$ 1.2 billion to expand its facility in Puerto Rico.AstraZeneca said it will invest US$ 2 billion to expand its manufacturing capacity in Maryland (US). And Novartis said it will set up a flagship manufacturing hub in North Carolina, post a trade agreement that lowers US tariff rates on Swiss imports. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel) FDA approves Komzifti for leukemia; Bayer’s Hyrnuo wins accelerated approval for lung cancerFDA approved Komzifti (ziftomenib), a once-daily pill from Kura Oncology and Japan’s Kyowa Kirin, for adults with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation.The agency also expanded the approval of Epkinly (epcoritamab), developed by AbbVie and Genmab, for use as a second-line treatment of relapsed or refractory follicular lymphoma.The agency also granted accelerated approval to Bayer’s Hyrnuo (sevabertinib) for people with non-squamous non-small cell lung cancer (NSCLC) that has recurred or spread and carries a specific HER2 mutation.Moreover, FDA approved UCB’s Kygevvi (doxecitine and doxribtimine), the first treatment for thymidine kinase 2 deficiency (TK2d), a rare inherited mitochondrial disorder that leads to progressive muscle weakness and respiratory complications.Further, FDA approved Redemplo (plozasiran sodium), Arrowhead Pharmaceuticals’ first marketed drug for adults with familial chylomicronemia syndrome (FCS), a rare genetic disorder that causes extremely high levels of triglycerides in the blood that can cause acute pancreatitis. During the month, Arrowhead’s stock price went up by 31 percent.FDA also granted accelerated approval to Otsuka’s Voyxact (sibeprenlimab-szsi) to help reduce excess urinary protein in adults with IgA nephropathy, a chronic kidney disease.Separately, FDA approved Novartis’ gene-replacement therapy Itvisma (onasemnogene abeparvovec-brve) for patients aged two years and older with spinal muscular atrophy (SMA) caused by an SMN1 mutation. Itvisma uses the same active ingredient as Zolgensma and is the first approved gene therapy for a broader SMA population.Other than these, the regulator approved the Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) regimen for people with muscle-invasive bladder cancer who cannot receive cisplatin-based chemotherapy. The combination is the first and only approved regimen that can be used before and after surgery. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel) Bayer’s asundexian shows benefit in strokes; Novo’s Rybelsus fails Alzheimer’s trialsThe month saw several trial wins. For instance, Bayer reported positive phase 3 results for asundexian, an experimental blood thinner that lowered the risk of repeated strokes without increasing major bleeding. In another phase 3 trial, Amgen’s Repatha (evolocumab) reduced major cardiovascular events in adults without prior heart attack or stroke when added to statins or other therapies.Cogent Biosciences (stock up 146 percent in November) reported strong phase 3 results for bezuclastinib in combination with sunitinib in patients with gastrointestinal stromal tumor (GIST) whose disease had progressed after earlier treatment.In trial failures, Novo Nordisk’s oral semaglutide pill, Rybelsus, failed to slow Alzheimer’s disease progression in two large phase 3 trials. The studies showed no benefit over placebo in more than 3,800 people with early-stage disease.The agency also paused two phase 3 studies of Intellia’s gene-editing therapy nexiguran ziclumeran after a patient developed severe liver problems. The share price of the company fell by 33 percent over the month.November wasn’t a good month for Sarepta (its stock was down 13 percent). The company said its late-stage trial of casimersen and golodirsen for Duchenne muscular dystrophy did not meet its main goal. Moreover, FDA added a boxed warning to Sarepta’s gene therapy Elevidys (delandistrogene moxeparvovec-rokl) following the deaths of two non-ambulatory children from acute liver failure. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel) Our viewAfter a few difficult years marked by stock-market volatility and disruptions in global supply chains, the pharmaceutical sector is finally showing signs of sustained growth and stability. The uptick in big-ticket M&A activity is a clear indicator of the industry’s confidence. These are all huge positives as we move closer to 2026. Access the Pipeline Prospector Dashboard for November 2025 Newsmakers (Free Excel) 

Impressions: 293

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-november-2025-kimberly-clark-to-buy-kenvue-for-us-48-7-bn-fda-approves-novartis-gene-therapy

#PharmaFlow by PHARMACOMPASS
04 Dec 2025

NEWS #PharmaBuzz

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https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-12-2025-41744.pdf

FDA
12 Nov 2025

https://www.expresspharma.in/farmson-unveils-rs-300-crore-acetic-anhydride-unit-in-vadodara/

EXPRESSPHARMA
07 Nov 2025

https://www.fiercepharma.com/pharma/kenvue-readies-defenses-texas-ag-paxton-sues-over-alleged-tylenol-autism-link

FIERCE PHARMA
28 Oct 2025

https://www.reuters.com/sustainability/boards-policy-regulation/trumps-tylenol-claims-limit-ma-options-parent-company-kenvue-2025-10-14/

REUTERS
14 Oct 2025

https://www.reuters.com/business/healthcare-pharmaceuticals/us-republicans-democrats-split-party-lines-trumps-tylenol-autism-claim-kff-poll-2025-10-09/

REUTERS
09 Oct 2025

https://www.reuters.com/business/healthcare-pharmaceuticals/eu-medicines-regulator-paracetamol-safe-be-used-during-pregnancy-2025-09-23/

REUTERS
23 Sep 2025