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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The FDA granted Moderna’s RSV vaccine candidate Breakthrough Therapy Designation Monday.
The FDA approved Eisai and Biogen’s lecanemab (Leqembi) Friday afternoon. It is the second anti-amyloid antibody to be approved for Alzheimer’s disease in two years.
BrainStorm Cell Therapeutics appoints a new co-CEO as it prepares for a January 11th Type A meeting for ALS hopeful NurOwn.
Amgen’s Repatha may cause cardiac harm, according to a reassessment of the biologic’s late-stage trial data.
Aurinia and Sun Pharma agree to file a joint motion to dismiss a key patent dispute.
Two documents recently came to light: first, the results of a congressional investigation into the approval of Aduhelm; second, a revised clinical trial consent form for lecanemab.
The U.S. Department of Justice indicted former CytoDyn Inc. CEO Nader Z. Pourhassan and the CEO of Amarex Clinical Research on multiple counts of fraud.
Verona Pharma’s COPD candidate hits the mark in late-stage testing.
The FDA placed a clinical hold on Entrada’s experimental DMD candidate.
The FDA lifted its partial clinical hold on bluebird’s experimental sickle cell disease gene therapy for patients younger than 18.