Policy
Robert Kramer, former CEO of Emergent BioSolutions, allegedly earned more than $10.1 million by executing trades with information related to the company’s manufacturing operations that had yet to be made public.
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Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 29, 2020.
DBV Technologies, located just outside Paris, announced it is cutting jobs while it awaits news from the U.S. Food and Drug Administration (FDA) about its application for Viaskin Peanut.
The U.S. Food and Drug Administration issued a Complete Response Letter, a rejection, of Allergan’s Biologics License Application for Abicipar pegol for neovascular age-related macular degeneration.
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.