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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Expected to launch in June or July, the study plans to test as many as 325,000 people to learn how the SARS-CoV-2 virus is spreading nationally, according to Reuters, reporting before the official announcement.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 19, 2020.
The approval was based on interim analysis from the company’s Phase III IMpower110 trial.
With the new approval, Rubraca becomes the first PARP inhibitor approved in a prostate cancer setting.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 18, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 15, 2020.
Earlier this week, Sanofi’s chief executive officer Paul Hudson indicated that the U.S. would have first access to its COVID-19 vaccine because of the significant financial support it is receiving from the U.S. government.
Following a study that raises concerns about the accuracy of Abbott’s rapid COVID-19 test for detecting the virus, the U.S. Food and Drug Administration (FDA) announced it will investigate the claims found in a New York University-related study as the company updates its guidance on the ID NOW test.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 14, 2020.
Following the announcement that Slaoui was tapped to helm Operation Warp Speed, Jim Greenwood, president and CEO of BIO, hailed that decision.