Pharma Conversation & Community

A round up of news from across the web, including trends from social social media platforms.
Jan 02, 2013

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FDA Issues Draft Guidance on Electronic Submissions

FDA has issued a draft guidance, Guidance for Industry: Providing Submissions in Electronic Format—Summary Level Clinical Site Data for CDER's Inspection Planning, which is one in a series of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.

http://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.

http://PharmTech.com/SupremeCourt

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.

http://PharmTech.com/RanbaxyRecall

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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