EMA
Regulators produce QbD report
August 28, 2013Manufacturing and Production, Sales and Marketing EMA, FDA, QbD
European and US regulators have published the first fruits of their collaboration on assessing measures to ensure drugs are manufactured …
Doctor questions FDA’s diet drug approvals
August 23, 2013Research and Development, Sales and Marketing BMJ, Belviq, EMA, FDA, Vivus, diet pills, obesity
GSK seeks licence extensions
August 8, 2013Sales and Marketing Cervarix, EMA, GSK, Votrient
GlaxoSmithKline is seeking to extend the licences of two of its brands, Cervarix and Votrient, in a bid to extend …
EMA: no cancer risk from GLP-1s
July 29, 2013Research and Development, Sales and Marketing Cancer, EMA, GLP-1s
One of the European Medicines Agency’s key advisory groups has decided that concerns over an increased cancer risk with some …
Secret EFPIA memo on data transparency leaked
July 22, 2013Medical Communications, Research and Development, Sales and Marketing ABPI, EFPIA, EMA, PhRMA, transparency
A memo from the European pharma lobby group EFPIA has revealed that the industry is trying to ‘mobilise’ patient groups …
Court overturns orphan refusal
July 10, 2013Sales and Marketing EMA, laboratoires ctrs, orphacol
A European Commission decision last year to refuse marketing authorisation for an orphan drug has been overturned by a major …
ICON appoints chief medical officer
July 4, 2013Manufacturing and Production, Research and Development, Sales and Marketing EMA, ICON, buckley
Clinical research organisation ICON has confirmed the appointment of Professor Brendan Buckley as chief medical officer. Buckley will be ICON’s …
EMA ponders biosimilar guideline
May 14, 2013Research and Development, Sales and Marketing EMA, biosimilars
The European Medicines Agency is thinking about changes to its guidance on similar biological medicines and has published a draft …
Court rules against EMA disclosure
May 2, 2013Medical Communications, Research and Development, Sales and Marketing AbbVie, EMA, Roche, transparency
The European Medicines Agency (EMA) has been ordered in an interim ruling by the General Court of the European Union …
GSK submits UMEC monotherapy
April 29, 2013Sales and Marketing COPD, EMA, GSK, UMEC
GlaxoSmithKline has put its investigational once-daily medicine umeclidinium bromide (UMEC) up for scrutiny by European regulators for patients with chronic …
EMA launches ‘black triangle’ post-marketing scheme
April 28, 2013Sales and Marketing EMA, Post-marketing surveillance, black triangle, pharmacovigilance
The European Medicines Agency has unveiled its new ‘black triangle’ post-marketing surveillance system, and the list of drugs that will …
New head at European Medicines Agency
April 8, 2013Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA
The European Medicines Agency has appointed Agneta Brandt as the new head of Infrastructure Services. Brandt joins the Agency from …
EU orphan designations rise
February 19, 2013Research and Development, Sales and Marketing COMP, EMA, Orphan, hta
The number of orphan drug designations in the EU is set to rise to record levels this year, according to …
EMA starts contraceptive safety review
January 30, 2013Manufacturing and Production, Sales and Marketing EMA, PRAC, VTE, contraception
Europe’s health regulator is to examine the safety of newer forms of contraceptive pills following concerns over potential health risks …
Biogen and Elan file for Tysabri first line use in MS
January 18, 2013Sales and Marketing Biogen IDEC, EMA, Elan, FDA, MS, Tsyabri, gilenya
Biogen Idec and Elan have applied to the FDA and EMA to expand Tysabri’s use in patients with relapsing forms …
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