InScienceWeTrust BioAdvisory reposted this
https://conta.cc/4dUE8zs The FDA is considering limiting approvals for PD-1 inhibitors in advanced gastric and gastroesophageal junction adenocarcinoma, and esophageal squamous cell carcinoma. They are holding an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss data supporting the restriction based on PD-L1 expression. This meeting would impact the existing or ongoing regulatory decisions on PD-1 blockers from BeiGene, Merck, and Bristol Myers Squibb. Pfizer improved its clinical trial success rates from 2% in 2010 to 21% in 2020 by implementing the "Three Pillars of Survival" strategy. This approach focused on testing the mode of action, selecting the right indication, and objective decision-making. The success rates in mid- and late-stage trials significantly increased. Novartis and Versant Ventures launched Borealis, a new kidney biotech, with $150M. Borealis includes core members of Chinook Therapeutics, a Novartis Company, acquired by Novartis in 2023 for $3.2Bn. The new company will focus on developing RNA therapies for kidney diseases. Partnerships between biopharma and VC funds are increasing, and more VC money would likely flow into VC/biopharma collaborations.