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RSS FeedPosted by Michael Wonder on 29 Feb 2020
Highlights from the 24-27 February 2020 CHMP meeting
28 February 2020 - Two new medicines recommended for approval ...
Posted by Michael Wonder on 25 Feb 2020
EMA publishes agenda for 24-27 February CHMP meeting
25 February 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 24 Feb 2020
Novartis announces FDA and EMA filing acceptance of ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis
24 February 2020 - Filings are supported by Phase III ASCLEPIOS I and II studies, where ofatumumab showed highly significant and ...
Posted by Michael Wonder on 19 Feb 2020
European Commission approves Vyndaqel, the first treatment in the EU for transthyretin amyloid cardiomyopathy (ATTR-CM)
19 February 2020 - Vyndaqel is the only EC-approved medicine proven to reduce mortality and frequency of cardiovascular-related hospitalisations in adults ...
Posted by Michael Wonder on 18 Feb 2020
Novartis receives EC approval for Beovu, a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide
17 February 2020 - Beovu (brolucizumab) is the only anti-VEGF treatment approved in Europe for wet AMD that offers the option ...
Posted by Michael Wonder on 11 Feb 2020
Fennec Pharmaceuticals completes rolling submission of new drug application to U.S. FDA for Pedmark and also submits marketing authorisation application to EMA
11 February 2020 - Pedmark is being developed for prevention of cisplatin-induced hearing loss in children. ...
Posted by Michael Wonder on 05 Feb 2020
EMA to support development of vaccines and treatments for novel coronavirus
4 February 2020 - To contribute to the global response to the outbreak of the novel coronavirus (2019-nCoV) infections, EMA ...
Posted by Michael Wonder on 04 Feb 2020
EU flags are up in EMA’s new building in Amsterdam
3 February 2020 - EMA’s staff gathered today to raise the EU flags in the lobby of its new and ...
Posted by Michael Wonder on 04 Feb 2020
Rybelsus (oral semaglutide) recommended for approval for the treatment of adults with type 2 diabetes by the European regulatory authorities
31 January 2020 - Novo Nordisk today announced that the CHMP under the EMA has adopted a positive opinion, recommending ...
Posted by Michael Wonder on 03 Feb 2020
GSK announces EMA accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma
3 February 2020 - Belantamab mafodotin accepted for accelerated assessment by the EMA’s CHMP. ...
Posted by Michael Wonder on 03 Feb 2020
Pfizer receives positive CHMP opinion for oncology biosimilar, Ruxience (rituximab)
31 January 2020 - Pfizer today announced that the CHMP of the EMA has adopted a positive opinion, recommending marketing ...
Posted by Michael Wonder on 03 Feb 2020
Esperion announces positive CHMP opinion for the marketing authorisation application for bempedoic acid for the treatment of hypercholesterolaemia and mixed dyslipidaemia
31 January 2020 - Positive CHMP opinion is based on the completed pivotal Phase 3 LDL-cholesterol lowering program. ...
Posted by Michael Wonder on 03 Feb 2020
Emergent BioSolutions receives positive CHMP opinion for Vaxchora; anticipates near-term approval by European Medicines Agency
31 January 2020 - Emergent BioSolutions today announced that the CHMP of the EMA adopted a positive opinion for the approval ...
Posted by Michael Wonder on 03 Feb 2020
Bayer receives positive CHMP opinion for darolutamide as a new treatment for men with non-metastatic castration-resistant prostate cancer
31 January 2020 - CHMP opinion is based on Phase III ARAMIS trial data evaluating the efficacy and safety of darolutamide ...
Posted by Michael Wonder on 03 Feb 2020
Alnylam receives positive CHMP opinion for Givlaari (givosiran) for the treatment of acute hepatic porphyria in adults and adolescents
31 January 2020 - Positive opinion is based on data from the pivotal ENVISION Phase 3 study. ...