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 Sept. 30 deadline for Congress to reauthorize the FDA’s prescription drug user fee is looming, while advocates and detractors are debating the merits of the funding source.
Two days after unveiling an executive order to boost U.S. biomanufacturing, the White House unveiled plans that include $2 billion to support the initiative.
Novartis confirmed it is the subject of an investigation by the Swiss Competition Commission over possible unlawful patent use.
Biden issued an executive order to keep U.S.-based innovation ahead of advances made by counterparts in China biotechnology and biomanufacturing Monday.
A Manhattan court dismissed a whistleblower lawsuit against Novartis, which had alleged the company paid doctors to promote its multiple sclerosis drug Gilenya.
Pres. Joe Biden vowed to bolster the U.S. biotechnology sector after signing an executive order to improve the fight against cancer.
President Joe Biden tapped Ginkgo Bioworks veteran Renee Wegrzyn to helm the recently-established Advanced Research Projects Agency for Health (ARPA-H).
The FDA is heading into fall with a few Prescription Drug User Fee Act (PDUFA) dates. Here’s a look at this week’s upcoming action.
Although it was a short week due to the Labor Day holiday, the FDA maintained a steady pace of business.
A new report has shed light on some pharmaceutical companies’ attempts to circumvent federal anti-kickback statutes by profiting from large donations to patient assistance organizations.