Global Scans · Pharmaceuticals · Weekly Summary

• [New] 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
• [New] 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
• [New] 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.
• [New] Drug manufacturers will remove certain black box warnings on certain hormone replacement therapy treatments prescribed to address menopause symptoms. National Law Review
• [New] The US Food and Drug Administration will remove certain black box warnings from certain hormone replacement therapy treatments. National Law Review
• [New] 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
• [New] In many circumstances analytical data will be more sensitive than CES in detecting differences between a proposed biosimilar and its reference product. Arnold & Porter
• [New] 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
• [New] 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
• [New] 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
• [New] 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
• [New] 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
• Patent expirations of major biologics will create $200 billion in biosimilar opportunities by 2030. PharmiWeb.com
• Within 15 years, more than a third of new FDA drug approvals will trace their lineage to China - up from 5% today. MIT Initiative for New Manufacturing Substack
• A new World Health Organization study finds 1 in 6 infections worldwide are resistant to some antibiotics, highlighting a growing threat from drug-resistant bacteria. NPR
• The cancer immunotherapy sector reached $137.70 billion in 2024 and is projected to hit $261.74 billion by 2033 as major pharmaceutical companies unveiled breakthrough data at the European Society for Medical Oncology Congress in Berlin. Yahoo Finance Canada
• The age of the GLP-1 drug has reached yet another milestone, with the US Food and Drug Administration green-lighting Novo Nordisk's once-daily oral semaglutide pill to treat people at high risk of cardiovascular events like heart attack and stroke. New Atlas

Last updated: 18 November 2025