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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MediciNova, Inc. announced that the U.S. Food and Drug Administration has completed its review of the protocol and determined that MediciNova may proceed with a Phase 2b/3 clinical trial of MN-166 in amyotrophic lateral sclerosis.
The life science industry is continually making advancements in every area! We want to know what cool science innovations are currently in progress and the professionals behind them.
Novartis will use a priority review voucher to expedite review of the treatment that could hit blockbuster status within two years of launching.
The vast majority of immune cells are found in the gut but historically, the gut has been viewed as a liability to drug development. The question of whether or not greater understanding of harnessing the gut could drive more promising drug development has led to the formation of a new company, Kintai Therapeutics.
Auris Medical Holding Ltd. announced that the Nasdaq Hearings Panel has granted the Company’s request for the continued listing of the Company’s securities on The Nasdaq Capital Market.
TLC announced the successful completion of its End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) on receiving guidance, and discussing the clinical and regulatory pathway for a potential U.S. approval of TLC599, a BioSeizer® liposomal formulation of dexamethasone sodium phosphate for the treatment of knee osteoarthritis.
The FDA’s approval marks the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer.
Developing a Human Factors Validation Plan with Consideration for the Digital Health Marketplace
Polyphor AG announced that the US Food and Drug Administration has designated murepavadin as a Qualified Infectious Disease Product in four additional indications; hospital-acquired bacterial pneumonia, acute bacterial skin and skin structure infection, bloodstream infection and complicated intra-abdominal infection.
Sprout wanted the warning regarding alcohol to be completely removed but the FDA said it must remain, although with a caveat.