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Pharmaceutical Technology Europe
Volume 24, Issue 8

News bites

Investigation at Roche

The EMA has launched an investigation into Roche after an inspection found that thousands of potential safety reports, including 15161 deaths, connected to Roche medicines had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions.
http://www.pharmtech.com/RocheReporting

GSK Pleads Guilty

GlaxoSmithKline has agreed to plead guilty and pay $3 billion (2.4 billion Euros) to resolve criminal and civil liability resulting from the unlawful promotion of certain drugs, failure to report safety data and alleged false price reporting practices. According to the Justice Department, it is the largest healthcare fraud settlement in US history.
http://pharmtech.com/GSkGuilty

US Healthcare Reform

The US Supreme Court has upheld the provision of the country's Affordable Care Act. Among other points, the decision means that FDA can continue to implement the new biosimilars programme. Implementation of US reform now depends on who controls the White House and Congress after the elections, as well as individual states implementing the law.
http://www.pharmtech.com/USReform

Merck Restructuring

Merck Serono has revealed its "final efficiency program" for operations in Switzerland, which includes confirmation of the closure of sites in Geneva and Coinsins. The majority of job transfers and cuts are expected to be completed later this year. Closure of the Geneva site is planned for mid-2013 and for 2014 for the Coinsins site.
http://www.pharmtech.com/MerckPlans


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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
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
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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 Europe,
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