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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The designation will provide for an expedited pathway for regulatory review of the preventative medication, which could come later this year.
The U.S. Food and Drug Administration issued a Complete Response Letter to Merck and Eisai over their Lenvima and Keytruda combination for first-line treatment of unresectable hepatocellular carcinoma (HCC).
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 10, 2020.
The National Institute of Allergy & Infectious Diseases (NIAID) has founded a new clinical trials network focused on enrolling volunteers in clinical trials for COVID-19 vaccines and monoclonal antibodies.
The submission was completed with ongoing collaboration with the FDA and include data from the Phase III EMERGE and ENGAGE trials, as well as the Phase Ib PRIME study. Biogen has also requested Priority Review.
On Tuesday, the White House notified Congress and the United Nations of the decision. However, the withdrawal will not be immediate.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 8, 2020.
This deal with BARDA and the DoD supports continuing the manufacturing in order for it to be immediately available in the U.S. if the clinical trials are successful.
Novavax said the funding will allow the company to participate in Operation Warp Speed, the government’s program that has a goal of supporting the development of hundreds of millions of vaccine doses by 2021.
Cellectis, based in Paris and New York, announced that the U.S. Food and Drug Administration (FDA) had placed a clinical hold on its MELANI-01 trial.