EMA
Rasi nominated to be EMA chief
June 10, 2011Research and Development, Sales and Marketing EMA, Guido Rasi, Thomas Lönngren
The European Medicines Agency has nominated Italy’s Guido Rasi to be its next head, after a protracted and messy search. …
CHMP roundup
May 24, 2011Sales and Marketing CHMP, EMA, Fampyra, Vibativ, Victrelis, Xgeva, Yervoy
The latest products to be recommended for European approval include MSD’s Victrelis, Astellas Pharma Europe’s Vibativ, Amgen Europe’s Xgeva and …
EMA under fire from European Parliament
May 13, 2011Medical Communications, Research and Development, Sales and Marketing EMA, European Parliament, MEPs
The EMA has been hit by a barrage of criticism from the European Parliament over conflicts of interest and the …
FDA and EMA join forces on quality-by-design
March 22, 2011Manufacturing and Production EMA, FDA, QbD, Quality by Design, pharmaceutical marketing applications
The FDA has teamed up with the EMA on a new pilot programme that will allow parallel evaluation of marketing …
EMA road map to prioritise pharmacovigilance
January 28, 2011Research and Development, Sales and Marketing EMA, European Medicines Agency, pharmacovigilance
The European Medicines Agency is to prioritise issues such as pharmacovigilance over the next five years, while also looking closely …
Roche to challenge FDA on Avastin
December 21, 2010Sales and Marketing EMA, FDA, Roche, avastin, bevacizumab, breast cancer
Roche is set to challenge the decision by the FDA to remove a breast cancer indication from its blockbuster drug …
EMA to widen public access to documents
December 1, 2010Research and Development, Sales and Marketing EMA, European Medicines Agency, European Ombudsman, patient information, transparency
The European Medicines Agency has agreed to give greater access to documents on medicines for human and veterinary use, after …
Pfizer submits Gaucher drug to EMA
November 29, 2010Sales and Marketing Cerezyme, EMA, Gaucher disease, Genzyme, Pfizer, Protalix BioTherapeutics, Shire, Vpriv, taliglucerase alfa
Pfizer and partner Protalix BioTherapeutics have submitted a marketing application to European regulator the EMA for their Gaucher disease candidate …
Pharma engages HTA bodies in early-stage drug discussions
October 27, 2010Research and Development, Sales and Marketing Andrew Witty, AstraZeneca, EMA, European Medicines Agency, GlaxoSmithKline, Johnson & Johnson, health technology assessment, hta
Three pharma companies are taking part in a new pilot to harmonise European standards in health technology assessment (HTA). AstraZeneca, …
Shared API inspections project gains traction
October 26, 2010Manufacturing and Production API, EDQM, EMA, FDA, TGA, manufacturing compliance, pharma manufacturing, regulatory affairs, regulatory inspections
A three-way initiative between regulatory authorities in the EU, US and Australia on the inspection of facilities making active pharmaceutical …
Kinapse selected by European Medicines Agency to provide EudraVigilance data management services
October 25, 2010Business Services EMA, Kinapse
25 October, 2010 London, UK Kinapse announced today that it has been selected through a European open procurement procedure to …
Merck will appeal EMA’s Movectro decision
October 12, 2010Sales and Marketing CHMP, EMA, Merck KGaA, Merck Serono, Movectro
Merck KGaA is poised to appeal the EMA’s decision on its MS treatment Movectro after the regulator rejected the drug …
Patient group sponsorship and transparency criticised
August 16, 2010Sales and Marketing EMA, ethics, patient groups, transparency
High rates of sponsorship from pharma groups for patient groups have been criticised in a new report. The report from …
Digital Pharma: Byte-sized roundup
July 19, 2010Medical Communications Amgen, Digital Pharma blog, EMA, Sermo, digital doctors, google, psoriasis
This week’s roundup includes EMA’s new look website, a psoriasis patient group’s e-commerce venture, Amgen’s online patient empowerment competition, changes …
EMA sees fewer quality defects in ’09 inspections
June 9, 2010Manufacturing and Production API, EMA, manufacturing, manufacturing compliance
The European Medicines Agency carried out 175 inspections of manufacturing facilities in 2009, a little lower than its target, according …
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