Global Scans · Pharmaceuticals · Weekly Summary

• [New] If the reduced requirement for CES data can increase the number of available FDA-approved biosimilars, providers and patients will have more choices and the prices for both reference and biosimilar biological products may decrease. / USA Mintz
• [New] The Trump Administration has just announced price agreements with pharmaceutical companies Novo Nordisk and Eli Lilly that will make some GLP-1s more affordable for Americans, including people enrolled in Medicare. EatingWell
• [New] If oral GLP-1 tablets are approved by the US Food and Drug Administration, the lowest dose will cost $149. CNN
• [New] The Food and Drug Administration plans to discard warning labels for hormone therapies for menopausal women, undoing decades-old language cautioning that treatments may increase the risk of cancer or heart disease. Healthcare Dive
• [New] AMR is now a significant global health threat as drug-resistant microbes know no borders and can spread rapidly, exacerbated by factors like poverty, inequality, and natural or human-induced crises. Times Kuwait
• [New] Projects growing pressure from patent expirations, biosimilar competition, and regulatory changes will reduce Amgen's revenues and margins over time. Simply Wall St
• FDA's reviewers will likely continue to expect CES when evaluating 351 (k) BLAs, and biosimilar sponsors should be prepared to establish the scientific value of CAA on a product-by-product basis. JD Supra
• Manufacturing advantages in the form of cost-effective labour, abundant raw materials, and improved infrastructure will fortify Asia Pacific as the global epicenter for aquaculture feed and pharmaceutical innovation and production for the next several years. Persistence Market Research
• Biogen plans to introduce the new drug delivery system for SPINRAZA in early 2028, contingent upon the successful completion of clinical trials and regulatory approval. Biogen Inc.
• Drug manufacturers will remove certain black box warnings on certain hormone replacement therapy treatments prescribed to address menopause symptoms. National Law Review
• The US Food and Drug Administration will remove certain black box warnings from certain hormone replacement therapy treatments. National Law Review
• An antimalarial drug developed by Novartis could become the first novel treatment for the parasitic infection in more than two decades, following study results that showed it helped cure most people treated with it in a Phase 3 trial. BioPharma Dive
• In many circumstances analytical data will be more sensitive than CES in detecting differences between a proposed biosimilar and its reference product. Arnold & Porter
• Barring any delays, France is on track to begin a complete medical cannabis program in 2026, a significant shift for a country with historically strict drug laws. Better Tomorrow Consulting
• Uniquely, France will treat medical cannabis strictly like a pharmaceutical product: only licensed pharmacy operators can supply it, and smokable flower will be limited to sealed vape cartridges. Better Tomorrow Consulting
• Without additional reforms - such as addressing rebate structures, patent thickets, prescriber incentives, biosimilar education gaps, and pharmacy benefit manager transparency - the US may not realize the full potential of biosimilar competition. Center for Biosimilars
• By 2035, quantum AI is predicted to significantly transform healthcare (drug discovery and molecular simulation), finance (portfolio optimization and fraud detection), mobility (traffic flow and energy management), chemicals (material discovery), and supply chains (global routing optimization). TECH TICH | Technology Blogs, News & Product Reviews
• We have shown that for people who regain weight or do not have an optimal weight loss effect from bariatric surgery, adding in a weight loss drug will help them to lose weight, often at a lower dose than is needed in people who have not had surgery. New Atlas
• Biosimilar use has already generated more than $56 billion in savings and that the new regulatory framework could unlock $181 billion in additional savings over the next 5 years. AJMC
• 2025's PharmSci 360 will shine a spotlight on artificial intelligence integration and emerging technologies, including gene therapy and spatial transcriptomics, across bio / pharmaceutical research and manufacturing. BioPharm International
• Several pharmaceutical and biotech firms have disclosed potential exposure in SEC filings, suggesting that BIOSECURE-related risk is now material to investors. Mondaq
• Between now and the beginning of 2031, there's about $200bn worth of revenue that is going to be impacted by either a generic or a biosimilar. Chemistry World
• Positive trial results for Duchenne muscular dystrophy patients were reported last year, and an approval decision from the US Food and Drug Administration is expected in late 2025. Chemistry World

Last updated: 25 November 2025