Parties have already agreed to sell more than 50 products so far, but are still extending outside date for closing of Teva's acquisition of Allergan's generic business until October.
While Teva Pharmaceutical Industries Ltd. expects the Federal Trade Commission to approve its acquisition of Allergan PLC's generic business any day, the parties extended the outside date for the closing from July 26 to Oct. 26. Since the companies have already agreed to divest more than 50 products, the FTC may not require them to sell off additional assets.
In a July 13 filing with the Securities and Exchange Commission, Teva reported that it had entered into a third...
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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