Policy
The FDA’s drug review process can often be “unpredictable,” and review teams typically “differ greatly” in what they ask of drug sponsors, Sen. Bill Cassidy said.
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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
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.
Republican Senator Rand Paul is under fire from government watchdogs for failing to properly disclose a $15,000 purchase of Gilead Sciences stock made by his wife last year.
Citing a study from Johns Hopkins University, researchers found that immunocompromised people are 485 times more likely to end up in the hospital or die from COVID-19.
Emergent BioSolutions has approval to resume manufacturing vaccines, but its lawsuit issues haven’t gone away as easily.
The FDA indicated the drug couldn’t be approved in its present form and asked for another clinical trial of the drug be run before they reapplied.