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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Zejula, GlaxoSmithKline’s once-daily PARP inhibitor, won regulatory approval as a monotherapy maintenance treatment for women with advanced ovarian cancer whose disease is responsive to first-line platinum-based chemotherapy, regardless of biomarker status.
Shares of Eagle Pharmaceuticals and Teva Pharmaceuticals are climbing following a favorable ruling in U.S. District Court that protects the patent for cancer drug Bendeka from generic competition through 2031.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 29, 2020.
The U.S. Food and Drug Administration approved an additional recommended dosage of 400 mg every six weeks for the anti-PD-1 therapy across all adult indications, including as a monotherapy and in combination treatments.
Neurocrine Biosciences announced on Monday that it has received approval from the U.S. Food and Drug Administration for its once-daily oral drug, Ongentys, as an add-on treatment to levodopa/carbidopa for the treatment of Parkinson’s disease.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 28, 2020.
Here is a cross-section of some of the surveys about the COVID-19 pandemic over the last few weeks.
Many of the tests that are available are giving false-positives, which means that some people who have not been exposed to COVID-19 are under the impression they have been.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 27, 2020.
Gilead Sciences filed a lawsuit against the United States government alleging the U.S. Centers for Disease Control and Prevention violated a contract that governed an HIV research collaboration between the company and government agency.