Drugmakers are navigating regulatory shifts, trial setbacks and major dealmaking as the FDA advances new models for drug development and political pressure reshapes the approval process.
Here are five recent moves to know:
- The FDA launched a real-time clinical trial pilot with AstraZeneca and Amgen, allowing safety signals and endpoints to be shared with regulators as trials progress — part of a broader push to move away from sequential phase 1, 2 and 3 studies toward continuous trials powered by AI.
- Johnson & Johnson plans to advance its IBD combination therapy JNJ-4804 into phase 3 testing despite missing the primary endpoint in phase 2b trials, focusing on patients who have failed at least two prior treatments after data showed remission rates as high as 49.2% in that subgroup.
- Sanofi asked the FDA to pull its Type 1 diabetes drug teplizumab from, its priority review voucher program after the Center for Drug Evaluation and Research’s acting director, Tracy Beth Høeg, MD, PhD, disagreed with a staff decision to approve the drug, according to a May 6 STAT News report.
- GSK received FDA priority review and breakthrough therapy designation for bepirovirsen, an investigational treatment for chronic hepatitis B, with an October 26 Prescription Drug User Fee Act date assigned following phase 3 trial data showing statistically significant functional cure rates, according to an April 28 news release.
- Bristol Myers Squibb and Hengrui Pharma are partnering on a global collaboration covering 13 early-stage programs in oncology, hematology and immunology, with BMS paying up to $950 million upfront and the deal carrying a potential total value of approximately $15.2 billion, according to a May 13 news release from BMS.
