Clinical Intelligence

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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The CenterWatch Monthly, December 2012

Monday, December 3, 2012 09:00 AM

Publicity, regulation tightening reins on use of KOLs

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Boston Scientific enrolls first patient in coronary stent study featuring bioabsorbable polymer coating

Friday, November 30, 2012 12:13 PM

The first patient has been enrolled in Boston Scientific’s EVOLVE II clinical trial, designed to further assess the safety and effectiveness of the SYNERGY Stent System and support FDA and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.  

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February 25

Analysts: With market anticipation of Quintiles IPO, other CROs could soon file to go public

National Clinical Trial Network aims to link sponsors, minority patients for trials and access to new therapies

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The CenterWatch Monthly

March

Sites rate the best
sponsors of 2013

Largest survey response ever puts Biogen Idec, Forest Labs, Bayer at top

As CRO industry
turns 30, a look back
at modest beginnings

Phenomenal growth, strategic partnering highlight evolution
of CROs

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The CenterWatch Monthly

February

Sized out of big deals,
mid-tier CROs still thriving

Finding market niches, strategies to stay vital in changing research enterprise

Industry leaders embrace disruptive innovations
Despite resistance to change, many exploring data sharing, open-source collaboration

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