Regulatory
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.
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.
Innovent and Lilly expect Halpryza to be a high quality and slightly more affordable rituximab injection for a market experiencing serious needs.
AstraZeneca signed a deal with Operation Warp Speed, the U.S. government program to advance COVID-19 vaccines and therapeutics, for a monoclonal antibody cocktail.
Although the Phase III trial for the Tramadol demonstrated statistically significant outcomes for all of the primary and many secondary endpoints, the FDA rejected the application.
Moncef Slaoui, the head of Operation Warp Speed, suggested the first Emergency Use Authorization for a COVID-19 vaccine will likely be around Thanksgiving.
Shares of Alkermes were up more than 12% in pre-market trading after the Ireland-based company announced late Friday that its schizophrenia drug ALKS 3831 was overwhelmingly supported by an advisory committee for the U.S. Food and Drug Administration.
The assessment does point to a path for approval, however FDA staff do raise some concerns about the fact that the drug’s makeup includes an opioid antagonist.
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