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.
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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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While the FDA is trumpeting this new initiative as “sweeping reforms” to the way drug companies can advertise, experts say the regulator is going after a problem that doesn’t exist.
The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.
Like the first batch of appointees to the CDC’s vaccine advisory committee, several of the new panelists have documented histories of vaccine and COVID-19 skepticism.
Some observers see risks to becoming over-reliant on local facilities, noting the potential need for trade partners if domestic production is disrupted.
President Donald Trump is considering tariff exemptions for certain “non-patented” pharmaceuticals, though the White House has yet to release specific guidelines.
A draft executive order obtained by The New York Times purports to clamp down on the pharmaceutical industry’s ability to buy new molecules from biotechs based in China, along with a number of other proposed reforms.
New draft guidelines suggest the FDA is open to exercising regulatory flexibility for non-opioid drugs being developed for chronic pain.
Former CDC director Susan Monarez and former chief medical officer Debra Houry will appear in front of the Senate HELP Committee on Sept. 17.
In a livestreamed meeting Tuesday afternoon, Health Secretary Robert F. Kennedy Jr. drew a dark portrait of the state of America’s health while addressing the MAHA Commission’s most recent report, which includes plans to research potential links between vaccines and rising rates of chronic disease.
Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.