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Pharma Conversation & Community
A round up of news from across the web, including trends from social social media platforms.


Pharmaceutical Technology
Volume 37, Issue 1

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FDA Issues Draft Guidance on Electronic Submissions

FDA has issued a draft guidance, Guidance for Industry: Providing Submissions in Electronic Format—Summary Level Clinical Site Data for CDER's Inspection Planning, which is one in a series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

SEEKING INPUT

PharmTech is seeking reader input for a future feature on parenteral drug manufacturing. Send your questions and thoughts to the Community Manager, Stephanie Sutton, at
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ON THE BLOG

"Real-time devices for continuous feeding processes were discussed at a seminar I recently attended."

Jennifer Markarian, http://PharmTech.com/RealTime

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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

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
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View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
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