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Headline pharmaceutical news | 11/03/2010 10.22.58
  • Ag Groups Weigh-in On Supreme Court Case For Biotech Alfalfa
    The U.S. Supreme Court will decide whether a lower court acted hastily and incorrectly by banning the cultivation of biotech alfalfa despite extensive scientific evidence documenting the safety of the crop. A coalition of agricultural organizations filed on March 8 a joint friend-of-the-court brief to the Supreme Court in support of the petitioners in "Monsanto Co. v. Geertson Seed Farms...

  • Supreme Court To Consider Legality Of Lawsuits Against Vaccine Makers
    The Associated Press: "The Supreme Court will decide whether drug makers can be sued by parents who claim their children suffered serious health problems from vaccines...

  • Cellectar Completes Enrollment In Phase I Clinical Trial Of Lead Drug Candidate (131)I-CLR1404 For The Treatment Of Solid Malignancies
    Cellectar, Inc., a privately held radiopharmaceutical company that designs and develops products to detect, treat and monitor human cancers, announced that enrollment for its Phase I dosimetry trial for its lead drug candidate, (131)I-CLR1404 has been completed. Results of this trial will be used to set the starting dose in a follow-on Phase I dose escalation study planned for later this year...

  • Intentional Variation Increases Result Validity In Mouse Testing
    For decades, the traditional practice in animal testing has been standardization, but a study involving Purdue University has shown that adding as few as two controlled environmental variables to preclinical mice tests can greatly reduce costly false positives, the number of animals needed for testing and the cost of pharmaceutical trials...

  • Research Finds Shortcomings In Comparative Effectiveness Drug Research
    An analysis by researchers at the Keck School of Medicine of the University of Southern California (USC) has found that only 32 percent of medication studies published in top medical journals compare the effectiveness of existing treatments. These studies, known as comparative effectiveness studies, help doctors know which therapies work best and under what circumstances they are most effective...

  • New Evidence Further Validates Ketone Body Therapy As An Effective Approach In Managing Alzheimer's Disease
    Accera, Inc., a biotechnology company delivering breakthrough therapies in central nervous system diseases, announced data which showed that augmentation with ketone bodies significantly improved cognitive function in Alzheimer's disease (AD) patients. An early feature of AD is region specific declines in cerebral glucose metabolism...

  • The Side-Out Foundation Hopes To Score Big With Its First Funded Breast Cancer Clinical Trial
    The Side-Out Foundation, which pairs volleyball enthusiasts with breast cancer researchers, is sponsoring a new clinical trial for up to 25 patients with advanced breast cancer. TGen Drug Development (TD2) will manage this pilot study for the Side-Out Foundation at two locations: TGen Clinical Research Services (TCRS) at Scottsdale Healthcare in Scottsdale, Ariz...

  • Chimerix Initiates Phase 2 Study Of CMX001 In Stem Cell Transplant Recipients Seropositive For Cytomegalovirus
    Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, announced the initiation of a multi-center Phase 2 clinical trial designed to evaluate CMX001 in stem cell transplant recipients who are seropositive for cytomegalovirus (CMV). CMX001 is a broad-spectrum antiviral agent with demonstrated activity against double-stranded DNA (dsDNA) viruses...

  • William A. Hawkins, Medtronic Chairman And CEO, Receives Distinguished Achievement Award From Biomedical Engineering Society
    Medtronic, Inc., (NYSE: MDT), announced William A. Hawkins, chairman and CEO, recently received the Biomedical Engineering Society's Distinguished Achievement Award. As part of the award, the plenary lecture he delivered to the organization was published in the March 2010 edition of the Annals of Biomedical Engineering...

  • The Potential For Using Algae To Produce Human Therapeutic Proteins
    Pharmaceutical companies could substantially reduce the expense of costly treatments for cancer and other diseases produced from mammalian or bacterial cells by growing these human therapeutic proteins in algae - rapidly growing aquatic plant cells that have recently gained attention for their ability to produce biofuels...

  • Computer Reminders For Physicians Less Effective Than Expected
    Computer reminders to physicians regarding prescribing produce much smaller improvements than initially expected, found a study in CMAJ (Canadian Medical Association Journal). Computerized systems for entering orders and electronic medical records are the two most widely recommended improvements in health care...

  • Science World Charmed By Snake Venom
    The King Cobra continues to weave its charm with researchers identifying a protein in its venom with the potential for new drug discovery and to advance understanding of disease mechanisms. The novel protein named haditoxin has been described in the prestigious Journal of Biological Chemistry (March 12, 2010)...

  • Nektar Announces Positive Phase 2 Clinical Data From First Stage Of NKTR-102 Study In Women With Platinum-Resistant Ovarian Cancer
    Nektar Therapeutics (Nasdaq: NKTR) announced preliminary progression-free survival data from the first stage of a two-stage Phase 2 clinical study evaluating single-agent treatment with NKTR-102 in women with platinum-resistant ovarian cancer...

  • NOVAVAX Completes Enrollment Of Pivotal H1N1 Influenza Vaccine Clinical Trial In Mexico
    Novavax, Inc. (Nasdaq: NVAX) announced that the enrollment of over 3,500 subjects in Mexico has been completed in Stage B of its pivotal 2009 H1N1 virus-like-particle (VLP) pandemic influenza vaccine study. With the 1,000 subjects already enrolled in Stage A of the trial, the enrollment in this pivotal trial is now complete with over 4,500 subjects...

  • Acologix Presents Data On Cartilage Regeneration By AC-100 At The 56th Annual Meeting Of The Orthopaedic Research Society
    Acologix, Inc., a privately held biopharmaceutical company, announced the results of its latest preclinical study demonstrating that AC-100, its therapeutic product candidate derived from an endogenous human protein, promotes cartilage regeneration in a large animal model. The data will be presented by Dr. David M...

  • Peptimmune Announces Second Grant Of A United States Patent For PI-2301 Peptide Copolymer For Multiple Sclerosis
    Peptimmune, Inc. a privately held biotechnology company, announced the grant of US Patent Number 7,655,221 (the '221 patent) which protects the target product profile for its PI-2301 peptide copolymer for the treatment of multiple sclerosis, and other autoimmune diseases. The '221 patent claims important treatment modalities for PI-2301 and related compounds...

  • Selective Automation A Must For Clinical Labs To Remain Competitive
    While clinical laboratories are vital to the diagnostic industry, they are facing multiple challenges that will require increased automation in order for them to remain competitive...

  • Poniard Pharmaceuticals Presents Positive Survival Data From A Phase 2 Clinical Study Of Picoplatin In Metastatic Prostate Cancer
    Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, announced the presentation of positive final data, including survival data, from the Company's Phase 2 clinical trial of picoplatin as a first-line therapy in men with metastatic castration-resistant (hormone-refractory) prostate cancer (CRPC)...

  • InterMune Announces Posting Of Briefing Documents For FDA Advisory Committee Meeting On Pirfenidone
    InterMune, Inc. (Nasdaq: ITMN) announced that the U.S...

  • ISIS Initiates Phase 1 Clinical Trial Of ISIS-SOD1Rx In Patients With ALS
    Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced that it has initiated a Phase 1 study of ISIS-SOD1Rx in patients with an inherited, aggressive form of Lou Gehrig's disease also known as familial amyotrophic lateral sclerosis (ALS). Approximately 20 percent of all familial ALS cases are caused by a mutant form of superoxide dismutase, or SOD1...

  • Phase III REGION-I Study Shows PEP005 (ingenol Mebutate) Gel 0.05% May Reduce Pre-Cancerous Skin Lesions In Patients With Actinic Keratosis
    Specialty pharmaceutical company LEO Pharma announced that findings from a Phase III study evaluating PEP005 (ingenol mebutate) Gel 0.05% to treat actinic keratosis (AK), a common pre-cursor to skin cancer, were presented at the 68th Annual Meeting of the American Academy of Dermatology (AAD) (Scientific Session Poster Discussion: P105)...

  • FDA Approves Name Change For Heartburn Drug Kapidex
    The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex (dexlansoprazole) to avoid confusion with two other medications - Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new name Dexilant...

  • 2010 BIO International Convention Expected To Bring More Than $25 Million To Chicago
    The Biotechnology Industry Organization announced that the 2010 BIO International Convention is expected to contribute more than $25 million to the local economy, according to estimates from the Chicago Convention and Tourism Bureau. The BIO International Convention returns to Chicago May 3-6 and is expected to draw 15,000 to 17,000 industry leaders from 48 states and 60 countries...

  • Key Caldolor(R) Orthopedic Data To Be Presented At American Academy Of Orthopaedic Surgeons' Annual Meeting
    Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced that results from a clinical trial of Caldolor® (ibuprofen) Injection will be presented at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) in New Orleans, Louisiana...

  • Gynecologic Oncology Group Notifies CTI That Continuation Of GOG-212 Pivotal Trial Of OPAXIO Maintenance Therapy In Ovarian Cancer Is A Priority
    Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced that CTI received a statement on March 1, 2010 from the Gynecologic Oncology Group (GOG) leadership that the phase III GOG-212 clinical trial of CTI's OPAXIO™ used as maintenance therapy for ovarian cancer remains a high priority and enrollment will continue...

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