GlaxoSmithKline receives EU approval for a new therapeutic indication for Arixtra®
GlaxoSmithKline (GSK) confirmed that the European Commission (EC) has granted an amendment of their marketing authorisation for their anti-clotting agent (antithrombotic) Arixtra® (fondaparinux) in the European Union for a new therapeutic indication. Fondaparinux 1.5 and 2.5 mg is now indicated for thetreatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.
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Updated Pfizer Pipeline Focuses on Value, Unmet Medical Need
Pfizer Inc. (NYSE: PFE) provided an update to its development pipeline, which includes 118 programs from Phase 1 through registration. The updated pipeline continues to reflect Pfizer's ongoing investment in high-priority disease areas with considerable unmet medical need.
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Novartis obtains CHMP positive opinion for its investigational pre-pandemic influenza vaccine Aflunov®
Novartis announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Aflunov®, an investigational pre-pandemic avian influenza vaccine. The CHMP is endorsing the approval of Aflunov for active immunization against H5N1 subtype of Influenza A virus in adults 18 years of age and older.
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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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