Less than two months after receiving priority review status for an NDA, Johnson & Johnson won U.S. FDA approval of Inlexzo, its intravesical gemcitabine-releasing system previously known as TAR-200, to treat adults with Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. Read More
PMV Pharmaceuticals Inc.’s rezatapopt yielded impressive overall response data in ovarian cancer, prompting the firm to aim for a potential accelerated approval filing in early 2027. The news caused the firm’s stock (NASDAQ:PMV) to jump in premarket trading, but shares ended the day at $1.27, down 20%, as investors signaled they are clearly holding out for further data confirming broader market potential for the p53-targeting small molecule. Read More
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. Read More
“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.” Read More
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. Read More
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. Read More
New hires and promotions in the biopharma industry, including: Bicycle, Harvard, Johnson, Lobe, Metaphore, Numab, Pheon, Scenic, Tubulis, Vicero. Read More
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. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Ipsen, Iregene, Medison, NS, Saol, Teva. Read More
