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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Johnson & Johnson secured more than $1 billion in additional funding for its COVID-19 vaccine research through an expansion of its partnership with the Biomedical Advanced Research and Development Authority.
Late Friday, the regulatory agency rejected the medication of sutimlimab due to deficiencies from a pre-license inspection of a third-party manufacturing facility.
Sanofi was formally charged over Depakine, its epilepsy drug, for not taking action when they first discovered the fetal risks when taken by pregnant women.
After months of urging the public to wear masks and facial coverings to help stop infected people from spreading COVID-19, the Centers for Disease Control and Prevention now states in newly released guidance that masks also protected the mask wearer from being infected.
Days after Pfizer and BioNTech announced their mRNA vaccine for COVID-19 demonstrated 90% efficacy at an interim analysis, Russia is claiming the vaccine it authorized in the fight against the novel coronavirus is 92% effective following an interim analysis of its ongoing Phase III study.
Several states have pledged to review COVID-19 vaccines themselves, after FDA emergency use authorizations, to ensure safety and efficacy. A robust review, however, is unlikely.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 10, 2020.
With the opinions that were expressed by the advisory committee, along with the data presented, the FDA will continue onward with its review process. It is expected to determine whether to approve the aducanumab Biologics License Application by March 7, 2021.
President-elect Joe Biden hit the ground running this morning with the announcement of his transition team’s COVID-19 advisory board.
Here’s a look at some of the upcoming target action dates on the U.S. FDA’s calendar.