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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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BMS filed a patent infringement lawsuit against AstraZeneca over Imfinzi, while Guardant Health issued a statement in response to Illumina’s intellectual property lawsuit.
BMS achieved a monumental milestone when the U.S. Food and Drug Administration approved Opdualag (nivolumab and relatlimab-rmbw) for the treatment of melanoma.
Martin Shkreli will not be able to delay paying nearly $25 million he owes from a civil lawsuit that he and his company employed on Daraprim.
Although there is talk of a fourth shot of the COVID-19 vaccine the data so far suggest the benefits may be modest. Continue reading for details and more COVID-19 news.
A closer look at legal action against executives from the company formerly known as JHL Biotech who recruited scientists from Genentech to steal trade secrets related to several cancer drugs.
Sir Mene Pangalos said the company was considering not submitting it to the FDA if it finds it is “banging its head against a brick wall indefinitely.”
U.S. and Chinese regulators are edging toward a cooperation plan on Chinese companies that have stock listed on U.S. stock exchanges.
Alexion will pay Chugai $775 million in the second quarter of 2022 in exchange for the Japanese firm withdrawing the patent infringement lawsuits it filed in Europe, Japan and the U.S.
Tetra Bio-Pharma announced that its investigational new drug involving cannabinoids, QIXLEEF, received guidance to strengthen its nonclinical and toxicological data from the FDA.
Alnylam is suing Moderna and Pfizer over patent infringements related to its lipid techQnology that have been foundational to the success of the mRNA-based COVID-19 vaccines.