Regulation and biotech correspondent.
Theo Adeyemi covers drug regulation and the biotech industry for Clinical Observer. He writes from regulators' notices, company filings and published reporting.
Interim Phase 3 DeLLphi-305 data showed median overall survival of 21.1 months with tarlatamab plus durvalumab versus 12.7 months with durvalumab alone in extensive-stage small cell lung cancer.
The patient in a Phase 1 multiple sclerosis study developed septic pneumonia after receiving an immunosuppressant, the company said.
In phase 3 trials, about one in five adults reached a functional cure after a six-month course, but a boxed warning requires close monitoring.
Final VISIONARY results presented at ASN show a 97.1% lower hazard of kidney function decline or failure versus placebo over two years.
The injectable antisense drug is approved for certain adults without cirrhosis. In two trials, 19% maintained viral control after stopping all hepatitis B treatment.
The deal, announced October 20, places Orchestra’s clinical-trial agents inside OpenAI’s Rosalind unit after a year of large AI health investments and mixed clinical evidence.
A 10-member FDA advisory committee voted 10-0 on safety, 6-4 on effectiveness and 7-2 with one abstention that benefits outweigh risks.
