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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.
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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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Between J&J, Purdue ($270 million), and Israel-based Teva Pharmaceuticals ($85 million), Oklahoma will garner about $927 million – a far cry from the $20 billion the state had been seeking in damages related to the opioid crisis.
Adocia announced that the American Arbitration Association Tribunal governing Adocia’s arbitration claims against Eli Lilly & Company dismissed both parties’ claims in the second and final phase of the arbitration between Adocia and Lilly.
Leaders from across the pharmaceutical industry are decrying negative actions taken by government agencies and universities against Chinese researchers in the United States.
Eli Lilly won an arbitration hearing over accusations the Indianapolis-based company misused confidential information regarding the intellectual property of its former business partner, France-based Adocia S.A.
More Women May Benefit from Hereditary Cancer Risk Assessment and Genetic Testing
Novo Nordisk filed a lawsuit in a Delaware district court against generic drugmaker Mylan. The suit is an attempt to block Mylan from marketing a generic version of Novo Nordisk’s diabetes drug Victoza.
Some have wondered why the agency has hit back at Novartis so hard when the data in question didn’t have any effect on the eventual outcomes of the product’s effectiveness and safety.
Motif Bio plc announced that the Company will be utilising NIAID’s1 suite of preclinical services through JMI Laboratories to evaluate iclaprim against Listeria monocytogenes, a Gram-positive bacteria causing food-borne, life-threatening infections.
Philadelphia, PA – Oncoceutics, Inc., announced that it has signed an exclusive, world-wide license for US patent #10,239,877, entitled “Pharmacophore for trail induction”, from The Scripps Research Institute, covering the composition of matter of ONC201 as well as other molecules in the imipridone family.
The regulatory agency expressed concern regarding the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models of golodirsen and observed following administration of other antisense oligonucleotides, Sarepta said.