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RSS FeedPosted by Michael Wonder on 05 Aug 2015
EMA fast-tracks enzyme replacement therapy for lysosomal acid lipase deficiency
The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Kanuma (sebelipase alfa), for the treatment of lysosomal ...
Posted by Michael Wonder on 05 Aug 2015
Vanda receives positive CHMP opinion for Hetlioz (tasimelteon) for the treatment of non-24-hour sleep-wake disorder in the European Union
Vanda Pharmaceuticals Inc. today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending ...
Posted by Michael Wonder on 05 Aug 2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2014
The CHMP has recommended five new medicines for approval at its July 2014 meeting. ...
Posted by Michael Wonder on 05 Aug 2015
European Commission approves Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE
Bristol-Myers Squibb Company and Pfizer Inc. today announced that the European Commission has approved Eliquis for the treatment of DVT and PE, and the prevention ...
Posted by Michael Wonder on 05 Aug 2015
Eisai receives European Commission approval of anti-cancer agent Lenvima for treatment of advanced thyroid cancer refractory to radio-active iodine
Eisai Co., Ltd. announced today that its U.K. subsidiary Eisai Europe Ltd. has received approval from the European Commission (EC) ...
Posted by Michael Wonder on 05 Aug 2015
GSK announces EU regulatory submission seeking extended indication for ambrisentan (Volibris) in pulmonary arterial hypertension
GSK today announced that it has filed a regulatory submission to the European Medicines Agency (EMA) for a variation to ...
Posted by Michael Wonder on 05 Aug 2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 December 2014
Seven new medicines have been recommended for marketing authorisation at the December 2014 meeting of the Committee for Medicinal Products for Human Use ...
Posted by Michael Wonder on 05 Aug 2015
Facilitating global development of biosimilars
The European Medicines Agency (EMA) has published its revised overarching guidelineon biosimilars. The main change brought by this new guidance is ...
Posted by Michael Wonder on 05 Aug 2015
Shire receives CHMP positive opinion in Europe for Intiniv (guanfacine hydrochloride extended release) as a non-stimulant ADHD treatment for children and adolescents
Shire plc. today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the ...
Posted by Michael Wonder on 05 Aug 2015
European Commission grants Lilly and Boehringer Ingelheim's insulin glargine product marketing authorisation in Europe
The European Commission (EC) granted marketing authorisation for Eli Lilly and Company and Boehringer Ingelheim’s insulin glargine product, indicated to ...
Posted by Michael Wonder on 05 Aug 2015
Europe to boost cooperation with international partners on generics
The European Union’s decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International ...
Posted by Michael Wonder on 05 Aug 2015
WHO adds important new (but expensive) medicines on the EML
The World Health Organization (WHO) today published the new edition of its Model List of Essential Medicines) which includes ground-breaking ...
Posted by Michael Wonder on 05 Aug 2015
Allergan Announces Ozurdex (dexamethasone 700 mcg intravitreal implant in applicator) now approved in the European Union for the treatment of diabetic macular edema
Allergan, Inc. announced today that the European Commission has extended the Marketing Authorization for Ozurdex (dexamethasone 700 mcg intravitreal implant in applicator) to treat ...
Posted by Michael Wonder on 05 Aug 2015
European Commission approves Esmya 5 mg for intermittent treatment in the long term management of uterine fibroids (myomas)
Gedeon Richter Plc. announces that the European Commission (EC) has granted approval for the intermittent use of Esmya 5 mg in the long term management of uterine fibroids. This ...
Posted by Michael Wonder on 05 Aug 2015
Samsung Bioepis submits marketing authorization application for SB2, a Remicade (infliximab) biosimilar candidate, to the European Medicines Agency
Samsung Bioepis Co., Ltd., today announced that the Marketing Authorization Application (MAA) for SB2, its Remicade (Infliximab) biosimilar candidate, has been submitted to ...