Forxiga™ (dapagliflozin) now approved in European Union for treatment of type 2 diabetes
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced that the European Commission has approved Forxiga™ (dapagliflozin) tablets for the treatment of type 2 diabetes in the European Union (EU). Forxiga is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that works independently of insulin to help remove excess glucose from the body, a unique mode of action not seen in any other currently available treatments for type 2 diabetes. This is the first medicine in the new SGLT2 class to gain regulatory approval for the treatment of type 2 diabetes, a disease in which high unmet medical need exists.
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Novartis drug Votubia® approved as first medication to treat patients with non-cancerous kidney tumors associated with TSC
Novartis received approval from the European Commission (EC) for Votubia® (everolimus) tablets* for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumor size or presence of aneurysm, or presence of multiple or bilateral tumors) but who do not require immediate surgery[2]. This marks the first approval of a medical treatment in this patient population in Europe[1],[2].
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Shire enters into novel research collaboration with Italian-based Telethon's Institute of Genetics and Medicine for Rare Diseases
Shire plc (LSE: SHP, NASDAQ: SHPG), today announced a long-term, broad based, multi-indication research collaboration in rare diseases with Fondazione Telethon, a major Italian biomedical charitable foundation, for research carried out at the Telethon Institute of Genetics and Medicine (TIGEM). This alliance will facilitate research on 13 undisclosed rare disease indications and has the potential to add multiple, novel therapeutic candidates into Shire's early stage pipeline. The partnership underscores Shire's long-term commitment to bring innovative therapies to patients with rare diseases worldwide.
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Novo Nordisk files for regulatory approval of turoctocog alfa for haemophilia A
Novo Nordisk today announced the submission of the regulatory application for turoctocog alfa (NN7008) to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Turoctocog alfa is a third-generation recombinant coagulation factor VIII intended for prevention and treatment of bleeding in people with haemophilia A.
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Investigational insulin degludec shows 43% lower rates of night-time hypoglycaemia than insulin glargine
New data presented today at the Annual Meeting of the European Association for the Study of Diabetes (EASD) show that patients with type 2 diabetes starting insulin therapy had a 43% lower rate of night-time hypoglycaemia* when using insulin degludec compared with those using insulin glargine (0.27 [insulin degludec] versus 0.46 [insulin glargine] episodes per patient per year, p<0.001) with equivalent improvements in glucose control**(1).
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Novartis receives European Commission approval for once-daily Seebri® Breezhaler® as maintenance COPD treatment
Novartis announced today that the European Commission has approved Seebri® Breezhaler® (glycopyrronium bromide) 44 mcg delivered dose (equivalent to 50 mcg glycopyrronium measured dose per capsule), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). This follows the September 28 approval of once-daily Seebri® (glycopyrronium bromide) Inhalation Capsules 50 mcg in Japan.
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Roche underscores leadership in oncology with new data in HER2 positive breast cancer and skin cancer
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that data on thirteen of its investigational and approved products will be presented at the European Society for Medical Oncology (ESMO) Congress taking place in Vienna, Austria on 28 September - 2 October 2012. During the past 50 years Roche has developed and secured approval for ten cancer medicines. The data presented at ESMO 2012 reflect not only the continuing role being played by Roche's early discoveries, but also the potential of the company's newer treatments.
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