Pharminent

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.

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.

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.

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.

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.

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.

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.

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.

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.

CSL names Deborah Waterhouse chief executive and managing director

CSL appointed Deborah Waterhouse as chief executive officer and managing director.