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Latest European Medicines Agency Stories

2014-07-10 12:30:41

WINDSOR, England, July 10, 2014 /PRNewswire/ -- Sigma Tau Pharma Ltd. (hereinafter referred to as Sigma-Tau Rare Disease), today announced the submission of an application to the European Medicines Agency (EMA) for use of its pegylatedL-asparaginase, Oncaspar(R) (pegaspargase) for the treatment of Acute Lymphoblastic Leukaemia (ALL) as part of a multi-agent chemotherapeutic regimen. (Logo: http://photos.prnewswire.com/prnh/20140710/696813 ) The submission is...

2014-06-25 08:31:00

STOCKHOLM and CHESTERBROOK, Pa., June 25, 2014 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi) and Auxilium Pharmaceuticals, Inc. today announced that Sobi has filed for an extension of the label for Xiapex® (collagenase clostridium histolyticum) with the European Medicines Agency (EMA) to include the indication of Peyronie's disease. The filing is based on positive safety and efficacy outcome data from two double-blind placebo-controlled studies, IMPRESS I and II (The...

2014-06-23 23:12:15

Drugmakers for the first time must now report adverse drug reactions (ADRs) caused by their products in all uses, including off-label use. In a July 1, 2014 webinar, FDAnews and EU law expert Elisabethann Wright, a partner in Hogan Lovells’ Brussels, Belgium office, will provide answers and in-depth information. Falls Church, VA (PRWEB) June 23, 2014 Complying With the New EMA Pharmacovigilance Rules Filling the Obligations Without Committing Off-Label Violations **FDAnews Webinar**...

2014-06-23 04:20:30

PARIS, June 23, 2014 /PRNewswire/ -- Pharnext SAS today announced that the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designation to PXT-3003 for the treatment of Charcot-Marie-Tooth disease type 1A (CMT 1A). Highlights

2014-06-04 23:05:47

Sessions to provide international perspectives and reveal new collaborative approaches. Washington (PRWEB) June 04, 2014 The world’s foremost drug industry regulators will address urgent topics surrounding regulatory guidance, such as the challenges and future of the Food and Drug Administration (FDA) and its international counterparts, at the DIA 2014 50th Annual Meeting to be held at the San Diego Convention Center from June 15 to 19. “We are honored and excited to have the...

2014-06-03 23:00:56

Chris Geiger, author of “The Cancer Survivors Club”, and Dr. Fergus Sweeney, Head Inspections and Human Medicines Pharmacovigilance Division at the European Medicines Agency, will keynote the PhUSE Annual Conference in London, UK in October 2014. (PRWEB) June 04, 2014 PhUSE is proud to announce Chris Geiger and Dr. Fergus Sweeney as keynote speakers for their 10th annual conference which is themed “Data Transparency”. Following keynotes from Dr. Ben Goldacre in 2013, Charles...

2014-05-23 08:23:53

- The first treatment for the underlying cause of Duchenne muscular dystrophy - SOUTH PLAINFIELD, N.J., May 23, 2014 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that following its request for re-examination, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the company's application for a conditional marketing authorization of Translarna(TM) (ataluren) for the treatment...

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...


Word of the Day
attercop
  • A spider.
  • Figuratively, a peevish, testy, ill-natured person.
'Attercop' comes from the Old English 'atorcoppe,' where 'atter' means 'poison, venom' and‎ 'cop' means 'spider.' 'Coppa' is a derivative of 'cop,' top, summit, round head, or 'copp,' cup, vessel, which refers to 'the supposed venomous properties of spiders,' says the OED. 'Copp' is still found in the word 'cobweb.'
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