European Commission Approves Brilique™ (Ticagrelor Tablets)
AstraZeneca announced that the European Commission has granted marketing authorisation to BRILIQUE™ (ticagrelor tablets) for the prevention of atherothrombotic events in adult patients with Acute Coronary Syndromes (ACS). This decision follows the positive opinion from the Committee for Medicinal Products for Human Use on 23rd September and is applicable to the 27 Member States and the 3 European Economic Area countries of the European Union.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced positive data from a Phase III study of Rituxan/MabThera (rituximab) in patients with advanced follicular lymphoma who did not have symptoms of disease (asymptomatic disease). Based on results of previous studies(1) that showed no benefit of immediate chemotherapy after diagnosis, asymptomatic patients are managed by a "watchful waiting" approach and treatment for these patients usually does not begin until specific symptoms occur or their disease worsens.
With more than 170 presentations focused on its marketed and pipeline compounds at key oncology medical congresses in December, Novartis continues to demonstrate progress of its innovative research and development efforts, collaboration with the scientific community and commitment to patients with cancer and rare diseases[1],[2].
Pfizer Inc. (NYSE: PFE) and Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX, TASE: PLX) announced the submission of a Marketing Authorization Application to the European Medicines Agency for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD)for the treatment of Gaucher disease. Taliglucerase alfa was granted Orphan Designation by the European Commission for the treatment of Gaucher disease on March 23, 2010.
GlaxoSmithKline (GSK) and JSC Binnopharm (Binnopharm) announced an alliance to enable the local secondary manufacture of a number of GSK vaccines in Russia. The agreement was signed in Moscow during the session of the Russian-British Intergovernmental Steering Committee (ISC) for Trade and Investment.
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) reported that the companies have discontinued the Phase 3 APPRAISE-2 clinical trial in patients with recent Acute Coronary Syndrome (ACS) treated with apixaban or placebo in addition to mono or dual antiplatelet therapy. The study was stopped early based on the recommendation of an independent Data Monitoring Committee (DMC).