EC
Roche gains new licence for blockbuster oncology drug
August 6, 2014Research 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 …
Servier fined €331m by European Commission
July 10, 2014Sales 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, 2014CHMP, 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 …
EU publishes final GDP guidelines
March 19, 2013Manufacturing 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 …
NICE hits back at ‘limited’ EC study
January 28, 2013Sales 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, 2012Manufacturing 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 …
Changes to patient information in Europe
February 23, 2012Medical 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, 2012Manufacturing 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 …
Digital Pharma: E-Health and the European agenda
November 19, 2010Medical 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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