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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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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology Europe,
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