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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David Loew, head of Sanofi Pasteur, said U.S. approval of the vaccine is an important milestone in the fight against meningococcal meningitis, a serious global health challenge that can be fatal within 24 hours.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 24, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 23, 2020.
In a statement to the New York Times, Bright said he has pushed for science, not politics, as the key to battling the pandemic.
The FDA recently approved the combination of Imbruvica-Rituximab for treating chronic lymphocytic leukemia. Here’s everything you need to know.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 22, 2020.
After leading a flurry of collaborations with multiple companies to hasten the development of vaccine candidates and treatments for COVID-19, Rick Bright, the director of BARDA, has abruptly departed his post for another position in the government.
Futura Medical plc, a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® technology and currently focused on sexual health and pain, is pleased to announce that it has now filed for a further pre-submission meeting with the US FDA following receipt of the complete and signed clinical study report for its Phase 3 Study.
It does not require healthcare workers and first responders to conduct the test using personal protective equipment. Therefore, it should prevent the risk of transmitting the virus.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 21, 2020.