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Last updated on April 23, 2014 at 20:10 EDT

Latest European Medicines Agency Stories

2014-04-15 23:02:22

The Firm is evaluating testosterone treatment lawsuits on behalf of men who suffered heart attacks, strokes, deep vein thrombosis, pulmonary embolism, and other cardiovascular problems allegedly due to the use of prescription low testosterone therapies. New York, New York (PRWEB) April 15, 2014 As testosterone lawsuits (http://www.testosteronelawsuitcenter.com/) involving AndroGel and other low testosterone therapies continue to move forward in U.S. courts, Bernstein Liebhard LLP notes...

2014-04-15 23:01:01

The European Medicines Agency (EMA) is investigating the potential cardiovascular risks of testosterone therapies, according to a report in MedPage Today. In January, the U.S. Food and Drug Administration (FDA) also began investigating these products; both agencies launched their reviews due to two studies linking testosterone drugs to a higher risk of heart attack and other cardiovascular issues. New York, New York (PRWEB) April 15, 2014 Parker Waichman LLP, a national law firm dedicated...

2014-04-10 23:00:56

Symposium to Highlight How Legislation in Europe and U.S. Can Help Bring Medicines to Market Washington (PRWEB) April 10, 2014 “Regulatory Challenges for Orphan Medicines,” a symposium that features presentations by a number of industry experts, will take place during the DIA 2014 50th Annual Meeting at the San Diego Convention Center from June 15 to 19. The symposium, held June 18 at 3:30 p.m., will focus on the regulatory environment and trends for orphan medicinal products around...

2014-04-07 04:21:16

MADISON, Wis., April 7, 2014 /PRNewswire/ -- The European Medicines Agency (EMA) has granted Minor Use Minor Species (MUMS) designation for Nexcyon's adrenocorticotropin (ACTH), a synthetic peptide for the diagnosis of hypoadrenocorticism in dogs. Hypoadrenocorticism, also known as Addison's Disease, can be difficult to diagnose without the aid of an ACTH injection. Nexcyon has developed a proprietary form of synthetic ACTH specifically formulated for use in dogs. Presently, when...

2014-04-01 16:25:15

- Timely collaborations underscore ViiV Healthcare's commitment to increase access to life-saving HIV medicines for children and adults in the developing world LONDON, April 1, 2014 /PRNewswire/ -- ViiV Healthcare today announced new collaborations with the goal of increasing access to its HIV medicine, dolutegravir (marketed under the name Tivicay®), just two months after its approval by the European Medicines Agency (EMA) and eight months after approval by the US Food and Drug...

2014-03-21 08:24:55

Positive opinion is based on data from one of the largest clinical registration programs in its class, involving more than 13,000 adults with type 2 diabetes RIDGEFIELD, Conn. and INDIANAPOLIS, March 21, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending approval of empagliflozin, an...

2014-03-18 23:01:55

The 26th annual EuroMeeting, coming to Austria’s capital from 25-27 March, will feature more than 100 sessions in 16 parallel themes and the chance to hear from 300+ expert speakers, including representatives from the European Medicines Agency (EMA), the European Commission and regulatory agencies from around the world. BASEL, SWITZERLAND (PRWEB) March 18, 2014 In less than one week’s time more than 2,500 professionals from around the world will gather in Vienna at DIA’s largest...

2014-03-11 23:33:07

The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the participation of high-level speakers from the U.S. Food and Drug Administration (FDA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA), as well as leaders from industry and academia at the 2014 CDISC Europe Interchange from 7-11 April in Paris, France. Austin, Texas (PRWEB) March 11, 2014 The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the participation of...

2014-02-25 23:01:34

More than 30 program offerings will delve into the safety of medicines and clinical practices. Horsham, PA (PRWEB) February 25, 2014 The Food and Drug Administration (FDA) and European Medicines Agency (EMA) will discuss common objectives and challenges in pharmacovigilance and clinical safety at DIA’s Annual Meeting from June 15 to 19 in San Diego. The June 17 session, “FDA-EMA Collaboration in Pharmacovigilance: Common Objectives and Common Challenges,” will focus on joint efforts...

2014-02-12 23:23:59

The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has purchased a global license for the ADDPLAN platform. The license includes ADDPLAN DF, the first commercial tool for using the MCP-Mod methodology recently qualified this year by the European Medicines Agency as an efficient statistical methodology for Phase II dose finding studies. Reston, Virginia (PRWEB) February 12, 2014 Aptiv Solutions, a global biopharmaceutical and medical device development services company leading the...