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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