Policy
Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.
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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Burjeel Holdings and BridgeBio Pharma ink partnership deal in rare genetic diseases with a plan to set up headquarters in Abu Dhabi.
The European Medicines Agency has widened its review of potential suicide risks associated with GLP-1 receptor agonists. The probe, which started July 3, is expected to conclude in November.
The biotech Monday announced a clinical hold on its HEMO-CAR-T candidate, which is being trialed for the treatment of acute myeloid leukemia, due to manufacturing concerns cited by the regulator.
The biotech will supply Canada with fewer doses of its coronavirus vaccine while reaching a financial agreement for the forfeiting of certain doses previously scheduled for delivery.
After an initial series of legal complaints in June, Novo Nordisk filed four new lawsuits Thursday against Florida and Tennessee pharmacies for allegedly selling products containing semaglutide.
Following the FDA’s full approval of the Alzheimer’s drug Thursday, the Centers for Medicare and Medicaid Services confirmed broader coverage of Leqembi and released more details on a registry.
Thursday, Eisai and Biogen’s Leqembi also became the first disease-modifying treatment for Alzheimer’s to win traditional approval. CMS coverage is expected to begin immediately.
The European Medicines Agency recently flagged a safety signal related to GLP-1 receptor agonists and sent a list of questions to manufacturers including Novo Nordisk, Eli Lilly, Sanofi and AstraZeneca.
Citing insufficient safety evidence for one of the drug’s main ingredients, the regulator in a Complete Response Letter rejected the company’s application for Parkinson’s disease candidate IPX203.
The companies have filed their own suit against the Federal Trade Commission, claiming the FTC’s attempt to legally block their $28 billion merger is unconstitutional.