FDA Advisors Think Novartis’ Serelaxin Could Perform Better On More Difficult Endpoints
Advisory committee rejects heart failure treatment but expects drug may show success if evaluated on harder clinical endpoints.
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Novartis released mixed Phase III data on its heart failure candidate at the American Heart Association Scientific Sessions, showing the drug reduced symptoms of acute heart failure but failed to demonstrate an improvement on a second endpoint, cardiovascular death and hospital stays at 60 days.
PBM reform isn’t expected to ride along with the next government funding packages, which could push any prospect of legislative reform closer to 2025. Meanwhile FTC says it is facing difficulty getting all the information for its investigation.
Pulling the controversial Alzheimer’s drug’s BLA should not exempt Biogen from fulfilling ClinicalTrials.gov reporting requirements for two key studies, even if the research gets terminated, former head of the NIH data repository tells the Pink Sheet.