Medicine News

• BYETTA Approved For Expanded Use As First-Line Treatment For Type 2 Diabetes
  Sat, 31 October 2009
  Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA (exenatide) injection. BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve ...
• U.S. Food And Drug Administration Issues Complete Response Letter Regarding PEGINTRON(R) ...
  Sat, 31 October 2009
  Schering-Plough Corp. (NYSE: SGP) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete l ...
• AcelRx Announces Successful Completion Of End-of-Phase 2 Meeting On ARX-01, Sufentanil N ...
  Sat, 31 October 2009
  AcelRx Pharmaceuticals, Inc announced that it has successfully completed an End-of-Phase 2 meeting with the FDA for ARX-01, a drug/device combination product based on the company's proprietary NanoTab(TM) dosage form, which enables delivery of sufentanil by the non-invasive oral transmucosal (sublingual) route. ARX-01 offers ...
• Global Phase III Study Results Show Eribulin Meets Primary Endpoint Of Overall Survival
  Sat, 31 October 2009
  Eisai Inc. announced preliminary results from a recently completed Phase III study with eribulin mesylate (E7389), discovered and developed by the company, in patients with locally advanced or metastatic breast cancer.
• Sunesis Completes Enrollment Of Voreloxin REVEAL-1 Trial In Acute Myeloid Leukemia
  Sat, 31 October 2009
  Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported that it has completed enrollment in the REVEAL-1 (Response Evaluation of VorEloxin in AmL) trial, a Phase 2 dose regimen optimization trial of single agent voreloxin in newly diagnosed elderly acute myeloid leukemia (AML) patients who are unlikely to benefit from standard ...
• Idenix Pharmaceuticals Presents Data On IDX184 For The Treatment Of Hepatitis C Virus (HCV)
  Sat, 31 October 2009
  Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, announced presentations of data on IDX184, a once-daily novel liver-targeted nucleotide prodrug of 2'-methyl guanosine (2'MeG) for the treatment of HCV, at the ...
• Bayer HealthCare Presents Florbetaben Phase II Study Results At World Congress Of Neurology
  Sat, 31 October 2009
  Bayer HealthCare presented results from a global Phase II study of florbetaben, its imaging agent in development for the detection of cerebral beta-Amyloid plaques, at the 19th World Congress of Neurology (WCN). The purpose of the Phase II study was to investigate the efficacy of florbetaben in differentiating between pat ...
• NovaBay's Aganocides Show Penetration And Efficacy In A Pre-Clinical Infected Human Nail ...
  Sat, 31 October 2009
  NovaBay Pharmaceuticals, Inc. (NYSE-Amex: NBY) announced that its Aganocide compounds demonstrate potent antifungal activity in an established pre-clinical infected nail model of onychomycosis. The study data will be presented tomorrow at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Philade ...
• Shire Reports Tolerability And Clinical Effects Results Of Daytrana(R) (methylphenidate ...
  Sat, 31 October 2009
  Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced findings at a major medical meeting from a Phase IIIb study of the tolerability and effectiveness of Daytrana (methylphenidate transdermal system) in adolescents aged 13 to 17 years diagnosed with Attention-Deficit/Hyperactivity D ...
• Quantitative Model-Based Drug Development At The AAPS Workshop
  Sat, 31 October 2009
  Educational event to take place prior to 2009 AAPS Annual Meeting and Exposition WHO: The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific society of approximately 12,000 members employed in industry, academia, government and other research institutes worldwide. Founded in 1986, AAPS ...