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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.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 6, 2020.
It’s a relatively slow month ahead for July in terms of PDUFA dates for the U.S. FDA. However, there are several dates pending throughout the month. Here’s a look at three for the next two weeks.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 3, 2020.
The U.S. Justice Department charged Glenmark Pharmaceuticals, headquartered in India, with conspiring with other generic drug companies to increase and hold prices for the cholesterol drug pravastatin between May 2013 and December 2015.
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