Trial opens after settlement proposals by three distributors, Teva and J&J fail to gain support of cities and counties. Distributors want to call former FDA Commissioner Kessler to testify over plaintiffs' objections. Judge rules plaintiffs cannot seek future damages.
The long-awaited bellwether trial to determine if drug manufacturers, distributors and pharmacies are culpable in the opioid epidemic and how much they should pay to cover the costs borne by cities and counties begins on 21 October as the parties fail to reach an agreement on proposed settlements.
The litigation is unprecedented in its size and scope and the intense scrutiny it has placed on industry's actions as...
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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