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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With the new approval, Rubraca becomes the first PARP inhibitor approved in a prostate cancer setting.
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Earlier this week, Sanofi’s chief executive officer Paul Hudson indicated that the U.S. would have first access to its COVID-19 vaccine because of the significant financial support it is receiving from the U.S. government.
Following a study that raises concerns about the accuracy of Abbott’s rapid COVID-19 test for detecting the virus, the U.S. Food and Drug Administration (FDA) announced it will investigate the claims found in a New York University-related study as the company updates its guidance on the ID NOW test.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 14, 2020.
Following the announcement that Slaoui was tapped to helm Operation Warp Speed, Jim Greenwood, president and CEO of BIO, hailed that decision.
Although many cyber criminals have pledged not to attack healthcare providers during the COVID-19 pandemic, one expert tells CNBC that this may not extend to pharmaceutical companies.
The designation will expedite regulatory review of the medication should it prove to be safe and effective.
This morning, the companies announced the regulatory agency issued a Refusal to File letter regarding the BLA for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pretreated relapsed and refractory multiple myeloma.