Clinical Intelligence

FDA grants accelerated approval for Sirturo for multi-drug resistant TB

Wednesday, January 2, 2013 03:13 PM

The FDA has granted accelerated approval to Janssen Therapeutics’ Sirturo (bedaquiline) tablets for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The accelerated approval is based on the surrogate endpoint of time to sputum culture conversion.

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FDA approves Eliquis to reduce blood clots non-valvular atrial fibrillation

Wednesday, January 2, 2013 02:48 PM

The FDA has approved Bristol-Myers Squibb and Pfizer’s anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem.

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The CenterWatch Monthly, January 2013

Wednesday, January 2, 2013 01:39 PM

Parexel celebrates 30 years of change, growth

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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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