Clinical Intelligence

FDA approves GSK's four-strain seasonal influenza vaccine

Monday, December 17, 2012 04:28 PM

The FDA has approved GlaxoSmithKline’s Fluarix Quadrivalent (influenza virus vaccine) for the immunization of adults and children (three years and older) to help prevent disease caused by seasonal influenza virus subtypes A and B contained in the vaccine.

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UMCG initiates enrollment in RENEW trial for severe emphysema

Monday, December 17, 2012 12:31 PM

The University Medical Center Groningen has enrolled and treated the first patients in the FDA-approved RENEW pivotal trial to evaluate the RePneu Lung Volume Reduction Coil (LVRC) in severe emphysema. 

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Bayer submits NDA for radium Ra 223 dichloride for castration-resistant prostate cancer

Friday, December 14, 2012 12:07 PM

Bayer HealthCare has submitted a New Drug Application (NDA) to the FDA seeking approval for radium Ra 223 dichloride (radium-223), a fast tracked investigational compound for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases.

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Lilly discontinues 1 of 3 phase III rheumatoid arthritis registration studies for tabalumab

Friday, December 14, 2012 11:40 AM

Global pharmaceutical company Eli Lilly is halting one of three phase III rheumatoid arthritis (RA) registration studies of tabalumab, an anti-BAFF monoclonal antibody, due to insufficient efficacy.

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Insero Health completes phase I trial in drug resistant epilepsy

Thursday, December 13, 2012 08:00 AM

Insero Health, a clinical-stage company that develops small molecule therapies derived from natural products to treat neurological diseases, has completed a phase Ib trial of its lead compound INS001 in patients with drug-resistant epilepsy. 

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uniQure initiates phase I study in acute intermittent porphyria

Wednesday, December 12, 2012 10:48 AM

uniQure, a company that researches and develops human gene based therapies, has initiated its phase I clinical trial in acute intermittent porphyria (AIP).

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NanoString touts positive results from study of PAM50-based breast cancer assay

Friday, December 7, 2012 03:01 PM

NanoString Technologies, a Seattle, Wash.-based privately held provider of life science tools for translational research and developer of molecular diagnostic products, released positive results from the second clinical validation study of its in vitro diagnostic breast cancer assay based on the PAM50 gene expression signature.

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FDA grants Biodel orphan drug designation for rare insulin disease

Friday, December 7, 2012 02:34 PM

The FDA has given special designation to glucagon, developed by specialty pharmaceutical company Biodel,for patients with congenital hyperinsulinism (CHI), or abnormally low blood sugar—a rare disorder that affects children.

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Emmaus Medical completes enrollment for phase III sickle cell disease trial

Wednesday, December 5, 2012 10:11 AM

Emmaus Medical, a specialty pharmaceutical and regenerative medicine company, has completed patient enrollment for its phase III clinical trial to study L-glutamine as a treatment for sickle cell disease.

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AVEO, Astellas initiate phase II trial in triple negative breast cancer

Monday, December 3, 2012 02:11 PM

AVEO Oncology, a Cambridge, Mass.-based cancer therapeutics company, and Astellas Pharma, A Tokyo-based a pharmaceutical company, have initiated patient enrollment in a phase II trial evaluating the efficacy of tivozanib, an investigational drug, in combination with paclitaxel in patients with locally recurrent or metastatic triple negative breast cancer.

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