Bio Analysis
Seventeen of them have already been licensed outside their home market, and the companies that will sell most of them in the US and Europe are Merck, Astra...
November 05, 2026 | Analysis
Where things stand. As of 2 November 2026, the National Healthcare Security Administration (NHSA) has not published the 2026 National Reimbursement Drug Li...
November 03, 2026 | Regulatory
Obesity was the most searched therapeutic area of 2026, and for most readers the story still has two names in it. Semaglutide and tirzepatide set the bench...
November 02, 2026 | Analysis
Japan's off-year drug price revision stopped being a question of whether some time ago. When the health and finance ministers closed the FY2026 budget roun...
October 29, 2026 | Analysis
Seventeen times in 2026, the US Food and Drug Administration or the European Commission cleared a biosimilar that was developed or made in Asia-Pacific. Ni...
October 28, 2026 | Analysis
Every January, regulatory affairs teams across Asia-Pacific rebuild the same spreadsheet. Which markets will designate this asset as an orphan? Which will ...
October 27, 2026 | Analysis
Ask a regulatory affairs lead in Tokyo, Seoul or Singapore what the rules are for using a machine learning model in a drug submission, and the honest answe...
October 22, 2026 | Analysis
Every October, the same headline writes itself. India leads the count of US FDA warning letters to Asian drug plants, China follows, and the rest of the re...
October 21, 2026 | Analysis
If you are building a 2027 trial budget this month, you are probably working from a spreadsheet with one row per country and a column headed "start-up". Mo...
October 19, 2026 | News
AT A GLANCE 12 generic makers with a public launch in India, selling 20 brands between them Rs 1,290 lowest stated monthly price, for vials...
October 09, 2026 | Analysis
Method in brief What counts. A CAR-T cell therapy approved on one of seven national registers: China's NMPA, Japan's PMDA and MHLW, Korea's MFDS, ...
October 08, 2026 | Analysis
Universities and public research institutes across the region are advancing research in cancer treatment, cell therapy, biologics and other emerging fields...
October 07, 2026 | Opinion | By Hajjerah TMK Hassan, Director, Discovery and Channels - ASEAN |Cytiva
Every Hong Kong biotech applicant has to tell investors what it will do with the money it raises. On the evidence of the twelve 18A application proofs that...
October 07, 2026 | Analysis
Approvals get counted, deals get ranked, listings get priced. The other half of the year, the programmes that stopped, the applications that came back, the...
October 02, 2026 | Analysis
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