Government
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.
The U.S. FDA placed a hold on the Emergency Use Authorization for convalescent plasma as a potential treatment for COVID-19 over what was described as a lack of robust data supporting its use.
“We are grateful to the NIA for their rigorous scientific review and funding support to advance ALZ-8801 for Alzheimer’s patients in need of an effective treatment,” said Martin Tolar, founder, president and chief executive officer of Alzheon.
The agency indicated that they had completed the review cycle for the application but the application was not ready for approval in its current form.
The company indicates the agency requested data from the MANTA and MANTA-Ray trials before completing its review of filgotinib. Here’s more about it.
This morning, Mylan announced the launch of its new generic offering, dimethyl fumarate delayed-release capsules for the treatment of relapsing forms of multiple sclerosis.
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