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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The Centers for Medicare and Medicaid Services on Thursday sent its opening price proposals to drugmakers, which now have 30 days to either approve the offers or submit counteroffers.
During a Wednesday webinar, FDA Commissioner Robert Califf said the agency is working on “systemic” changes to its advisory committee process.
The first hearing on a potential injunction came the day before CMS is to release pricing proposals on 10 drugs.
The Inflation Reduction Act’s Drug Price Negotiation Program will erode only a small portion of global biopharma revenues and is unlikely to cause significant cuts to research and development, find researchers.
The Centers for Medicare and Medicaid Services will enter talks with manufacturers to come up with a pricing and rebate scheme that will tie the gene therapies’ cost with their effectiveness.
Defender Pharmaceuticals on Tuesday did not reveal the reasons for the regulator’s rejection of its nasal gel version of scopolamine. The company is seeking a meeting with the FDA to “understand the issues.”
Ascidian Therapeutics, a member of BioSpace’s NextGen Class of 2024, on Monday announced it received IND clearance from the FDA and was granted Fast Track designation for ACDN-01.
The FDA has granted Priority Review for AstraZeneca and Daiichi Sankyo’s supplemental BLA for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors.
The Centers for Medicare and Medicaid Services’ initial proposed drug price cuts, due to pharma companies by Thursday under the Inflation Reduction Act, could range from 25% to 60%, analysts told Reuters.
The CEOs of J&J and Merck have finally committed to testifying before the Senate health committee regarding the high prices of drugs in the U.S. The hearing is set for Feb. 8.