Stick To Basics: Attempt To Improve Heart Failure Symptomatic Endpoint Trips Up Novartis’ Serelaxin
While on paper a surrogate endpoint was OK with the agency, company’s attempt to advance endpoint by incorporating clinical outcomes gets pushback from FDA and its advisors.
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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.