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 new study findings may pave the way for Bristol Myers Squibb to receive additional approval for Breyanzi in a vulnerable patient population.
The Pennsylvania-based eye disease company had to change its application from an Emergency Use Authorization to a full BLA approval.
The $7 billion transaction by Datavant with Ciox Health will be the nation’s largest “neutral and secure health data ecosystem.”
Not everyone is so confident that Aduhelm will transform the Alzheimer’s drug development landscape.
Despite controversy over the drug’s effectiveness, it appears to have spiked interest in investing in Alzheimer’s drug companies, something that had been on the decline for several years.
United claims Liquidia and a former employee misappropriated its trade secrets such as regulatory submissions and detailed financial forecasts for its inhaled treprostinil.
An ugly symbol of racism appears to have reared its head at a Merck facility in North Carolina. The pharma giant is investigating reports of a noose found hanging at a construction project on the 262-acre facility.
Grail presents its first data from the interventional PATHFINDER trial of Galleri, its multi-cancer early detection blood test. Galleri is now available in the U.S. by prescription.
June is turning out to be a busy month for PDUFA dates for the U.S. Food and Drug Administration. Here’s a look at this week’s dates.
On June 5, the world marks the 40th anniversary of the HIV epidemic. Biopharma researchers continue to develop safe and effective treatments with an eye to a potential cure.