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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BioSpace sat down with Sven Kili, 2022 ISCT Annual Meeting co-chair, to preview the event, which will focus on 4 key subject areas including launch and commercialization of cell and gene therapies.
David Sabatini has withdrawn his name for consideration for a faculty post at New York University Langone Health.
GPH101 is an investigational next-generation gene-edited autologous hematopoietic stem cell (HSC) therapy.
Gongda Xue has been found guilty in a Philadephia courtroom of stealing trade secrets from GlaxoSmithKline. This comes after his sister, Yu Xue, was also convicted for a similar crime.
Teva announced that it had reached a deal with Lupin over Lupin’s Abbreviated New Drug Application (ANDA) for generic deutetrabenazine - an upcoming competitor to Hungtington’s drug Austedo.
The FDA placed a clinical hold on the program due to a determination that there is insufficient information to support dose escalation with the product.
Arguments regarding the Purdue Pharma opioid settlement continue to be heard in court, Natera battles a class-action lawsuit, Walgreens is involved in a public nuisance suit and more.
Public health officials are seeing a notable rise in cases and expressing concerns over more subvariants of the SARS-CoV-2 virus. For those stories and more, continue reading.
The FDA is quickly catching up after COVID-19 disrupted typical review timelines and planned inspections and Monday morning held bad news for Coherus, Junshi and Axsome.
As May gets off to a slow start for the FDA calendar, a few companies have important target action dates.