European Medicines Agency
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Furiex Confirms Takeda’s Announcement on the Acceptance of the European Medicines Agency Submission of Alogliptin for the Treatment of Type 2 Diabetes
Business Wire
N.C.--(BUSINESS WIRE)--Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda Global Research & Development Centre (Europe) Ltd. received confirmation on the acceptance of the submission of a Marketing Authorization Application, or MAA,... Full Article at Business Wire
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As with other components, the global manufacturing and regulatory communities need to be vigilant.' To gain entry to US or EU markets, foreign manufacturers' facilities must currently first be inspected and approved by the FDA or the European Medicines... Full Article at Chemistry World
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Jakavi
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Read the full story here. New Once-Daily HIV Pill Available In UK Eviplera, a new once-daily pill for the treatment of HIV has been made available in 27 countries of the European Union following approval by the European Medicines Agency. The new drug,... Full Article at The Huffington Post
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Clinuvel’s lead compound, SCENESSE® (afamelanotide), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe. In February 2012 SCENESSE® was filed for review by the European... Full Article at Check Orphan
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The third case involves Orphacol. Orphacol is a medicine used for the treatment of two extremely rare and serious child liver diseases, and is an alternative to liver transplantation. The medicine was approved twice unanimously by the European... Full Article at EurActive.com
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However, these new data bring us considerably closer to the time when cancer prevention can be integrated into the clinical guidelines for prophylactic treatment following regulatory review by the FDA and the European Medicines Agency
SOURCE: Oh-yay.com -
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Navidea has been advised by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) that the Committee has adopted the advice of the Scientific Advice Working Party (SAWP) regarding the Lymphoseek development program... Full Article at Seeking Alpha
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Amgen's BiTE Antibody Blinatumomab Achieved High Rate of Complete Response in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Check OrphanBlinatumomab is the first of the BiTE antibodies and Amgen has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of ALL, chronic lymphocytic leukemia (CLL), hairy cell leukemia, prolymphocytic leukemia and... Full Article at Check Orphan
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The new version includes an integrated submission gateway module that makes the transmission of information to EMA a seamless process. The new version also provides support for the latest EMA controlled vocabularies. Additionally, the time required to... Full Article at MarketWire
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