MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'emea'. Sat, 03 Sep 2011 02:27:21 +0100 http://www.medworm.com/index.php?rid=3552545&cid=t_97466_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FI42DKu7h6mE%2F The European Medicines Agency (EMEA) recently refused to release documents containing suspected adverse reactions caused by Accutane (which is called Roaccutane in the UK), after a law firm in two years ago Ireland requested info that dated back to 1992. At issue were reports linking the acne drug to suicidal tendencies, a topic that has been the subject of controversy and litigation for years (see here). And so European Ombudsman Nikiforos Diamandouros yesterday vigorously disagreed with the EMEA argument that transparency rules do not apply to these reports. “EMEA plays a crucial role in the approval and monitoring of medicines placed on the market,” he said in a statement. “Since its work has a direct impact on the health of European citizens, it is of utmost importanc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3552545 Tue, 11 May 2010 12:42:17 +0100 3552545 http://www.medworm.com/index.php?rid=1552175&cid=t_97466_87_f&fid=36224&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F320841127%2F European drug regulators said today that cancer patients with a “reasonably long life-expectancy” should get blood transfusions rather than take anemia drugs. A statement from the European Medicines Agency (EMEA) is online here. Anemia is a common side effect of chemotherapy, and anemia drugs such as Amgen’s Aranesp and Johnson & Johnson’s Procrit (sold in Europe as Eprex) are often used as an alternative to blood transfusions. But some studies suggest the drugs may increase the risk of tumor progression and shorten life. Sales of the drugs have already been hammered in this country by safety concerns; earlier this year, an FDA advisory committee said the drugs shouldn’t be given to cancer patients receiving potentially curative treatments. Still, JP Morg... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=1552175 Sat, 28 Jun 2008 17:41:33 +0100 1552175 http://www.medworm.com/index.php?rid=1551901&cid=t_97466_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F321266408%2F The director of Italy’s medicines regulatory agency has been suspended along with another top official, as the drug licenses-for-cash scandal surrounding the organization continues to unfold, PharmaTimes writes. Nello Martini, director of Aifa (the Italian Agency for Pharmaceuticals), has been suspended along with Caterina Gualano, head of medicines registration for the agency. The development follows a two-year investigation in which police found evidence that money had changed hands in return for the falsification of clinical data required for drug licences. Last month, Pasqualino Rossi, one of Aifa’s most senior reps at the European Medicines Agency, had been arrested along with another Aifa official and five pharma lobbyists. The scandal has engulfed Bayer and Glaxo, and em... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1551901 Fri, 27 Jun 2008 11:42:35 +0100 1551901 http://www.medworm.com/index.php?rid=1547190&cid=t_97466_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F320841127%2F European drug regulators said today that cancer patients with a “reasonably long life-expectancy” should get blood transfusions rather than take anemia drugs. A statement from the European Medicines Agency (EMEA) is online here. Anemia is a common side effect of chemotherapy, and anemia drugs such as Amgen’s Aranesp and Johnson & Johnson’s Procrit (sold in Europe as Eprex) are often used as an alternative to blood transfusions. But some studies suggest the drugs may increase the risk of tumor progression and shorten life. Sales of the drugs have already been hammered in this country by safety concerns; earlier this year, an FDA advisory committee said the drugs shouldn’t be given to cancer patients receiving potentially curative treatments. Still, JP Morg... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=1547190 Thu, 26 Jun 2008 23:01:31 +0100 1547190 http://www.medworm.com/index.php?rid=1531701&cid=t_97466_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D2131 At a session on Wednesday afternoon, Richard Friedman of CDER discussed FDA and foreign inspections of manufacturing sites, and mentioned proposed solutions that would harmonize requirements and lighten the load, while maintaining standards.  They include a global system of surveillance and mutual inspectorate acceptance.  In this plan, FDA and EU inspectors who had inspected certain [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1531701 Fri, 20 Jun 2008 15:01:16 +0100 1531701 http://www.medworm.com/index.php?rid=1482545&cid=t_97466_136_f&fid=36051&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fb5media%2FCancerCommentary%2F%7E3%2F301841391%2F ERBITUX® (Cetuximab) - product of Merck KGaA and ImClone Systems Inc. - has received EU backing as first-line treatment for colon cancer. According to the European Medicines Agency: Erbitux can be given as the first drug in colon-cancer treatment in patients who carry an unmutated kras gene, restricting its use to about 65 percent of patients. Erbitux is the first monoclonal antibody approved by the US FDA for the treatment of advanced colon cancer that has spread to the other parts of the body — either alone or in combination with other treatments. Read more about the EU backing on Erbitux from Bloomberg. Tags: colon-cancer, EMEA, ERBITUX® (Cetuximab), ImClone Systems Inc., MErck KGaAShare This (Source: Cancer Commentary) Cancer Commentary blogs http://www.medworm.com/rss/comments.php?id=1482545 Sat, 31 May 2008 12:53:29 +0100 1482545 http://www.medworm.com/index.php?rid=1464201&cid=t_97466_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F296516175%2F A drug licences-for-cash scandal has engulfed Italy’s medicines regulatory agency with leading officials arrested along with people linked to major drugmakers, PharmaTimes writes. The most senior figure to have been held is Pasqualino Rossi, vp of Aifa, the Italian Agency for Pharmaceuticals, and one of Italy’s most senior reps at the European Medicines Agency. Five lobbyists have also been arrested, and an eighth person is being sought. Arrest warrants were issued after an investigating judge saw a 400-word police report suggesting money had changed hands in return for falsifying clinical data required for drug licences, according to PharmaTimes. At issue are licenses awarded to around 30 meds, mostly generics. The two-year investigation used wiretaps and covert cameras. The s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1464201 Fri, 23 May 2008 12:05:19 +0100 1464201 http://www.medworm.com/index.php?rid=908785&cid=t_97466_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F162085546%2F The crisis continues for Amgen ceo Kevin Sharer. Now, the European Medicines Agency, or EMEA, is proposing special warnings and reduced dosing recommendations for Amgen’s top-selling Aranesp and Epogen, as well as Johnson & Johnson’s Procrit (or Eprex). New prescribing info may say studies show more deaths associated with increased dosing of anemia meds and that the drugs haven’t been shown to improve overall survival in cancer patients with anemia. An EMEA panel recommends that anemia drugs be given to boost hemoglobin levels to 10 to 12 grams per deciliter of blood, according to an Amgen statement. Previously guidance ranged from 11 to 14 grams, in kidney failure patients; the ceiling was 13 for cancer patients. Earlier this month, an FDA panel voted to keep the m... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=908785 Thu, 27 Sep 2007 17:40:39 +0100 908785 http://www.medworm.com/index.php?rid=604135&cid=t_97466_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F114969525%2Fabbott_seeks_approval_of_first.html Abbott (NYSE: ABT) has simultaneously submitted regulatory applications for its drug product HUMIRA® (adalimumab): a supplemental Biologics License Application (sBLA) with the USFDA seeking approval to market HUMIRA® (adalimumab) as a treatment for juvenile rheumatoid arthritis (JRA) in the U.S. a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA® (adalimumab) as a treatment for juvenile idiopathic arthritis (JIA) in the European Union (EU). The above regulatory applications are the first pediatric indication being sought for HUMIRA®. JRA, commonly referred to as JIA in the EU, is the most common form of arthritis in children and normally begins before the age of 16. Typical symptoms include persistent joint pain and stiffness tha... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=604135 Tue, 08 May 2007 06:16:36 +0100 604135 http://www.medworm.com/index.php?rid=556183&cid=t_97466_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F110613072%2Fallos_therapeutics_pdx_pralatr.html Allos Therapeutics, Inc. (Nasdaq: ALTH)’s novel antifolate PDX (pralatrexate) for the treatment of patients with peripheral T-cell lymphoma (PTCL) has been granted Orphan Drug Designation by the European Medicines Agency (EMEA). PDX is a novel, small molecule chemotherapeutic agent that inhibits dihydrofolate reductase, or DHFR, a folic acid (folate)-dependent enzyme involved in the building of nucleic acid, or DNA, and other processes. PDX was rationally designed for efficient transport into tumor cells via the reduced folate carrier, or RFC-1, and effective intracellular drug retention. PDX has been awarded the USFDA orphan drug designation in July 2006 for the treatment of patients with T-cell lymphoma and in October 2006 has been granted FDA fast track designation for the treatm... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=556183 Fri, 20 Apr 2007 14:37:01 +0100 556183 http://www.medworm.com/index.php?rid=538579&cid=t_97466_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F108372412%2Fnovagali_pharmas_vekacia_passe.html Headquartered in the Genopole biocluster in Evry, France, Novagali Pharma is an emerging ophthalmic pharmaceutical company specialized in ophthalmology. Its product candidate for Vernal Keratoconjunctivitis (VKC) - Vekacia® - has recently passed pivotal Phase III clinical trial. Vekacia® is a topical Cyclosporine A cationic emulsion enabling an efficient and unmatched-level drug absorption in tissues of the eye leading to optimal therapeutic efficacy. This proprietary ophthalmic emulsion of Cyclosporine A will be the first therapeutic product dedicated to treatment of such a severe ocular condition. VKC, a rare and severe form of chronic allergic conjunctivitis, is characterized by ocular discomfort, pain, itching and intense photophobia, affecting mostly children and young adults ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=538579 Wed, 11 Apr 2007 22:37:30 +0100 538579 http://www.medworm.com/index.php?rid=517807&cid=t_97466_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F106184764%2Fgsk_submitted_eu_regulatory_ap.html GlaxoSmithKline (NYSE: GSK) has submitted regulatory approval to the European Medicines Agency (EMEA) under Article 58 for the combination vaccine candidate Globorix™ (diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, Neisseria meningitides serogroups A and C). The conjugate meningococcal vaccine has demonstrated a good safety profile and immunogenicity (in clinical trials including countries in Africa and Asia) against meningococcal meningitis caused by Neisseria meningitidis serogroups A and C in addition to five other major childhood diseases. According to Jean Stephenne, President of GlaxoSmithKline Biologicals: "GSK's long-standing commitment to the developing world is reflected in the development of Globorix™, a vaccine designed spe... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=517807 Tue, 03 Apr 2007 03:09:04 +0100 517807 http://www.medworm.com/index.php?rid=508524&cid=t_97466_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F105100180%2Fremicade_recommended_for_appro.html Co-developed by Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP), REMICADE® (infliximab) was first approved in the U.S. ( by the USFDA) in 1998 as treatment U.S. for adult Crohn's disease (CD) and later, in 2005, for adult ulcerative colitis. REMICADE® is a monoclonal antibody that specifically targets TNF-alpha, which has been shown to play a role in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC) and psoriasis (PsO). REMICADE® is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and the only agent approved for the treatment of both RA and CD in North America, the EU and Japan.The USFDA approval of REMICADE® in May 2006 for pediatric patien... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=508524 Thu, 29 Mar 2007 08:12:58 +0100 508524 http://www.medworm.com/index.php?rid=502964&cid=t_97466_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F104654103%2Femea_recommends_oral_cancer_dr.html The European Medicines Agency (EMEA) has granted a positive opinion on Celgene Corporation (Nasdaq: CELG)’s novel oral cancer drug REVLIMID® (lenalidomide) for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy. EMEA's Committee for Medicinal Products for Human Use (CHMP) has already forwarded its recommendation of approval for the said drug to the European Commission – the body who issues the final marketing approval in 2-3 months time. Already approved by the USFDA as a treatment in combination with dexamethasone for patients previously treated with multiple myeloma, REVLIMID® has obtained Orphan Drug designation in the EU, US and Australia. Find more details from the full report. (S... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=502964 Tue, 27 Mar 2007 09:12:01 +0100 502964