Clinical Intelligence

Three studies show positive results in overactive bladder

Friday, March 2, 2012 06:06 AM

Astellas Pharma Europe, subsidiary of Tokyo-based Astellas Pharma, has reported results from three separate clinical trials that further support the efficacy and tolerability of mirabegron for overactive bladder (OAB).

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Nektar releases positive proof-of-concept data for opioid molecule NKTR-181

Thursday, March 1, 2012 06:02 AM

Nektar Therapeutics has reported positive clinical data for NKTR-181, its new oral opioid analgesic molecule.

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Oncolytics Biotech launches phase II study in prostate cancer

Tuesday, February 28, 2012 06:08 AM

Calgary, Cananda-based Oncolytics Biotech has collaborated with the NCIC Clinical Trials Group (CTG) at Queen's University in Kingston, Ontario, to conduct a randomized phase II study of Reolysin in patients with recurrent or metastatic castration resistant prostate cancer.

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First vaccine for fatal visceral leishmaniasis enters clinical trial

Monday, February 27, 2012 10:08 AM

Seattle-based nonprofit Infectious Disease Research Institute (IDRI) has teamed up with India-based Gennova Biopharmaceuticals to target visceral leishmaniasis (VL), launching a phase I trial of vaccine for the infection disease.

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FDA approves first drug-eluting coronary stents

Monday, February 27, 2012 10:06 AM

The FDA has approved Boston Scientific’s Ion Paclitaxel-Eluting Platinum Chromium Coronary Stent System and Taxus Liberte Paclitaxel-Eluting Coronary Stent System for use in patients experiencing an acute myocardial infarction (AMI), or heart attack. 

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Onyx completes enrollment for phase III trial

Monday, February 27, 2012 10:04 AM

San Francisco, Calif.-based Onyx Pharmaceuticals has reached the target enrollment in the ASPIRE trial, a phase III international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid) and low-dose dexamethasone in patients with relapsed multiple myeloma. 

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FDA advisory committee recommends Qnexa for approval

Monday, February 27, 2012 10:03 AM

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has recommended Vivus’ adult obesity drug Qnexa be granted marketing approval by the FDA.

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Verinata study published in Obstetrics & Gynecology journal

Monday, February 27, 2012 10:01 AM

Obstetrics & Gynecology (Green journal) published full data from Verinata Health’s prospective, blinded, multi-center clinical validation study to detect fetal chromosomal aneuploidies across the entire genome using its verifi prenatal test.

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UCB begins C-EARLY study for rheumatoid arthiritis

Monday, February 27, 2012 03:59 AM

Brussels-based UCB has initiated C-EARLY, a phase III study to evaluate the efficacy and safety of Cimzia (certolizumab pegol) in combination with methotrexate (MTX) for inducing and sustaining clinical response in adults with rheumatoid arthritis (RA) not previously treated with disease-modifying antirheumatic drugs (DMARDs).

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FDA approves first-ever med for Cushing’s syndrome

Friday, February 24, 2012 11:14 AM

The FDA has approved Korlym (mifepristone) 300mg tablets as a once-daily oral medicine to control hyperglycemia secondary to hypercorisolism in adults with endogenous Cushing’s syndrome, according to Corcept Therapeutics.

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CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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