GlaxoSmithKline and Human Genome Sciences receive positive opinion in Europe from the CHMP for Benlysta® (belimumab)
GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending marketing authorisation for Benlysta® (belimumab) as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy. 
The European Commission has approved ELIQUIS® in the 27 countries of the European Union (EU) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. This decision marks the first approval for ELIQUIS®, a new oral direct Factor Xa inhibitor being developed by the alliance of Bristol-Myers Squibb Company and Pfizer Inc. 
Takeda Pharmaceutical Company Limited ("Takeda", TSE: 4502) and Nycomed A/S ("Nycomed") jointly announced today that Takeda has reached an agreement with the shareholders of Nycomed in which Takeda will acquire the Zurich-headquartered company for 9.6 billion Euro on a cash-free, debt-free basis. The boards of directors of each company unanimously approved the transaction which is expected to be completed within 90 to 120 days, making it a wholly owned subsidiary of Takeda, subject to antitrust clearance. The purchase would exclude Nycomed's U.S. dermatology business. 
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the company submitted a New Drug Application for vemurafenib (RG7204, PLX4032) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application to the European Medicines Agency (EMA) for approval for people with BRAF V600 mutation-positive metastatic melanoma. Roche also submitted an application for the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic. Vemurafenib, a "BRAF-inhibitor", is designed to selectively target and inhibit a mutated form of the BRAF protein found in about half of all cases of melanoma, the deadliest and most aggressive form of skin cancer. 
AstraZeneca announced new health economics data from a substudy of the PLATO trial showed that treating a broad spectrum of acute coronary syndrome (ACS) patients with BRILIQUE (ticagrelor) was more cost-effective than treatment with generic clopidogrel. The study demonstrated that ticagrelor provided a cost-effective gain in quality-adjusted life year (QALY) compared to generic clopidogrel based on the approved ticagrelor label in the European Union (EU). Specifically, ACS patients treated with ticagrelor and aspirin, compared with generic clopidogrel plus aspirin for one year on average were projected to gain an additional 0.13 QALYs at a cost range of €2,350 ($3,110)–€5,700 ($7,550) per QALY.