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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Retrophin, Inc. reported its second quarter 2019 financial results and provided a corporate update.
Despite the data concerns, the U.S. Food and Drug Administration said it believes the gene therapy should remain on the market. Novartis said it stands behind the safety and efficacy of the therapy.
Oxford Immunotec Global PLC, or the Company, a global, high-growth diagnostics company, announced second quarter 2019 financial results.
Pratteln, Switzerland, August 2, 2019 – Santhera Pharmaceuticals announces the closing of the licensing transaction with Chiesi Farmaceutici, an international research-focused healthcare group.
Ultragenyx Pharmaceutical Inc. reported its financial results and corporate update for the quarter ended June 30, 2019.
Supporting rare disease diagnosis, education, and clinical research
Ultragenyx Pharmaceutical Inc. announced that it has submitted to the U.S. Food and Drug Administration a New Drug Application for UX007 for the treatment of long-chain fatty acid oxidation disorders, a group of genetic disorders in which the body is unable to convert long-chain fatty acids into energy.
Neos Therapeutics, Inc. announced that it will report its second quarter 2019 financial results prior to the opening of U.S. financial markets on Thursday, August 8, 2019.
Singapore scientists and clinicians have discovered a promising use of antibodies to target a new cancer antigen, as an alternative for chemotherapy
Although the lawsuits over who owns the rights to gene editing technique CRISPR seemed to be mostly settled in September 2018, a recent dispute between the University of California and the Cambridge, Massachusetts-based Broad Institute suggested the battles aren’t done yet.