Policy
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
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
A team of more than 60 scientists and bioethicists have signed a letter urging Pfizer to wait until late November before the company seeks FDA authorization of its COVID-19 vaccine candidate in an effort to ensure rigorous safety standards have been met.
On Face the Nation, Gottlieb said hospitalization rates in the United States for COVID-19 had been in a state of decline, but those numbers are now rising, which goes hand in hand with an increase in infection rates.
Pennsylvania-based Inovio said the regulatory agency has additional questions about the Phase II/III trial regarding the vaccine candidate itself, known as INO-4800, as well as the company’s Cellectra 2000 delivery device.
During his 2016 campaign, President Trump railed against high pharmaceutical prices, making promises to stand up for Americans who were being “slaughtered” on drug pricing. Now, the FDA has issued a final regulation intended to fulfill Trump’s promises.
New York’s governor hinted he would delay distribution of a quickly approved vaccine until its safety and efficacy could be vetted by a panel of state scientists and researchers.
The late-stage study is part of an agreement struck between the company and the U.K. government last month that includes providing 60 million doses of the vaccine, should it be approved.
The company allegedly used a foundation as a conduit to pay the copays of Medicare patients who were taking Letairis, Gilead’s pulmonary arterial hypertension drug.
The U.S. Food and Drug Administration (FDA) is wrapping up the month of September with a few PDUFA dates. Here’s a look.
The move was announced due to the advisor’s role in overseeing a clinical study for Moderna’s mRNA vaccine candidate.
Under that designation, Mereo may qualify for a voucher that can be used for a priority review of a subsequent marketing application for a different product than Setrusumab.