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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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One month after Vaxart announced the selection of its lead vaccine candidate for COVID-19, the Bay Area-based company said it has been selected to participate in the U.S. government’s Operation Warp Speed program.
Shares of Zogenix were up more than 16% in premarket trading following the regulatory approval of the epilepsy drug Fintepla for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy, in patients ages two and above.
Novartis, Novartis Hellas and Alcon Inc. have agreed to pay a total of more than $346 million to settle bribery charges under the Foreign Corrupt Practices Act (FCPA), which is a U.S. anti-bribery law.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 26, 2020.
Regeneron Pharmaceuticals said it will vigorously defend federal charges that it was involved in a kickback scheme to bolster sales of its blockbuster macular degeneration drug, Eylea.
COVID-19-related testimonies will continue in Congress today, with representatives from the Biotechnology Innovation Organization (BIO) expected to address the current pandemic as well as key priorities that will need to be in place in order to effectively respond to the next global viral threat.
Speaking before Congress on Tuesday, Dr. Anthony Fauci urged people to adopt strategies that involve wearing a mask in public, maintaining social distance and avoiding large gatherings of people.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 24, 2020.
The U.S. Food and Drug Administration greenlit Karyopharm Therapeutics’ Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) under accelerated approval.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 22, 2020.