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FDA Issues Draft Guidance on Electronic Submissions

FDA has issued a draft guidance, Guidance for Industry: Providing Submissions in Electronic Format—Summary Level Clinical Site Data for CDER's Inspection Planning, which is one in a series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

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.