Trials & Filings

  • Genentech aBCC Drug Meets Phase II Endpoint

    March 21, 2011
    Genentech’s Phase II study of its investigational Hedgehog Pathway Inhibitor, vismodegib (RG3616/GDC-0449), showed positive results in people with advanced basal cell carcinoma (aBCC), a severe form of skin cancer.

  • RegeneRx AMI Trial Placed on Clinical Hold

    March 16, 2011
    RegeneRx Biopharmaceuticals, Inc. has received a notice from the FDA indicating that, due to non-compliance with cGMP regulations by its contract manufacturer, the company’s Phase II trial of RGN-352 has been placed on clinical hold.

  • Incyte, Novartis Ruxolitinib Trial Shows Promise

    March 15, 2011
    Incyte Corporation’s COMFORT-II, the second Phase III trial of investigational Janus kinase (JAK) inhibitor, ruxolitinib, has met its primary endpoint of significantly reducing spleen size in patients with myelofibrosis.

  • Tolerx, GSK Diabetes Study Misses Endpoint

    March 11, 2011
    Tolerx and GlaxoSmithKline’s Phase III DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint in patients with new-onset autoimmune type 1 diabetes.

  • Sanofi, Regeneron Lung Cancer Trial Misses Endpoint

    March 11, 2011
    Sanofi-aventis and Regeneron Pharmaceuticals’ Phase III VITAL trial evaluating the investigational drug aflibercept (VEGF Trap) for the second-line treatment of non-small cell lung cancer (NSCLC) showed that adding aflibercept to the chemotherapy dr

  • FDA Approves Benlysta for Lupus

    March 10, 2011
    Human Genome Sciences, Inc. and GlaxoSmithKline received approval from the FDA for Benlysta (belimumab) for the treatment of autoantibody-positive systemic lupus erythematosus (SLE) in patients receiving standard therapy.

  • Stemline AML Drug Gains Orphan Status

    March 9, 2011
    Stemline Therapeutics’ lead compound SL-401, has received Orphan Drug designation from FDA for the treatment of acute myeloid leukemia (AML).

  • FDA Accepts Dapagliflozin NDA

    March 8, 2011
    Bristol-Myers Squibb and AstraZeneca’s NDA for dapagliflozin, an investigational drug for the treatment of type 2 diabetes, has been accepted by the FDA.

  • Lucentis Meets Phase III Endpoint in DME

    February 14, 2011
    Genentech’s Phase III study evaluating monthly Lucentis (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint.

  • BrainStorm’s NurOwn Gets Orphan Status

    February 14, 2011
    BrainStorm Cell Therapeutics, Inc. has been granted orphan drug designation for its NurOwn autologous adult stem cell candidate for the treatment of amyotrophic lateral sclerosis (ALS), referred to as Lou Gehrig's Disease.

  • BioSante’s LibiGel Shows Positive Safety Profile

    February 14, 2011
    BioSante Pharmaceuticals, Inc. achieved positive safety data in its Phase III program for LibiGel (testosterone gel) in development for the treatment of female sexual dysfunction (FSD) and hypoactive sexual desire disorder (HSDD) in menopausal women.

  • Tarsa Completes Phase III Oral Calcitonin Trial

    February 14, 2011
    Tarsa Therapeutics, Inc. has completed its global Phase III ORACAL trial with once-daily oral recombinant calcitonin for the treatment of postmenopausal osteoporosis.

  • FDA Gives RTF to Gilead NDA

    January 26, 2011
    CMC issues halt HIV combo application

  • Furiex IBS Drug Gets Fast Track by FDA

    January 24, 2011
    MuDelta to get accelerated review

  • Abbott Withdraws MAA for Ozespa

    January 17, 2011
    Abbott Laboratories has withdrawn its centralized marketing authorization application with Europe’s EMA for Ozespa, briakinumab, 100 mg solution for injection, for the treatment of moderate to severe chronic plaque psoriasis in adults who failed to