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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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 8, 2020.
To date, 10 plasma companies globally have joined the CoVIg-19 Plasma Alliance, founded to accelerate development of a plasma-derived hyperimmune globulin therapy against COVID-19.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 7, 2020.
Developed by Novartis, the drug, Tabrecta, is designed for a type of NSCLC that has spread to other parts of the body and cannot be removed by surgery.
The CD19-directed chimeric antigen receptor (CAR) T cell therapy is a treatment for adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies.
The drug can potentially reduce the risk of cardiovascular death and hospitalization for heart failure.
Vaccine expert Rick Bright, who was abruptly dismissed from his post as director of the Biomedical Advanced Research and Development Authority (BARDA) last month, filed a whistleblower complaint against the administration over its failures to heed warnings about the COVID-19 pandemic and accused the White House of cronyism in awarding contracts.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 6, 2020.
The U.S. Federal Trade Commission gave the green light to the $63 billion merger of AbbVie and Allergan. That leaves one last hurdle for the two companies, approval from the Irish High Court.
In an interview with National Geographic, Fauci once again sided with the evidence that indicates the virus is a species jumper and originated in the animal kingdom.