Pharma Conversation & Community
A round up of news from across the web, including trends from social social media platforms.
HITTING THE HEADLINES
FDA Issues Draft Guidance on Electronic Submissions
FDA has issued a draft guidance, Guidance for Industry: Providing Submissions in Electronic Format—Summary Level Clinical Site Data for CDER's Inspection Planning, which is one in a series of documents intended to assist sponsors and applicants making certain regulatory submissions to FDA in electronic format.
PharmTech.com/ElectronicGuidance
US Supreme Court to Hear Pay-for-Delay Case
The US Supreme Court agreed to hear a case that will decide whether brand-name drug companies may pay generic drug-companies to delay introduction of lower-cost generic drugs. The Supreme Court is to review a federal appeals court ruling that upheld a "pay-for-delay" arrangement.
Ranbaxy Recalls Atorvastatin Due to Quality Issues
Ranbaxy Pharmaceuticals is recalling certain lots of its atorvastatin tablets because of possible contamination with small glass particles (less than 1 mm in size). Ranbaxy has ceased atorvastatin manufacturing until it has thoroughly investigated the problem.
INDUSTRY M&As
- Valeant Pharmaceuticals International has completed its acquisition of Medicis Pharmaceutical.
- Isochem has expanded its range of intermediates by acquiring the British fine-chemicals company, Wychem.
- French contract manufacturing firm Synerlab has acquired lyophilization specialist company Lyofal.
- Amgen has agreed to buy Icelandic-based Decode Genetics for $415 million in an all-cash transaction.
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