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RSS FeedPosted 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 ...
Posted by Michael Wonder on 05 Aug 2015
EMA to further clarify safety profile of human papillomavirus (HPV) vaccines
The European Medicines Agency (EMA) has started a review of HPV vaccines to further clarify aspects of their safety profile. ...
Posted by Michael Wonder on 05 Aug 2015
Roche's Gazyvaro approved in Europe for patients with the most common type of leukaemia
Roche today announced that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people ...
Posted by Michael Wonder on 05 Aug 2015
First medicine recommended for approval for hidradenitis suppurativa
The European Medicines Agency (EMA) has recommended extending the use of Humira (adalimumab) to include treatment of adults with active ...
Posted by Michael Wonder on 05 Aug 2015
Novartis combination therapy Tafinlar and Mekinist achieves important EU and US regulatory milestones
Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has ...
Posted by Michael Wonder on 05 Aug 2015
EMA accepts Eisai's request for accelerated assessment of anticancer agent lenvatinib
Eisai Co., Ltd. announced today that its U.K. subsidiary Eisai Europe Ltd. has been granted an accelerated review by the European ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer receives European approval for new indication for Prevenar 13 for prevention of vaccine-type pneumococcal pneumonia in adults
Pfizer Inc. announced today that the European Commission approved an expanded indication for the use of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine ...
Posted by Michael Wonder on 05 Aug 2015
Basilea announces that CHMP recommends approval of isavuconazole (Cresemba) as a treatment for invasive aspergillosis and mucormycosis in the European Union
Basilea Pharmaceutica Ltd. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted ...
Posted by Michael Wonder on 05 Aug 2015
European Medicines Agency validates marketing authorization application for Natpar (parathyroid hormone (rDNA)) in hypoparathyroidism
NPS Pharmaceuticals, Inc, a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, ...
Posted by Michael Wonder on 05 Aug 2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 October 2014
Six new medicines have been recommended for approval at the October meeting of the Committee for Medicinal Products for Human Use (CHMP), ...
Posted by Michael Wonder on 05 Aug 2015
Merck’s investigational anti-PD-1 antibody, pembrolizumab, under regulatory review in Europe for the treatment of advanced melanoma
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
Progress in science, medicines, health
The annual report published by the European Medicines Agency (EMA) today focuses on the Agency’s key priorities, including the evaluation of medicines ...
Posted by Michael Wonder on 05 Aug 2015
European Commission grants marketing authorization for Gilead’s Harvoni (ledipasvir/sofosbuvir), the first single tablet regimen to treat the majority of chronic hepatitis C patients with genotype 1 and 4
Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single ...