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RSS FeedPosted 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 ...
Posted by Michael Wonder on 05 Aug 2015
Abraxane approved by European Commission for first-line treatment of patients with non-small cell lung cancer
Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation, today announced that the European Commission (EC) has approved Abraxane (paclitaxel ...
Posted by Michael Wonder on 05 Aug 2015
Update on publication of clinical data
The European Medicines Agency (EMA) has published today the video recording of its webinar held on 24 June to provide ...
Posted by Michael Wonder on 05 Aug 2015
Amicus Therapeutics submits marketing authorisation application (MAA) for full approval of Fabry monotherapy Galafold (migalastat) in European Union
Amicus Therapeutics, a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, has submitted a marketing authorisation ...