Pharminent · Daily Brief
October 22, 2026
Regulatory & Approvals
FDA approves GSK’s hepatitis B drug Hibsago licensed from Ionis
The FDA approved GSK’s Hibsago (bepirovirsen), an antisense oligonucleotide licensed from Ionis Pharmaceuticals, for chronic hepatitis B. GSK describes the drug as a potential “functional cure” for chronic infections and part of its goal of reaching £40 billion in annual revenue by 2031.
BioPharma Dive →$IONS$GSK
EC approves Keytruda plus Padcev for muscle-invasive bladder cancer
The European Commission approved MSD’s Keytruda in combination with Padcev as a perioperative treatment for adults with resectable muscle-invasive bladder cancer.
Pharmaceutical Technology →
FDA accepts Formycon and Zydus’ proposed Keytruda biosimilar for review
Formycon and Zydus announced on October 13, 2026 that the FDA accepted for review the Biologics License Application for FYB206, a proposed biosimilar to Merck’s KEYTRUDA (pembrolizumab); it is the first publicly announced FDA acceptance of an application for a proposed KEYTRUDA biosimilar. Formycon also submitted the regulatory dossier in Europe.
Big Molecule Watch →$MRK
Alvotech and Advanz file European application for Eylea 8 mg biosimilar
Alvotech and Advanz Pharma announced on October 14, 2026 the submission of a European regulatory application for AVT29, a proposed biosimilar to Eylea 8 mg (aflibercept 114.3 mg/mL), marketed as Eylea HD in the United States. It is the first publicly announced regulatory submission worldwide for a proposed biosimilar to the product.
Big Molecule Watch →
Bipartisan US bill targets faster rare disease clinical trials
A new bipartisan bill aims to speed rare disease drug development by making clinical trials faster, cheaper and more accessible to patients.
CNBC →
UK clinical trial setup times down 35%, data show
New data show delivery times for clinical research in the UK have fallen 35% following reforms to the country’s clinical research regulatory framework.
Pharmaphorum →
Clinical Data
Arcus reports casdatifan follow-up data in kidney cancer
Arcus Biosciences reported new follow-up results for casdatifan in kidney cancer that analysts said were impressive, while TriGemX announced a SPAC deal and Eli Lilly and AstraZeneca formed new partnerships.
BioPharma Dive →$AZN$LLY
UK AD-SMART study to test multiple Alzheimer’s drugs in parallel
The UK study AD-SMART will test multiple repurposed and new drugs in parallel in an effort to cut the time needed to gauge their efficacy in Alzheimer’s disease.
Pharmaphorum →
Deals & Partnerships
Astellas and AI Proteins sign miniprotein therapeutics research deal
AI Proteins and Astellas Innovation Management signed a research collaboration and license agreement to discover and develop miniprotein therapeutics.
Pharmaceutical Technology →
Business & Finance
CSL names Deborah Waterhouse chief executive and managing director
CSL appointed Deborah Waterhouse as chief executive officer and managing director.
PharmExec →
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