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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Bristol Myers Squibb and bluebird bio are eying a potential quick approval for a CAR-T treatment for multiple myeloma after the U.S. Food and Drug Administration accepted the Biologics License Application under priority review.
The U.S. National Institutes of Health (NIH) awarded seven companies and academic institutions grants to develop digital health technology to help with the COVID-19 pandemic.
Legend’s CEO and Board Chairman, Fangliang “Frank” Zhange, was placed on “residential surveillance” by PRC law enforcement.
Last week, HHS Secretary Alex Azar assumed all final authority in deciding new rules regarding food, medical devices and new medications.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 21, 2020.
Johnson & Johnson has become the next big pharma player to be accused in New York State’s Department of Financial Services opioid industry probe.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 18, 2020.
Robert Redfield, director of the U.S. Centers for Disease Control and Prevention, testified yesterday before the U.S. Senate Appropriations subcommittee on labor, health and human services, education and related agencies.
With both autumn and flu season fast approaching, nearly everyone is wondering whether we will endure another round of illnesses that will rival that of last spring.
Arimoclomol will be reviewed under Priority Review with a PDUFA date of March 17, 2021. Here’s more about it.