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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In the latest legal action, the attorneys general from 46 states, the District of Columbia and four U.S. territories accused the drug makers of conspiring to rig the price of approximately 80 generic drugs between 2009 and 2016
In an interview this morning with CNN, Dr. Anthony Fauci said the government will help finance Phase III studies of three vaccine candidates.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 10, 2020.
Charles Lieber, the former chair of Harvard University’s Chemical Biology Department, was indicted by a federal grand jury this week on two counts of making false statements.
Fauci, a longtime infectious disease expert, said COVID-19 is the stuff of nightmares in the way it has quickly spread across the globe, infected millions of people and contributed to the deaths of more than 408,000 people.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 8, 2020.
The next two weeks are busy ones for the U.S. Food and Drug Administration (FDA). Here’s a look at PDUFA dates for this period.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 5, 2020.
“We are genuinely honored at the opportunity to protect our military personnel and their families who have devoted themselves to the needs of U.S. citizens and others worldwide,” said Stanley C. Erck, president and chief executive officer of Novavax.
Inovio’s development issues for its vaccine candidate have become mired in a conflict with the contract manufacturing organization it has worked with on previous projects.