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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Xtandi (enzalutamide) capsules receive positive CHMP opinion for the treatment of men with metastatic castration-resistant prostate cancer who are chemotherapy naive
27 October 2014 - Astellas Pharma Europe Ltd. today announced that the Committee for Medicinal Products for Human Use (CHMP) ...
Posted by Michael Wonder on 05 Aug 2015
Novartis receives EU approval for Jakavi in polycythemia vera, first targeted therapy approved for patients with this rare blood cancer
Novartis announced today that the European Commission has approved Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) ...
Posted by Michael Wonder on 05 Aug 2015
Daiichi Sankyo’s once daily Lixiana (edoxaban) approved in the EU for stroke prevention in non-valvular atrial fibrillation and for the treatment and prevention of recurrent DVT and PE
Daiichi Sankyo Company, Limited today announced that the European Commission (EC) has granted marketing uthorisation for Lixiana (edoxaban), an oral, once-daily selective ...
Posted by Michael Wonder on 05 Aug 2015
Prevenar 13 receives CHMP positive opinion for prevention of vaccine-type pneumococcal pneumonia in adults
Pfizer Inc. announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive ...
Posted by Michael Wonder on 05 Aug 2015
Mundipharma receives positive European Commission decision on Targin (oxycodone/naloxone) for the treatment of restless legs syndrome
Mundipharma today announced that Targin (Targinact, Targiniq), a fixed combination of prolonged-release oxycodone/naloxone, has received a positive European Commission decision for a new ...
Posted by Michael Wonder on 05 Aug 2015
Celgene receives positive CHMP opinion to extend Revlimid (lenalidomide) for continuous use in patients with newly diagnosed multiple myeloma and ineligible for transplant
Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human ...
Posted by Michael Wonder on 05 Aug 2015
European Medicines Agency accepts Basilea's isavuconazole marketing authorization application for review
Basilea Pharmaceutica Ltd. announced today that the European Medicines Agency (EMA) has accepted its isavuconazole Marketing Authorization Application (MAA) for review. Basilea's ...
Posted by Michael Wonder on 05 Aug 2015
Europe pushes back verdict on Bristol immune system cancer drug
European regulators have postponed a decision on whether to recommend approval of a closely watched Bristol-Myers Squibb drug that helps ...
Posted by Michael Wonder on 05 Aug 2015
Vargatef (nintedanib) approved in the EU for lung cancer patients with advanced adenocarcinoma after first-line chemotherapy
Today Boehringer Ingelheim announced that the European Commission has granted EU marketing authorisation for Vargatef (nintedanib), valid for the 28 countries ...
Posted by Michael Wonder on 05 Aug 2015
European Imbruvica approval for Janssen
Janssen has received final European sign-off for its oncology treatment Imbruvica (ibrutinib) as a treatment option for adult patients with ...
Posted by Michael Wonder on 05 Aug 2015
Regulatory information – Update of EMA recommendations for 2015/2016 seasonal flu vaccine composition
The European Medicines Agency (EMA) has issued an update of the European Union (EU) recommendations for the influenza virus strains that vaccine ...
Posted by Michael Wonder on 05 Aug 2015
European Commission grants marketing authorizations for AbbVie's Viekirax (ombitasvir/paritepravir/ritonavir tablets) + Exviera (dasabuvir tablets) for the treatment of chronic hepatitis C
AbbVie announced that the European Commission has granted marketing authorizations for its all-oral, short-course, interferon-free treatment of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir ...
Posted by Michael Wonder on 05 Aug 2015
GSK files ultra-rare disease application with EMA
GlaxoSmithKline has become the first big pharma firm to file for a European marketing authorisation for a gene therapy to ...
Posted by Michael Wonder on 05 Aug 2015
Otsuka’s Jinarc the first-ever treatment approved in Europe for adults living with ADPKD, a chronic genetic kidney disease
Otsuka Pharmaceutical Co., Ltd. announced today that the European Commission has granted marketing authorisation for JINARC® (tolvaptan) for the treatment ...
Posted by Michael Wonder on 05 Aug 2015
Europe clears Simponi for non-radiographic axial spondyloarthritis
The European Commission has approved MSD’s biologic Simponi for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis. ...