Policy
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
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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The COVID-19 pandemic is changing the FDA irrevocably, resulting in a more dynamic, streamlined FDA that is more willing to embrace digital technology, according to panelists at the recent OC LIFe (Lifesciences Innovators Forum) virtual presentation, “COVID-19: Changes In FDA Approval & Clearance Processes.”
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 2, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 31, 2020.
On Sunday, U.S. Food and Drug Administration Commissioner Stephen Hahn told the Financial Times that he would potentially fast-track a COVID-19 vaccine before clinical trials are done if it was “appropriate.”
EcoHealth had already developed a partnership with a WIV laboratory in Wuhan, China, under a five-year NIH grant. It was expected to run through 2024 but was canceled in April.
One day after Abbott secured Emergency Use Authorization for its $5 coronavirus test, the White House awarded the company a $750 million contract to deliver 150 million Abbott BinaxNOW COVID-19 Ag Card Point of Care (POC) SARS-CoV-2 diagnostic tests.
With a new regulatory approval in hand for its FoundationOne Liquid CDx, Foundation Medicine said it plans for the product to be available for commercial use by Friday, Aug. 28.
The U.S. Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi. Let’s look at how this new acne treatment was developed.
The U.S. Department of Justice charged the Israel-based company with three counts of fixing prices to reap more than $350 million from customers through the scheme.
“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” Hahn tweeted. “The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”