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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As COVID-19 surges to earlier pandemic levels in the U.S., federal health officials are expected to authorize a third booster shot eight months after receiving the second of the Moderna and Pfizer-BioNTech vaccines, and probably the Johnson & Johnson vaccine as well.
In the past few weeks, China reminded the world that it is, first and foremost, a Communist nation. The recent crackdowns on the high-tech and education industries make some wonder what other changes will be next.
In a patent infringement lawsuit filed against Eli Lilly, Teva Pharmaceuticals won three and lost six patents. The patent lawsuit was over Teva’s Ajovy (fremanezumab-vfrm) to prevent migraines.
As the COVID-19 pandemic continues with surges in the U.S. in unvaccinated people, biopharma companies are still working on new vaccines and therapies against the disease.
Patient enrollment in the Phase I study will resume, the company announced this morning.
Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. FDA, which will speed up the regulatory process for these medications.
The U.S. FDA had a very packed calendar for this week, but almost everything on it was under a Priority Review pathway.
The amended EUA is aimed at patients who have undergone solid organ transplants or those diagnosed with conditions that have an “equivalent level of immunocompromised.”
This morning, the White House released its initiative to lower healthcare costs that includes the ability for Medicare to negotiate prices for prescription drugs.
Aubrey de Grey has been accused by two women of predatory behavior, an allegation de Grey denies. SENS has placed him on administrative leave pending further investigation.