Clinical Intelligence

Sophiris' transrectal injection of PRX302 for enlarged prostate well tolerated

Monday, September 3, 2012 08:16 AM

Sophiris Bio, a urology company based in La Jolla, Calif., released data from its transrectal safety study, in which PRX302, the company's drug candidate for the treatment of benign prostatic hyperplasia (BPH or enlarged prostate), was well tolerated through three months following a transrectal injection.

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Bayer submits NDA for regorafenib for gastrointestinal stromal tumors

Friday, August 31, 2012 12:02 PM

Bayer HealthCare and Onyx Pharmaceuticals, a global biopharmaceutical company based in San Francisco, have submitted a New Drug Application (NDA) to the FDA for the oral multi-kinase inhibitor regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite prior treatment.

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Arrowhead completes enrollment in phase 1b trial of CALAA-01 in solid tumors

Friday, August 31, 2012 09:48 AM

Through its Calando Pharmaceuticals subsidiary, Arrowhead Research, a clinical stage targeted therapeutics company based in Pasadena, Calif., has completed enrollment of a phase 1b clinical trial of CALAA-01, its RNAi therapeutic candidate targeting solid tumors.

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Sosei, Novartis tout positive results for phase III QVA149 study in COPD

Thursday, August 30, 2012 03:19 PM

Novartis and Sosei Group, an international biopharmaceutical company based in Japan, released results from the fifth QVA149 (indacaterol maleate / glycopyrronium bromide) phase III study, SPARK, which met its primary endpoint of a reduced rate of moderate-to-severe COPD exacerbations compared to glycopyrronium bromide (Seebri Breezhaler).

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FDA approves Gilead's Stribild, four-in-one HIV drug

Wednesday, August 29, 2012 10:19 AM

The FDA has approved Stribild, a complete once-daily single tablet regimen, for the treatment of HIV-1 infection in treatment-naïve adults, according to Gilead Sciences, the Foster City, Calif.-based biopharmaceutical company that developed the drug.

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Northwest Bio gets OK for phase III brain cancer trial in the U.K.

Friday, August 24, 2012 09:00 AM

Northwest Biotherapeutics, a Bethesda, Md.-based biotech, has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) of the U.K. to proceed with the company's 300-patient phase III clinical trial of DCVax-L immune therapy for Glioblastoma multiforme brain cancer (GBM).

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Common antifungal drug decreases tumor growth, shows promise as cancer therapy

Wednesday, August 22, 2012 10:18 AM

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FDA green lights first cord blood stem cell trial in autism

Tuesday, August 21, 2012 11:38 AM

Sutter Neuroscience Institute, a recognized Center of Excellence in Sacramento, Calif., and the Cord Blood Registry (CBR), the world's largest stem cell bank, are launching the first FDA-approved clinical trial to assess the use of a child's own cord blood stem cells to treat select patients with autism. 

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ThromboGenics publishes phase III data of ocriplasmin for VMT

Friday, August 17, 2012 03:11 PM

ThromboGenics, a Belgium-based biopharmaceutical company focused on ophthalmic medicines, has published data from two phase III clinical trials evaluating ocriplasmin for the treatment of Vitreomacular Adhesion (VMA) and macular holes in the New England Journal of Medicine.

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Enzalutamide adds 5 months survival in late-stage prostate cancer

Friday, August 17, 2012 02:52 PM

Results of a phase III clinical trial of the drug Enzalutamide, recently published in the New England Journal of Medicine, show the drug extends life by an average five months in the most advanced stages of prostate cancer.

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