Roche hopes its new drug Xofluza can pick up flu sales lost to Tamiflu generics. But it might end up competing with over-the-counter Tamiflu, too. Sanofi has snapped up Tamiflu's over-the-counter rights in the U.S., aiming to take the flu fighter to consumers without a prescription.
Kores (India) Ltd. Fails EDQM Inspection
Italian regulators say Kores Limited’s facility in Roha, India should be banned from supplying the API ambroxol hydrochloride to the EU and advised users to find an alternative source.
Anuh Pharma LTD fails EDQM Inspection
The European Commission (EC) has taken an European Union-wide legally binding decision and confirmed the favorable benefit/risk profile of ambroxol and bromhexine containing medicines. This decision follows the opinion of the Coordination Group for Mutual Recognition and Decentralized Procedures–Human (CMDh) as well as the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within the European Medicines Agency (EMA).
Sanofi is in exclusive talks to swap assets with Germany’s Boehringer Ingelheim GmbH in a 22.8 billion-euro ($25 billion) transaction that would be the largest for the French drugmaker in more than a decade.
Attix Pharmaceuticals Recalls Hundreds of APIs From the U.S.