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Restructure at Merck KGaA

Merck KGaA has announced measures to reduce costs and increase efficiency to ensure the long-term success of its business model. The measures are expected to result in workforce reductions across all businesses and regions. The measures will be implemented in two phases.
http://PharmTech.com/merckrestructure

GSK recall

GSK recently recalled 394230 bottles of its antihypertensive drug DynaCirc CR (isradipine) controlled-release tablets. The lots were recalled due to concerns regarding the level of cGMP compliance and procedural controls related to line clearance during the packing process at a US-based facility of Novartis Consumer Health, where the product was made.
http://PharmTech.com/gskrecall

FDA's DTC guidance

The FDA has released a draft guidance for direct-to-consumer (DTC) television advertisements in the US. Companies will have to submit their TV ads for FDA review at least 45 days before dissemination. After reviewing, the FDA can recommend changes to protect consumers or to be more consistent with prescribing information.
http://PharmTech.com/TVads

Japanese vaccine venture

GlaxoSmithKline and Daiichi Sankyo have formed a joint venture hey claim will create the biggest vaccines company in Japan. The joint venture will seek to improve access to vaccinations in Japan, as well as introduce new vaccines and create better and more convenient combination vaccines. The new company will be called Japan Vaccine Co., Ltd.
http://PharmTech.com/JPvaccines


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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
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
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 Europe,
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