EMA
Act now – or risk running out of time for IDMP
February 23, 2015Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, Eversheds, ISO, icsr, idmp, regulatory
Many people in pharma would argue that the world of regulatory compliance in the life sciences industry is already complicated …
EMA launches consultation on clinical trials
January 22, 2015Research and Development, Sales and Marketing EFPIA, EMA, EU, Europe, Goldacre, alltrials, transparency
The European Medicines Agency has invited pharma to comment on its proposals to ramp up transparency in the industry and …
UCB epilepsy drug reaches regulatory bodies
January 21, 2015Research and Development, Sales and Marketing EMA, FDA, UCB, brivaracetam, epilepsy
UCB has established regulatory milestones for its investigational antiepileptic drug brivaracetam in Europe and the US. The Food and Drug …
Regulators ‘more efficient at approving drugs’
January 19, 2015Research and Development, Sales and Marketing EMA, EMA), FDA, Health Canada, PMDA)., Pharmaceutical and Medical Devices Agency, Swissmedic, TGA, approvals, cirs, reuters
Global regulatory bodies have become faster at approving new drug products more quickly and consistently, according to a new analysis …
EMA ramps up adaptive pathways pilot
December 23, 2014Manufacturing and Production, Research and Development, Sales and Marketing EMA, adaptive pathways, drugs, regulator
Six medicines have been selected to move to the next stage of the EMA’s adaptive pathways pilot project, to explore …
Chiesi gets first-ever European stem cell nod
December 19, 2014Sales and Marketing Chiese, Chiesi, EMA, Holoclar, LSCD, MHRA, Stem cells, orexigen
Chiesi has received the first approval for an advanced therapy medicinal product containing stem cells for use in Europe. The …
Adaptive licensing could ‘transform industry’
December 17, 2014Research and Development, Sales and Marketing Clinical Pharmacology & Therapeutics, EFPIA, EMA, MHRA, adaptive licesning
Drug regulators should switch to adaptive pathways as the preferred approach to bringing future new medicines to patients, according to …
Bayer files haemophilia drug in EU
December 5, 2014Sales and Marketing BAY 81-8973, Bayer, Biogen IDEC, EMA, elocta, haemophilia a, kogenate
Bayer has submitted a marketing authorisation application to the EMA for its haemophilia A therapy BAY 81-8973. The German firm’s …
EMA discussing executive director post
December 3, 2014Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, Guido Rasi, andreas pott
The European Medicines Agency has confirmed that Andreas Pott will remain in charge of the body in place of the …
CHMP nods several drugs through
November 24, 2014Sales and Marketing Boehringer, CHMP, EMA, Esbriet, FDA, Sanofi, nintedanib, ofev
Ten new medicines have been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP), among …
European Medicines Agency appoints admin lead
November 18, 2014Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, Luc Vanheel, admin
Luc Vanheel has joined the European Medicines Agency (EMA) as the head of its administration division. A Belgian national, Vanheel …
EMA in turmoil as top job ‘annulled’
November 17, 2014Sales and Marketing EC, EMA, EU, Europe, Guido Rasi, Rasi, transparency
The future of Guido Rasi, head of Europe’s drugs regulator, is up in the air after a legal ruling which …
EMA responds to redaction concerns
November 14, 2014Sales and Marketing AbbVie, EMA, Goldacre, Humira, Rasi, adalimumab, redactions, transparency
The EMA has published a response to European Ombudsman Emily O’Reilly’s questions about some of its trial data redactions. O’Reilly’s …
Scenesse recommended for rare sun disease in Europe
October 27, 2014Sales and Marketing CHMP, Clinuvel Pharmaceuticals, EMA, EU, scenesse
The European Medicines Agency is recommending that Scenesse (afamelanotide) be approved for the prevention of severe sun burn in adults …
EMA keeps Ariad cancer drug on the market
October 13, 2014Sales and Marketing Ariad, CML, EMA, PRAC, iclusig, leukaemia, ponatinib
The EMA has recommended Ariad’s leukaemia drug Iclusig (ponatinib) should continue to be used under its current indication despite ongoing …
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