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- Pharma Roundup: Lilly's Prasugrel in Europe, AstraZeneca's $900 Million Deal, and More
- EMEA backs Lilly's prasugrel, AZ pays $900 million for MAP partnership, Targanta lays off 85, Vertex's new hepatitis C drug may fetch $75,000. by John Maas
- Blog posts 2008-12-19
Additional Resources
- MethylGene and Pharmion Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Hodgkin's Lymphoma
- MethylGene, Inc. (TSX: MYG) and Pharmion (NASDAQ: PHRM) today announced that the European Medicines Agency EMEA and the European Commission EC designated MGCD0103, a histone deacetylase HDAC inhibitor, as an Orphan Medicinal Product for the treatment of Hodgkin's lymphoma in the European Union EU. Criteria for designation require that the...
- Research articles 2007-09-24
- MethylGene and Pharmion Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Acute Myelogenous Leukemia
- MethylGene Inc. (TSX: MYG) and Pharmion (NASDAQ: PHRM) today announced that the European Medicines Agency EMEA and the European Commission EC designated MGCD0103, a histone deacetylase HDAC inhibitor, as an Orphan Medicinal Product for the treatment of acute myelogenous leukemia in the European Union EU. Criteria for designation require that...
- Research articles 2008-02-11
- MethylGene and Pharmion Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Hodgkin's Lymphoma; - Follows the Companies' Previous Announcement of MGCD0103's Orphan Drug Designation for the Tre
- MONTREAL, QUEBEC AND BOULDER COLORADO, Sep 24, 2007 CCNMatthews via COMTEX -- MethylGene, Inc. (TSX:MYG) and Pharmion (NASDAQ:PHRM) today announced that the European Medicines Agency EMEA and the European Commission EC designated MGCD0103, a histone deacetylase HDAC inhibitor, as an Orphan Medicinal Product for the treatment...
- Research articles 2007-09-24
- MethylGene and Pharmion Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Acute Myelogenous Leukemia.
- MONTREAL, QUEBEC and BOULDER, COLORADO, Feb 11, 2008 Marketwire via COMTEX -- MethylGene Inc. (TSX:MYG) and Pharmion (NASDAQ:PHRM) today announced that the European Medicines Agency EMEA and the European Commission EC designated MGCD0103, a histone deacetylase HDAC inhibitor, as an Orphan Medicinal Product for the treatment...
- Research articles 2008-02-11
- Gilead Sciences Submits Marketing Authorisation Application for Aztreonam Lysine 75 mg Powder for Nebuliser Solution, a Potential New Treatment for Cystic Fibrosis, to European Medicines Agency
- FOSTER CITY, Calif. -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced the submission of a Marketing Authorisation Application MAA for marketing approval of aztreonam lysine 75 mg powder for nebuliser solution aztreonam lysine in the European Union. The MAA will be reviewed by the Committee for Medicinal Products for Human Use...
- Research articles 2008-03-07
- Bristol-Myers Squibb, Gilead Sciences and Merck & Co. Submit Marketing Authorisation Application for ATRIPLA™ to European Medicines Agency
- PRINCETON, N.J. & FOSTER CITY, Calif. & WHITEHOUSE STATION, N.J. -- Bristol-Myers Squibb Company (NYSE:BMY), Gilead Sciences, Inc. (Nasdaq:GILD) and Merck & Co., Inc. (NYSE:MRK) today announced the submission of a Marketing Authorisation Application MAA for ATRIPLATM (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) in the...
- Research articles 2006-10-09
- Introgen Therapeutics and Gendux AB Announce Agreement With European Medicines Agency to File for ADVEXIN Approval Under Exceptional Circumstance Rules.
- STOCKHOLM, Sweden and AUSTIN, Texas, October 31 /PRNewswire/ -- - European Commission Confirms ADVEXIN as Orphan Drug for Li-Fraumeni Syndrome Cancers Gendux AB and Introgen Therapeutics, Inc. (Nasdaq: INGN) announced today that they have reached agreement with the European Medicines Agency...
- Research articles 2006-10-31
- Bioenvision's Clofarabine Receives a Positive Opinion From the European Medicines Agency.
- LONDON, February 24 /PRNewswire/ -- - First European Approval for a Drug Specifically Developed to Treat Relapsed or Refractory Acute Lymphoblastic Leukaemia in Paediatric Patients Bioenvision (Nasdaq: BIVN) today announced that the European Medicines Agency has adopted a positive opinion on...
- Research articles 2006-02-24
- The European Medicines Agency (EMEA) Selects Sparta Systems' TrackWise Quality and Compliance Management Software.
- HOLMDEL, New Jersey, June 13 /PRNewswire/ -- Sparta Systems, Inc. Sparta, the leader in enterprise quality and compliance management software for the life sciences and other highly regulated industries, announced today that the European Medicines Agency EMEA, Europe's governing agency for the promotion and...
- Research articles 2006-06-13
- European Medicines Agency (EMEA) Goes Live With Sparta Systems' TrackWise Quality and Compliance Management Software.
- HOLMDEL, New Jersey, October 10 /PRNewswire/ -- Sparta Systems, Inc., the leader in enterprise quality and compliance management software for the life sciences and other highly regulated industries, announced today that the European Medicines Agency EMEA, Europe's governing agency for the...
- Research articles 2006-10-10
- Bioenvision's Clofarabine Receives a Positive Opinion from the European Medicines Agency; Bioenvision Prepares for Marketing Launch
- LONDON -- Bioenvision (Nasdaq: BIVN) today announced that the European Medicines Agency has adopted a positive opinion on the marketing authorization application for EvoltraTM clofarabine. EvoltraTM is indicated for the treatment of acute lymphoblastic leukemia ALL in pediatric patients who have relapsed or are refractory to at least two prior...
- Research articles 2006-02-23
- ZymoGenetics to Highlight Development Programs at Delafield Hambrecht Forum and Macugen(R) Receives Positive Opinion from the European Medicines Agency.
- M2 PRESSWIRE-19 September 2005-US Financial Network: ZymoGenetics to Highlight Development Programs at Delafield Hambrecht Forum and MacugenR Receives Positive Opinion from the European Medicines AgencyC1994-2005 M2 COMMUNICATIONS LTD RDATE:19092005 City of Industry, CA - Biotechnology industry news provided by Financial...
- Research articles 2005-09-19
- Omrix Biopharmaceuticals Receives Approval from European Medicines Agency for Evicel Liquid Fibrin Sealant
- NEW YORK -- OMRIX Biopharmaceuticals, Inc. ("Omrix" or the "Company") (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has received approval from the European Medicines Agency EMEA for Evicel, the Company's liquid fibrin sealant. The EMEA's approval permits EVICEL...
- Research articles 2008-10-14
- PHARMACEUTICALS: PARLIAMENT FAVOURS ARTICLE 100A FOR EC MEDICINES AGENCY
- Summary: Legal battles continue as the European Parliament adopted a report by Jose Luis Valverde Lopez (EPP, Spain) during its May 24-28 plenary session. The report calls on the Commission to change the legal basis for the Regulation establishing the European Medicines Agency to Article ...
- Research articles 1993-06-08
- U.S./European Pharmaceutical Cooperation
- The U.S. Food and Drug Administration FDA, the European Commission EC, and the European Medicines Agency EMEA announced on June 18 their agreement to expand current cooperative activities in several areas. At a meeting held June 14-15, the FDA and tThe U.S. Food and Drug Administration FDA, the European Commission...
- Research articles 2007-08-01
- Boehringer Ingelheim Submits Marketing Authorisation Application to European Union and to the FDA for Investigational Anti-HIV Agent Tipranavir.
- INGELHEIM, Germany, October 25 /PRNewswire/ -- Boehringer Ingelheim today announced the submission of a Marketing Authorisation Application MAA to the European Medicines Agency EMEA for tipranavir. Simultaneously the documentation was submitt INGELHEIM, Germany, October 25 /PRNewswire/ -- Boehringer...
- Research articles 2004-10-25
- Elan's MS drug gets European thumbs up.
- A return to the market of Elan's multiple sclerosis drug Tysabri has moved closer. The European Medicines Agency's scientific committee recommended that the drug return to the market for patients who fail to respond to beta-interferon treatment. A return to the market of...
- Research articles 2006-05-05
- European agency warns of possible Botox side effects
- BERLIN AFP — Months after US authorities sounded the alarm, European officials are warning of dangerous possible side effects from the wrinkle-smoothing injection Botox, according to a German news report. The London-based European Medicines Agency had by August 2007 recorded more than 600 cases of negative effects potentially linked...
- Research articles 2008-08-31
- European regulators approve breast cancer drug: GSK
- LONDON AFP — British pharmaceutical firm GlaxoSmithKline said on Thursday that European regulators had given marketing approval for its tablet breast cancer drug Tyverb. "GlaxoSmithKline announced today that the European Commission has granted a conditional marketing authorisation for Tyverb ... for all 27 European Union member states," GSK said...
- Research articles 2008-06-12
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