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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On Monday, the companies announced their checkpoint inhibitor Libtayo (cemiplimab-rwlc) won Food and Drug Administration approval for lung cancer.
The U.S. FDA issued new guidance for vaccine makers as it is preparing for the possibility of needing to approve COVID-19 booster shots against variants of the SARS-CoV-2 virus.
Otezla, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) directed for cyclic adenosine monophosphate (cAMP), may indirectly modulate inflammatory mediators in certain conditions, but the specific underlying mechanisms are not clearly understood.
The U.S. Food and Drug Administration said that data from BrainStorm Cell Therapeutics’ ALS Phase III trial does not meet the threshold of substantial evidence needed to support a BLA for the company’s ALS NurOwn therapy.
The funding, provided by the Biomedical Advanced Research and Development Authority at the Department of Health and Human Services, is enough to advance the test to commercialization.
AstraZeneca will voluntarily withdraw the use of its checkpoint inhibitor Imfinzi (durvalumab) as a treatment for bladder cancer in the United States following a failure to meet endpoints in a post-approval clinical study.
The tebentafusp has earned a breakthrough designation for ocular cancer. The company is planning regulatory filings in the U.S. later this year and in Europe thereafter.
AbbVie and its partner company, Medytox of South Korea, have settled a years-long intellectual property legal dispute with California’s Evolus over Jeuveau, a potential rival to AbbVie’s blockbuster Botox, which it gained through the acquisition of Allergan.
An open letter from a group of academics is urging the Biden administration to implement updates to guidance and standards that will better protect high-risk workers from the novel coronavirus that causes coronavirus disease 2019 (COVID-19).
BeiGene’s Bruton’s kinase inhibitor Brukinsa (zanabrutinib) could be on its way for regulatory approval as a potential treatment for Waldenström’s macroglobulinemia (WM), a type of non-Hodgkin lymphoma.