Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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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.
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.