GSK regulatory update on Avandia following EMA and FDA reviews
GlaxoSmithKline (GSK) confirms that following a review of Avandia® (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), each agency has announced their individual regulatory decisions and the resulting actions. In the European Union*, the EMA has suspended the marketing authorisation for all rosiglitazone-containing medicines (Avandia, Avandamet® and Avaglim®).
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BRILIQUE (ticagrelor) receives positive opinion from European CHMP for the treatment of Acute Coronary Syndromes
AstraZeneca announced today that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the marketing authorisation application for BRILIQUE™ (ticagrelor) for the prevention of atherothrombotic events in adult patients with Acute Coronary Syndromes (ACS). The positive opinion by the Committee is now referred for a final decision by the European Commission. The European Commission, which makes the decision whether to approve a new drug candidate for use in the European Union, typically renders its decision within a few months of the CHMP issuing its opinion.
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Merck Inaugurates New Material Research Center in Darmstadt
With the opening of a new research center, the pharmaceutical and chemical company Merck is underscoring the importance of chemical research at its corporate headquarters in Darmstadt. German Federal Chancellor Dr. Angela Merkel and Dr. Karl-Ludwig Kley, Chairman of the Executive Board of Merck KGaA, officially opened the Material Research Center (MRC) in the presence of the Prime Minister of the Federal State of Hesse Volker Bouffier as well as about 300 other guests.
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Bayer Diabetes Care simplifies life with diabetes
Patients with diabetes need precise measurements of their blood glucose values for managing their condition successfully. Bayer HealthCare helps to simplify life with the metabolic disorder by offering technically sophisticated devices, which are easy to operate and capable of delivering reliable results quickly. But for understanding social and psychological barriers that may prevent patients from regular self-testing, diabetes nurses are in a key position.
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Boehringer Ingelheim Initiates Phase III Clinical Trial with Novel Oral Agent in Advanced Breast Cancer
Boehringer Ingelheim announced the initiation of a phase III clinical trial to investigate one of its most advanced oncology pipeline compounds, afatinib, for the treatment of patients with advanced (metastatic) breast cancer. Afatinib is an oral compound (taken as a tablet), which is a next generation, targeted therapy, that irreversibly inhibits both, the epidermal growth factor receptor (EGFR/HER1) and the human epidermal receptor HER2, which are involved in tumour growth and spread(1).
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"The Merck Way" Presented in a New Image Brochure and Film
What makes Merck what it is, what distinguishes it from other companies? Answers to these questions can now be found in an image brochure entitled "The Merck Way". Dr. Walter Huber, Head of Corporate Communications, explained: "The 28-page illustrated brochure presents the company's culture, values, history, strategy and objectives as well as the business sectors and the ownership structure. Customers, applicants, investors, journalists and neighbors will find out who and what Merck is."
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European Union Approves MSD's New Single Dose 'Ivemend'®
Merck (known as MSD outside the United States and Canada) today announced that the European Union has granted marketing approval for a new, single dose regimen of 'Ivemend'® (fosaprepitant) 150 mg. Fosaprepitant is used in adults in combination with other antiemetic medicines for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin (HEC)-based chemotherapy and moderately emetogenic chemotherapy (MEC).
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