Blog
RSS FeedPosted by Michael Wonder on 05 Aug 2015
Scientific advice leads to stronger applications from industry
Adherence to EMA scientific advice on trial design results in higher success rates, shorter overall assessment time and fewer major objections during ...
Posted by Michael Wonder on 05 Aug 2015
European Medicines Agency selects first two medicines to be included in its adaptive licensing pilot project
The European Medicines Agency has received 20 applications so far as part of its adaptive licensing pilot project. Following an ...
Posted by Michael Wonder on 05 Aug 2015
Major European research project on monitoring and evaluation of medicines concludes
The European Medicines Agency (EMA) will host and broadcast a symposium on 19 and 20 February to mark the conclusion of the ...
Posted by Michael Wonder on 05 Aug 2015
Taiho submits TAS-102 marketing authorization application to the European Medicines Agency for the treatment of refractory metastatic colorectal cancer
Taiho Pharmaceutical Co., Ltd. today announced that Taiho Pharma Europe Ltd., a subsidiary of Taiho Pharmaceutical, has submitted on February 27, ...
Posted by Michael Wonder on 05 Aug 2015
Regulatory information - Further guidance on adaptive licensing pilot project available
Based on the initial experience gained from its adaptive licensing pilot project, the European Medicines Agency has released a document to address ...
Posted by Michael Wonder on 05 Aug 2015
Amicus Therapeutics' Fabry monotherapy granted accelerated assessment by European regulators
Amicus Therapeutics, a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced that the Committee ...
Posted by Michael Wonder on 05 Aug 2015
Saxenda approved in Europe for the treatment of obesity
Novo Nordisk today announced that the European Commission has granted marketing authorisation for Saxenda (liraglutide 3 mg) for the treatment of ...
Posted by Michael Wonder on 05 Aug 2015
Stimulating the development of medicines for children
The European Medicines Agency’s Paediatric Committee (PDCO) has revised the current list of class waivers for medicines that are not required to submit a paediatric ...
Posted by Michael Wonder on 05 Aug 2015
Sanofi, Regeneron: Praluent (alirocumab) marketing authorization application accepted for review by EMA
Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization ...
Posted by Michael Wonder on 05 Aug 2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2015
At its July meeting, the Committee for Medicinal Products for Human Use (CHMP) gave a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B ...
Posted by Michael Wonder on 05 Aug 2015
Amgen submits marketing authorization application for novel investigational LDL cholesterol-lowering medication evolocumab to the European Medicines Agency
Amgen today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) via the centralized procedure for evolocumab ...
Posted by Michael Wonder on 05 Aug 2015
Rare Disease Day 2015
The European Medicines Agency (EMA) supports Rare Disease Day 2015 taking place on Saturday 28 February. ...
Posted by Michael Wonder on 05 Aug 2015
EMA Management Board: highlights of October 2014 meeting
The European Medicines Agency’s (EMA) Management Board unanimously adopted a new policy on the publication of clinical reports that underpin the decision-making ...
Posted by Michael Wonder on 05 Aug 2015
Orexigen's Mysimba (naltrexone HCl / bupropion HCl prolonged release) receives positive CHMP opinion recommending approval for weight management in the European Union
Orexigen Therapeutics announced today that the Committee for Medicinal Products For Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion ...
Posted by Michael Wonder on 05 Aug 2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2015
Five new medicines have been recommended for approval at the March 2015 meeting of the Committee for Medicinal Products for Human ...