Geneva Augmentin generic reserve: Geneva's generic amoxicillin/clavulanate earnings are being placed in a reserve in the event the company loses GlaxoSmithKline's appeal of the Augmentin patent lawsuit, Novartis CEO Daniel Vasella said July 22. "We will book sales, but we will not book the earnings out of this product but put them in a reserve," the exec said. "The additional exposure should we - against all odds - lose the appeal next year, would be an amount which we can digest, I would say, rather easily." GSK is appealing a May 22 ruling in Geneva's favor; a decision could come as early as January (1"The Pink Sheet" May 27, p. 20). Geneva launched amoxicillin generics in June...
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.
