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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Fast track routes for medicines that address unmet medical needs
The European Medicines Agency (EMA) has revised its guidelines on the implementation of accelerated assessment and conditional marketing authorisation, two key tools in the European ...
Posted by Michael Wonder on 05 Aug 2015
New treatment option for patients with advanced lung cancer
The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Nivolumab BMS (nivolumab). Nivolumab BMS can be used to treat ...
Posted by Michael Wonder on 05 Aug 2015
Promoting high quality scientific research in paediatric medicines
Enpr-EMA will hold its 7th annual workshop on 28 May 2015 at the EMA. The aim of the annual workshop is ...
Posted by Michael Wonder on 05 Aug 2015
Relistor approved in EU to treat all opioid-induced constipation
Valeant Pharmaceuticals International Inc. and Progenics Pharmaceuticals Inc. announced that the European Commission has approved Relistor (methylnaltrexone bromide) subcutaneous injection for the ...
Posted by Michael Wonder on 05 Aug 2015
Merck announces European Medicines Agency acceptance of marketing authorization application for grazoprevir/elbasvir, an investigational therapy for treatment of chronic hepatitis C infection
Merck, known as MSD outside the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for ...
Posted by Michael Wonder on 05 Aug 2015
Baxter BioScience and Merrimack Pharmaceuticals announce filing for European approval of MM-398, an investigational treatment for post-gemcitabine metastatic pancreatic cancer
Baxter International Inc. and Merrimack Pharmaceuticals, Inc. jointly announced that Baxter has submitted a marketing authorization application (MAA) to the European Medicines ...
Posted by Michael Wonder on 05 Aug 2015
European Commission grants marketing authorization for Gilead’s Zydelig (idelalisib) for the treatment of chronic lymphocytic leukemia and follicular lymphoma
Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Zydelig (idelalisib), 150 mg tablets, a first-in-class oral treatment for ...
Posted by Michael Wonder on 05 Aug 2015
Europe approves novel Australian drug developed for rare sun disease
The first new pharmaceutical drug invented and developed for an untreated disorder by any Australian company has received regulatory approval ...
Posted by Michael Wonder on 05 Aug 2015
Amgen receives positive CHMP opinion for use of Repatha (evolocumab) for the treatment of high cholesterol
Amgen today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency(EMA) has adopted a positive opinion for ...
Posted by Michael Wonder on 05 Aug 2015
New indication for Teijin Pharma’s febuxostat in Europe
Teijin Pharma Limited, the core company of the Teijin Group’s medical and pharmaceutical business, announced today, the Menarini Group, a sublicensee ...
Posted by Michael Wonder on 05 Aug 2015
GSK announces EU regulatory submission for malaria vaccine candidate RTS,S
GSK announced today that it has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine ...
Posted by Michael Wonder on 05 Aug 2015
European Commission approves Amgen's new cholesterol-lowering medication Repatha (evolocumab), the first PCSK9 inhibitor to be approved in the world, for treatment of high cholesterol
Amgen today announced that the European Commission (EC) has granted marketing authorization for Repatha (evolocumab), the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor ...
Posted by Michael Wonder on 05 Aug 2015
European Medicines Agency accepts Samsung Bioepis’ Enbrel biosimilar candidate, SB4, for regulatory review
Samsung Bioepis Co., Ltd., today announced that the Marketing Authorization Application (MAA) for its Enbrel (etanercept) biosimilar candidate, SB4 has ...
Posted by Michael Wonder on 05 Aug 2015
Sanofi and Regeneron announce CHMP recommends European approval of Praluent (alirocumab) for the treatment of hypercholesterolaemia
Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the European Medicine Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has adopted ...
Posted by Michael Wonder on 05 Aug 2015
European Medicines Agency validates two parallel type II variation applications to extend the Opdivo (nivolumab) indication in Europe
Bristol-Myers Squibb Company today announced that the European Medicines Agency (EMA) has validated two of the company’s type II variation applications, ...