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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.
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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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A disappointed Merck said it was reviewing its options for a possible appeal, while a pleased Gilead said if an appeal came, it was confident a higher court would come to the same verdict as the federal appeals court.
As Nancy Pelosi’s drug pricing reform bill winds its way through the House toward an expected full vote in coming days, life sciences organizations are marshalling their forces in opposition to what they see as innovation-killing legislation.
The approval was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway.
Novartis said it will work diligently with the FDA to resolve the partial clinical hold and resume the study.
Makena has been approved to decrease preterm birth in pregnant women with a previous spontaneous preterm birth.
Reynolds claimed that his company’s product, called NeuroRelease, could essentially end paralysis.
STA Pharmaceutical Co., Ltd., – a subsidiary of WuXi AppTec – announced today that its Jinshan manufacturing facility in Shanghai, China has successfully passed an inspection by the European Medicines Agency with no critical and no major findings.
The plaintiffs in the case alleged that Forest intentionally attempted to delay and impair generic competition of its immediate-release formulation of Namenda.
The U.S. Department of Justice said the two charitable organizations, Good Days and Patient Access Network Foundation, allowed seven pharmaceutical companies to funnel money through their organization to provide Medicare patients with assistance in paying for medications developed by those companies.
Arcutis Also Announces Enrollment of Last Patient in 52-Week Long-term Safety Study of ARQ-151 Cream as a Potential Topical Treatment for Plaque Psoriasis