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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Regeneron announced that the U.S. Food and Drug Administration approved Inmazeb, a three-antibody cocktail to treat Ebola infections in adults and children.
This week, the judge overseeing her trial denied all efforts from her legal team to dismiss more than a dozen criminal charges against the Theranos founder.
With multiple COVID-19 vaccines in development, the CDC is confident that any vaccines the FDA authorizes or approves will be safe because they are based on the FDA’s usual stringent protocols. The greater question, after a vaccine is approved, is how it will be distributed.
Mallinckrodt has filed for Chapter 11 bankruptcy amid growing lawsuits that allege the company has participated in fueling the opioid epidemic in the United States.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 13, 2020.
NASH is a metabolic disease similar to cirrhosis of the liver, but occurs in people who drink little, if any, alcoholic.
The FDA placed the hold onto the program hold pending the resolution of certain chemistry, manufacturing and controls (CMC) matters, Voyager said.
Charles M. Lieber is currently on paid leave from Harvard’s chemistry department after his arrest in January on charges of lying to the U.S. government about funds received from China.
Innovent and Lilly expect Halpryza to be a high quality and slightly more affordable rituximab injection for a market experiencing serious needs.
A 41-year-old man from Richland, Wash. was convicted on 47 counts of fraud and drug related charges on Oct. 1, according to the U.S. Justice Department’s Eastern District of Washington.