Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Ipsen, Iregene, Medison, NS, Saol, Teva.
Biopharma happenings, including deals and partnerships, and other news in brief: Circle, Eli Lilly, Ethris, Evonik, Idorsia, Insitro, Lundbeck, Nkgen, Nkmax, Novo Nordisk, Regeneron, Rion, Sandoz, Tolerance, Zipcode.
The U.S. FDA issued new guidance for the development of non-opioid analgesics for chronic pain indications, with specific details on trial design, patient populations and meaningful outcomes, including reducing the nation’s reliance on opioids.
The Hong Kong biotech sector saw record growth this year, expanding 13%, fueled largely by investment in innovation ranging from CRISPR gene editing tools, cell therapies and artificial intelligence in drug discovery, speakers at the BIO Hong Kong conference said Sept. 10.
“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”
It took a memo from the president for the U.S. FDA to begin reining in direct-to-consumer prescription drug advertising with its feel-good messaging and hurried recitation of a few serious adverse events.
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