Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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The Inflation Reduction Act, which is expected to have wide-ranging implications for the pharmaceutical industry, will still need to go to the House of Representatives.
The FDA has had a busy week, accepting drug applications, approving clinical trials and granting various special designations for Gamida Cell, Cellectis, Scynexis & more.
With more than 6,600 cases of monkeypox in the United States, the Biden administration declared the viral outbreak a public health emergency as cases continue to rise across the nation.
Experts from U.S. health regulatory agencies have announced plans to conduct a clinical trial to assess the safety and efficacy of TPOXX (tecovirimat) as an antiviral for monkeypox.
In its Q2 conference call, Sarepta Therapeutics indicated plans to accelerate its timeline for SRP-9001 a gene therapy for Duchenne muscular dystrophy (DMD).
The debate over drug pricing tends to heat up during election season. With the mid-terms in November, we’re going through the cycle once again, sparked by provisions in the Inflation Reduction Act.
Whistleblowers Erika Cheung and Tyler Shultz discussed their experiences at Theranos during the recent 2022 AACC Annual Scientific Meeting & Clinical Lab Expo.
The FDA has placed a clinical hold on Beam Therapeutics’ leukemia/lymphoma therapy and has lifted the hold on Celyad’s CAR-T candidate for colorectal cancer.
The FDA granted Priority Review for omidubicel with a target action date of January 30, 2023. Omidubicel is a first-in-class, advanced NAM (nicotinamide)-enabled stem cell therapy.
The end of July is busy for the FDA, with Coherus, Sanofi, Acadia, Myovant and Pfizer having PDUFA dates filling the calendar. Here’s a look.