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FDA Issues Draft Guidance on Electronic Submissions
FDA has issued a draft guidance, Guidance for Industry: Providing Submissions in Electronic Format—Summary Level Clinical Site Data for CDER's Inspection Planning, which is one in a series of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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ON THE BLOG
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MOST TWEETED
- Pharma companies using new analytical methods to ensure quality of medicine ht.ly/g0oIm
- How to optimize continuous processing and make it work in pharmaceutical manufacturing is a crucial issue. ht.ly/g4AtD
Clinical Supply Planning in Europe - Balancing Cost, Flexibility and Time
December 19th 2024The packaging and distribution of clinical supplies is a fundamental piece to the overall success of a clinical trial, and advance preparation can help establish a more efficient supply chain. Selecting the best geographical location for those activities, however, depends on the clinical trial protocol, business decisions, and even the investigational medicinal product (IMP) being studied.
