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 U.S. Department of Justice charged the Israel-based company with three counts of fixing prices to reap more than $350 million from customers through the scheme.
“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” Hahn tweeted. “The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 26, 2020.
Tricida plans to request a Type A meeting with the FDA, which is expected to take place in the fourth quarter of this year. This meeting will decide the future of veverimer.
There are several China-based companies that have vaccine candidates in Phase III.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 24, 2020.
According to a report, three people briefed on the plan indicated Trump wants to give AstraZeneca and the University of Oxford’s experimental COVID-19 vaccine emergency use authorization ahead of the U.S. presidential election on November 3.
The U.S. FDA reversed itself Sunday following pressure from the White House and announced an Emergency Use Authorization for convalescent plasma as a treatment for patients who have contracted COVID-19.
August has been a busy month for the U.S. Food and Drug Administration. The final two weeks are marked by a number of PDUFA dates, although a few of those drugs have already been approved.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 21, 2020.