Teva Catches A Break On Copaxone 40mg, But For How Long?
Executive Summary
An FDA warning letter cites deficiencies at the Pfizer-owned manufacturing facility poised to produce a Momenta/Sandoz generic competitor. It’s unclear how long Pfizer might take to resolve the violations, which include particulates in finished products.
You may also be interested in...
Sandoz's Less Frequently Dosed Copaxone Generic Glatopa Hits Teva Two Months Early
Teva said its 2018 revenue guidance reflected an April launch for the 40 mg dose of Glatopa, but Sandoz and partner Momenta announced FDA approval and the US launch of their less frequently administered Copaxone generic on Feb. 13.
Sandoz's Less Frequently Dosed Copaxone Generic Glatopa Hits Teva Two Months Early
Teva said its 2018 revenue guidance reflected an April launch for the 40 mg dose of Glatopa, but Sandoz and partner Momenta announced FDA approval and the US launch of their less frequently administered Copaxone generic on Feb. 13.
Pharma Q4 Results Preview: Bristol, Allergan, Gilead, GSK, Sanofi, Teva
Hemophilia and immuno-oncology will be in the spotlight as earnings season continues into February. Will Bristol be a buyer or an acquisition target? How will Sanofi fare with its new acquisitions? And how will Teva and GSK fare as they face generics for top brands?