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Biotechnology/Pharmaceutical News

  • Jackson doctor denies manslaughter charge (AFP)

    AFP - Michael Jackson's doctor pleaded not guilty to involuntary manslaughter...



  • AstraZeneca gets OK for expanded Crestor use (AP)
    AP - Federal regulators have granted AstraZeneca approval to market its chole...

  • Charles River reports profit, but revenue slides (AP)
    AP - Medical research equipment and services company Charles River Laboratori...

  • Lechleiter pay rises in 1st full year as Lilly CEO (AP)
    AP - Eli Lilly and Co. CEO John Lechleiter received a compensation package va...

  • CVS Caremark profit tops view; shares up 6 percent (Reuters)

    Reuters - CVS Caremark Corp said recent problems at its pharmacy benefits ma...



  • CVS Caremark 4Q profit grows 11 percent (AP)

    AP - CVS Caremark Corp., one of the nation's biggest drugstore operators, sai...



  • Earnings Preview: CVS Caremark to report 4Q (AP)
    AP - Drugstore operator and pharmacy benefits manager CVS Caremark Corp. repo...

  • Teva Pharma settles some Medicaid drug price suits (AP)
    AP - Teva Pharmaceutical Industries Ltd., the world's largest generic drugmak...

  • Miss. settles Zyprexa suit for more than $18M (AP)
    AP - Mississippi will receive $18.5 million from drug maker Eli Lilly and Co....

  • GlaxoSmithKline hints at job cuts as profits soar (AFP)

    AFP - British pharmaceuticals giant GlaxoSmithKline on Thursday announced a 6...



  • Drugmaker employee in NY charged with trade theft (AP)
    AP - A fired Bristol-Myers-Squibb Co. employee stole trade secrets from the d...

  • Ironwood shares rise after IPO prices low (AP)
    AP - Shares of Ironwood Pharmaceuticals Inc. are up in their IPO debut after ...

  • FDA News

  • FDA Updates Statement on the Investigation into the Salmonella Montevideo Out...
    The Food and Drug Administration, along with the Centers for Disease Control ...

  • FDA Issues Guidance to Help Streamline Medical Device Clinical Trials
    The U.S. Food and Drug Administration today issued guidance on Bayesian stati...

  • United States Seizes more than 1500 Cases of Food from Wisconsin Distribution...
    At the request of the U.S. Food and Drug Administration, U.S. Marshals on Tue...

  • FDA Approves Xiaflex for Debilitating Hand Condition
    The U.S. Food and Drug Administration today approved Xiaflex (collagenase clo...

  • FDA Requests $4.03 Billion to Transform Food Safety System, Invest in Medical...
    The U.S. Food and Drug Administration is requesting $4.03 billion to promote ...

  • FDA Announces Safety Risk Associated with HIV Drug
    The U.S. Food and Drug Administration today announced that non-cirrhotic port...

  • FDA Collaboration Seeks to Speed Development of Pneumococcal Vaccines for Chi...
    The U.S. Food and Drug Administration (FDA) today announced a collaboration w...

  • FDA Statement on the Investigation into the Salmonella Montevideo Outbreak
    The Food and Drug Administration, along with the Centers for Disease Control ...

  • FDA Expands Use of Approved Breast Cancer Drug
    The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in co...

  • United States Seizes Unapproved Ozone Generators
    At the request of the U.S. Food and Drug Administration, U.S. Marshals today ...

  • FDA Announces Class I Recall of Certain Infusion Set Needles
    The U.S. Food and Drug Administration today announced a Class I recall of Exe...

  • FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain
    The U.S. Food and Drug Administration today approved Morphine Sulfate Oral So...


  • New Drug Applications

  • XenoPort Announces Horizant as Brand Name for XP13512
    SANTA CLARA, Calif.--(BUSINESS WIRE)--Feb 4, 2010 - XenoPort, Inc. announced ...

  • Lux Biosciences Files for Luveniq Approval in US and Europe for Noninfectious...
    JERSEY CITY, N.J.--(BUSINESS WIRE)--Feb 4, 2010 - Lux Biosciences, Inc. today...

  • FDA Accepts Javelin Pharmaceuticals' Dyloject New Drug Application for Formal...
    NDA for Management of Acute Moderate-to-Severe Pain Includes Data from 16 Cli...

  • Teva Announces FDA Accepts BLA for XM02
    JERUSALEM--(BUSINESS WIRE)--Feb 2, 2010 - Teva Pharmaceutical Industries Ltd....

  • Protalix Announces NDA Submission Update for taliglucerase alfa for the Treat...
    CARMIEL, Israel, Feb. 2 /PRNewswire-FirstCall/ -- Protalix BioTherapeutics, I...

  • FDA Extends PDUFA Action Date for Stedesa New Drug Application
    MARLBOROUGH, Mass.--(BUSINESS WIRE)--Jan 27, 2010 - Sepracor Inc. today annou...

  • FDA Issues Complete Response Letter for Low Dose Oral Contraceptive WC 3016
    ARDEE, Ireland, Jan. 27 /PRNewswire-FirstCall/ -- Warner Chilcott plc announc...

  • Somaxon Provides Update on New Drug Application for Silenor for the Treatment...
    Resubmission has been filed, with 2 month review cycle SAN DIEGO--(BUSINESS W...

  • Genzyme's Lumizyme BLA Receives Six-Month FDA Review
    PDUFA Date Set For June 17, 2010 CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan 21, 2...

  • MannKind Updates Status of Afrezza New Drug Application
    VALENCIA, Calif.--(BUSINESS WIRE)--Jan 8, 2010 - MannKind Corporation announc...

  • Clinical Trials

  • AMAG Pharmaceuticals Provides Feraheme® Safety Update
    ~ Conference call will be held today at 4:45 p.m. Eastern time ~ LEXINGTON, M...

  • Researchers Report Elevated Levels of Tβ4 Levels Predict Patient Surviv...
    Tβ4 – Potential New Therapeutic Agent for Liver Failure BETHESDA, Md.--...

  • NOVAVAX Reports Additional Positive Data from Its Trivalent Seasonal Influenz...
    Data show significant Neuraminidase Inhibition Antibody Titers in VLP vaccine...

  • Addex Pharmaceuticals (CH) - Addex: ADX71943 Demonstrates Analgesic Effects i...
    Geneva, Switzerland, 8 February 2010 - Addex Pharmaceuticals (SIX:ADXN), the...

  • Cara Therapeutics Reports Positive Phase II Data for Novel Peripheral Analges...
    SHELTON, Conn., Feb. 8 /PRNewswire/ -- Cara Therapeutics, Inc. today announce...

  • Synta Announces STA-9090 Results Demonstrating Potent in vitro and in vivo Ac...
    - Results presented at hematologic malignancies conference in Singapore - - S...

  • Inovio Biomedical Cervical Cancer Therapeutic Vaccine Generates Dose-Related ...
    Increased antigen-specific T-cell and antibody responses shown in second, hig...

  • Inovio's Cervical Cancer Therapeutic Vaccine Generates Dose-Related Immune Re...
    Increased antigen-specific T-cell and antibody responses shown in second, hig...

  • LEO Pharma's PEP005 Meets Primary Endpoint in Phase III Trial for Pre-Cancero...
    BALLERUP, Denmark, Feb. 1 /PRNewswire-USNewswire/ -- LEO Pharma today announc...

  • Shire to Present Important Study Findings for Gaucher Disease Treatment and G...
    Data sponsored by the Canadian Fabry Disease Initiative (CFDI) to be presente...

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