Contract-Resource-Outsourcing-IndustryNews

  1. FDA Approves GARDASIL® For Use In Boys And Young Men 10/16/2009
    Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.
  2. Two Phase III Studies Of Lucentis Show Early And Sustained Improvement In Vision In Patients With Retinal Vein Occlusion 10/12/2009
    Genentech, Inc., a wholly-owned member of the Roche Group, recently announced results from two Phase III studies of Lucentis (ranibizumab injection) in macular edema due to retinal vein occlusion (RVO), which showed, on average, patients given either of two doses of Lucentis had a clinically and statistically significant improvement in vision as measured by the primary endpoint of mean change from baseline in best-corrected visual acuity (BCVA) at six months compared to patients receiving sham injections. Results from both trials were presented today at the Retina Congress 2009 meeting.
  3. NextPharma Technologies Partners With CARBOGEN AMCIS In Alliance Which Combines Investigational Medicinal Product And Active Pharmaceutical Ingredient Services For Highly Potent Active Pharmaceutical Ingredients 10/8/2009
    NextPharma, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotechnology industries, is pleased to announce that it has entered into an agreement with CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, to provide customers with seamless development services covering highly potent pharmaceutical ingredient (APIs) and Investigational Medicinal Products (IMPs) for clinical trials.
  4. Boehringer Ingelheim`s Diabetes Pipeline Continues To Advance As The Company Announces Conclusion Of Robust Phase III Pivotal Trials Programme For Linagliptin 9/30/2009
    Following the release of linagliptin Phase II data earlier this year, Boehringer Ingelheim has now announced the conclusion of the linagliptin pivotal Phase III clinical trials.
  5. Cytopia's CYT387 Receives FDA Clearance To Start US Clinical Trials 9/8/2009
    Cytopia Limited’s Investigational New Drug Application (IND) for CYT387 has passed US Food and Drug Administration (FDA) review. CYT387 is a small-molecule oral JAK1/JAK2 kinase inhibitor designed to treat various haematological disorders.
  6. Bayer And Algeta Enter Global Agreement For Development And Commercialization Of Treatment For Bone Metastases In Cancer Patients 9/8/2009
    Bayer Schering Pharma AG, Germany has entered into a global agreement with Algeta ASA, Oslo, Norway for the development and commercialization of Alpharadin, a novel alpha-emitting radiopharmaceutical, based on radium-223. Alpharadin is currently being evaluated in a global Phase III trial for the treatment of bone metastases in symptomatic hormone-refractory prostate cancer (HRPC) patients.
  7. SynCo Bio Partners Enters The Japanese Market As It Signs Its First Agreement With A Japanese Pharmaceutical Company 9/2/2009
    SynCo Bio Partners B.V., the expert in long term GMP contract manufacturing of biopharmaceuticals announced recently that it has expanded its business into a new geographical market, with the signing of a contract to manufacture a live biotherapeutic for an emerging Japanese pharmaceutical company.
  8. XSpray Launches GMP Production Facility 9/1/2009
    XSpray Microparticles AB, the Swedish life science technology company, today announced the launch of its new GMP production facility in Malmö, Sweden.
  9. Groundbreaking Results In The RE-LY Trial - Novel Oral Direct Thrombin Inhibitor Dabigatran Etexilate Convincingly Beats Warfarin - Superior Stroke Reduction With Less Bleeding! 9/1/2009
    Boehringer Ingelheim recently announced data from the landmark RE-LY study - the largest atrial fibrillation (AF) outcomes trial ever conducted (18,113 patients in 44 countries worldwide) - presented for the first time at the European Society of Cardiology Congress and published online in the New England Journal of Medicine.
  10. Merck CEO Announces Structure And Global Leadership Team For New Merck 9/1/2009
    Richard T. Clark, chairman, president and chief executive officer of Merck & Co., Inc. recently announced a new organizational structure and named top management and senior leaders for the new Merck effective upon completion of the merger of Merck & Co., Inc. and Schering-Plough Corporation. Mr. Clark was named CEO of the combined company when the merger agreement was signed in March.