As the new Supreme Court term begins, PhRMA and a host of biopharma CEOs and investors implore justices to take up mifepristone case to prevent chaos for drug development. High court will also consider a lawsuit that would reduce deference to federal rulemaking and it may consider another that would increase corporate liability under the Anti-Terrorism Act.
The US Supreme Court is set to hear one case this term that could bolster the biopharma industry’s ability to challenge US Food and Drug Administration rules and it is likely to take up another case that would undermine industry's reliance on agency decisions.
The biopharmaceutical industry is in FDA's corner in the latter litigation, in which the Alliance for Hippocratic Medicine, a group...
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.
Glenmark Pharmaceuticals agreed to pay $25m in the US to resolve its alleged liability under the False Claims Act linked to price-fixing allegations.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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