Xigduo™ (dapagliflozin and metformin hydrochloride) receives positive CHMP opinion for the treatment of type 2 diabetes
AstraZeneca and Bristol-Myers Squibb today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Xigduo™ (dapagliflozin and metformin hydrochloride) for adults aged 18 and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their current metformin-based treatment regimen or who are currently being treated with the combination of dapgliflozin and metformin as separate tablets. 
Bayer HealthCare announced that the European Commission (EC) has granted marketing authorisation for Xofigo® 1000 kBq/ml, solution for injection (radium Ra 223 dichloride) for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. This decision follows a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) in September of this year. The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. 
Novartis announced a definitive agreement to divest its blood transfusion diagnostics unit to Grifols for USD 1.675 billion. This transaction, requiring customary regulatory approvals, is expected to be completed in the first half of 2014. "The sale of the Novartis blood transfusion diagnostics unit enables us to focus more sharply on our strategic businesses while providing Grifols with a platform for global expansion," said Joseph Jimenez CEO of Novartis. "I am especially pleased that the agreement with Grifols provides our associates with an opportunity to join a company that will focus on growing this business aggressively." 
Scottish patients will benefit from the latest medical advances under a new Pfizer and NHS Scotland partnership for clinical trials. Further boosting Scotland's reputation as a global centre of excellence for research, four health boards (NHS Grampian, Greater Glasgow &Clyde, Lothian and Tayside) will become a Pfizer INSPIRE site. This will see them become one of the company's preferred international sites for future research studies. Under the programme, Pfizer and the health boards will share expert knowledge and experience of medicines research to help bring innovative new medicines to patients in Scotland, the UK and around the world. 
Group sales rose 6% to 34.9 billion Swiss francs in the first nine months of the year due to strong demand for Roche's HER2 breast-cancer treatments, as well as higher sales of Avastin and clinical laboratory products from the Diagnostics Division. For the fifth consecutive year Roche was ranked as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry in the Dow Jones Sustainability Index (DJSI), highlighting the Group's commitment to responsible business practices and the creation of long-term value. 
Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion on its recombinant factor VIII product turoctocog alfa, with the intended brand name NovoEight®. The Committee recommended marketing authorisation for NovoEight® for the treatment and prophylaxis of bleeding in patients with haemophilia A.