Members of the European Parliament have significantly watered down plans for a cut to regulatory data protection, but industry says the net effect of the proposals will still be to make Europe “less competitive and less attractive” to investment in innovation.
Plans to overhaul the EU’s medicines legislation took a major step forward on 19 March when a European Parliament committee voted to approve the “pharmaceutical package” published by the European Commission in April 2023, albeit with some major changes to the proposals on regulatory data protection (RDP).
As part of a set of compromise amendments intended to reconcile opposing political positions on the proposals, the parliament’s environment...
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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