A recent opinion from an EU advocate general is another blow for Roche and Novartis in their fight against an Italian fine imposed on them as a result of their agreement on the use of Avastin and Lucentis in wet AMD. If the opinion is followed by the court, it could have competition law consequences in areas such as product licensing.
An advocate general of the Court of Justice of the EU has said that a medicinal product used for an unapproved off-label indication can be considered to be a competitor in the same market as another product that is authorized for that same use.
The opinion, delivered by Henrik Saugmandsgaard Øe on Sept.21, should be of great interest to biopharmaceutical companies wanting...
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.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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.
