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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Accelerated assessment fast-tracks Lenvima to benefit patients with thyroid cancer
The European Medicines Agency (EMA) has recommended marketing authorisation for Lenvima (lenvatinib) for the treatment of adults with progressive, locally advanced or ...
Posted by Michael Wonder on 05 Aug 2015
Public register of parallel distribution now available
15 July 2015 - The European Medicines Agency (EMA) is launching a public register of parallel distribution notices [External link icon] , providing a ...
Posted by Michael Wonder on 05 Aug 2015
Ofev (nintedanib) approved in the EU for the treatment of IPF
Boehringer Ingelheim today announced that the European Commission has approved nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF), following an expedited ...
Posted by Michael Wonder on 05 Aug 2015
Status of the adaptive pathways pilot project
The European Medicines Agency (EMA) publishes today a report giving an update on the status ofthe adaptive pathways pilot project. ...
Posted by Michael Wonder on 05 Aug 2015
Victoza receives positive CHMP opinion for use in adults with type 2 diabetes and moderate renal impairment
The Committee for Medicinal Products for Human Use today issued a positive opinion for the use of Victoza (liraglutide) in adults with ...
Posted by Michael Wonder on 05 Aug 2015
Eisai receives European Commission approval of indication expansion for anticancer agent Halaven for advanced breast cancer only one prior chemotherapy
Eisai Co., Ltd. announced today that it has received approval from the European Commission of the indication expansion of Halaven® (generic ...
Posted by Michael Wonder on 05 Aug 2015
Early dialogue to support development of medicines for children
The European Medicines Agency (EMA) has launched an initiative that offers free-of-charge early paediatric interaction meetings with medicines developers to ...
Posted by Michael Wonder on 05 Aug 2015
New advance in COPD maintenance treatment, Spiolto Respimat, approved in first European countries
Boehringer Ingelheim today announced regulatory authority approvals for Spiolto® Respimat® (tiotropium/olodaterol) in first European countries. Spiolto Respimat is a once-daily maintenance treatment ...
Posted by Michael Wonder on 05 Aug 2015
European Commission grants marketing authorization for Cerdelga (eliglustat), Genzyme’s oral therapy for Gaucher disease type 1
Sanofi and its subsidiary Genzyme announced today that the European Commission (EC) has granted marketing authorization for Cerdelga® (eliglustat) capsules, ...
Posted by Michael Wonder on 05 Aug 2015
EMA will review Amgen/Onyx' myeloma drug
The European Medicines Agency has accepted Amgen/Onyx’ marketing authorisation application for Kyprolis (carfilzomib) as a treatment for multiple myeloma. ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb announces multiple regulatory milestones for Opdivo (nivolumab) in the U.S. and the European Union
Bristol-Myers Squibb Company today announced multiple regulatory milestones for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, in the U.S. and European Union. ...
Posted by Michael Wonder on 05 Aug 2015
Outcome report on first European collaboration between regulators and HTA organisations: improving the contribution of regulatory assessment reports to health technology assessment
The report of an initiative undertaken jointly by the European Medicines Agency (EMA) and the European network for Health Technology Assessment ...
Posted by Michael Wonder on 05 Aug 2015
EU OKs Gardasil update on long-term HPV protection
European regulators have approved an update to the product information for Sanofi Pasteur MSD’s cervical cancer jab Gardasil, to include ...
Posted by Michael Wonder on 05 Aug 2015
EU approves Roche’s Avastin for platinum-resistant recurrent ovarian cancer
Roche announced today that the European Commission (EU) approved the use of Avastin (bevacizumab) in combination with paclitaxel, topotecan, or pegylated ...
Posted by Michael Wonder on 05 Aug 2015
Oral Otezla (apremilast) approved by the European Commission for the treatment of both patients with psoriasis and psoriatic arthritis
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Commission (EC) has granted marketing authorisation ...