EC

Showing 9 posts of 39 posts found.

Avastin

Roche gains new licence for blockbuster oncology drug

August 6, 2014
Research and Development, Sales and Marketing EC, Roche, avastin, ovarian cancer

Roche’s blockbuster cancer treatment Avastin now has a new European licence to treat women with a certain type of ovarian …

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Servier fined €331m by European Commission

July 10, 2014
Sales and Marketing EC, European Commission, France, Krka, Lupin, Matrix, Mylan, Niche/Unichem, Servier, Teva

The European Commission has served French pharma company Servier with a €331 million fine for delaying the entry to market …

EU regulator recommended 81 medicines in 2013

January 21, 2014
CHMP, EC, EU, FDA, US, rare diseases

Last year the Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for marketing approval, compared with just …

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EU publishes final GDP guidelines

March 19, 2013
Manufacturing and Production EC, EU, GDP

The European Commission has published the final version of its long-awaited guidelines on Good Distribution Practice (GDP), replacing an earlier …

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NICE hits back at ‘limited’ EC study

January 28, 2013
Sales and Marketing ABPI, EC, NHS, NICE, QALY, Whitehead

NICE has delivered a robust defence of the methods by which it arrives at a judgment on the value of …

EC publishes trio of revised GMP Guide sections

September 24, 2012
Manufacturing and Production EC, EU, GMP, ICH

The European Commission has published two revised chapters in its Good Manufacturing Practice (GMP) Guide, along with an update of …

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Changes to patient information in Europe

February 23, 2012
Medical Communications, Sales and Marketing Commission, EC, ED, parliament

European authorities have made new proposals to allow pharma to communicate with patients and the public  – but a ban …

Europe wants regulatory reform over PIP implant scandal

January 16, 2012
Manufacturing and Production, Sales and Marketing EC, MHRA, PIP implants

The European Commission is seeking regulatory reform for class III medical devices after problems with French-made breast implants. The French …

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Digital Pharma: E-Health and the European agenda

November 19, 2010
Medical Communications Digital Agenda, Digital Pharma blog, EC, European Commission, Neelie Kroes, digital patients, e-health, electronic patient records

The European Commission wants all European patients to be given secure online access to their medical records by 2015 and …

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