KOMBOGLYZE™ receives marketing authorisation in the European Union
AstraZeneca and Bristol-Myers Squibb Company announced that the European Commission has granted marketing authorisation for KOMBOGLYZE™ (saxagliptin and metformin HCl immediate-release fixed dose combination) that will cover the 27 Member States of the European Union. The indication for KOMBOGLYZE is as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with Type 2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.
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Novartis gains European Commission approval for Rasitrio®
Novartis announced that Rasitrio®, the first triple combination of aliskiren, amlodipine and hydrochlorothiazide (HCT) in a single pill, has received approval from the European Commission (EC) for the treatment of high blood pressure. "For the first time, high blood pressure patients in Europe with complex needs will have access to a single pill combining the unique properties of Rasilez with two well-established and effective high blood pressure treatments," said David Epstein, Division Head of Novartis Pharmaceuticals.
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AstraZeneca announced that the Marketing Authorisation Application for CAPRELSA (vandetanib) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. The proposed indication also states that for patients in whom Rearranged during Transfection (RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions.
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GlaxoSmithKline (GSK) welcomes the European Commission's commitment to promote collaborative research efforts to develop new antibiotics against the growing threat from resistant bacteria. Within its Action plan against the rising threats from Antimicrobial Resistance, the Commission recognises the challenges faced by the pharmaceutical industry in discovering and developing new antibiotics and commits to help fund a collaborative research and development programme involving industry and public partners.
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Pfizer's Vyndaqel® (tafamidis) First Therapy Approved in the European Union
Pfizer announced today that the European Commission has approved Vyndaqel® (tafamidis) for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) in adult patients with stage 1 symptomatic polyneuropathy. TTR-FAP is a rare, progressive and fatal neurodegenerative disease that affects approximately 8,000 patients worldwide.(1,2,3)
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Data published in The Lancet Oncology support high efficacy previously demonstrated by Cervarix®
An analysis published today in TheLancet Oncology reinforces previous findings showing that GlaxoSmithKline's Cervarix®, provided protection against advanced precancerous lesions (CIN3+), above that expected from a vaccine that protects against human papillomavirus (HPV) types 16 and 18. CIN3+ is the immediate step before invasive cervical cancer and data showing protection against this type of lesion are considered the most stringent evidence of potential cervical cancer prevention.(1)
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Sanofi net sales up 10.1% and Business net income up 4.1% at CER
Sanofi's net sales in the third quarter of 2011 were €8,753 million, an increase of 5.0% on a reported basis. Exchange rate movements had a negative effect of 5.1 percentage points, mainly due to a less favorable euro/U.S. dollar parity. Various currencies from Emerging Markets (notably the Venezuelan Bolivar and Turkish Lira) also had an unfavorable impact. At constant exchange rates, and including changes in structure (primarily the consolidation of Genzyme from April 1st), net sales increased by 10.1%.
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