BIA

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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AG Mednet licenses Columbia University software to reduce protocol amendments, unnecessary costs

Monday, November 12, 2012 09:00 AM

Unnecessary procedures and amendments to clinical trial protocols cost sponsors more than $5 billion per year and are responsible for 20% of clinical trial budgets, according to recent research. To help reduce these costs and create zero-delay clinical trials, AG Mednet has licensed from Columbia University advanced image analysis technology developed by Drs. Lawrence Schwartz, Binsheng Zhao and Yongqiang Tan at Columbia University Medical Center.

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Zenobia partners with Alzheimer's Drug Discovery Foundation

Wednesday, August 15, 2012 11:54 AM

Zenobia Therapeutics, a fragment-based discovery company focused on central nervous system (CNS) disease based in San Diego, has formed a strategic partnership to provide Alzheimer's Drug Discovery Foundation (ADDF) researchers access to Zenobia's discovery platform.

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Columbia, Weill Cornell join national effort to spur clinical trials in neurosciences

Friday, March 16, 2012 11:49 AM

The National Institute for Neurological Disorders and Stroke (NINDS) has selected Columbia University College of Physicians and Surgeons and Weill Cornell Medical College to participate in a new national effort to accelerate the development of therapies for people with neurological diseases.

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FDA committee fails to recommend gel to reduce preterm birth

Monday, January 23, 2012 01:55 PM

The FDA’s advisory committee for Reproductive Health Drugs did not recommend approval of progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length at the mid-trimester of pregnancy, confirmed Columbia Laboratories and Watson Pharmaceuticals.

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Results of OncoGenex phase I/II Custirsen trial published

Friday, January 6, 2012 09:32 AM

OncoGenex Pharmaceuticals has reported results of a phase I/II study to determine the effectiveness of its investigational compound custirsen in conjunction with a gemcitabine/platinum-based regimen in patients with advanced non-small cell lung cancer (NSCLC).

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Alexion to acquire Enobia Pharma for $610 million

Tuesday, January 3, 2012 01:39 PM

Alexion Pharmaceuticals and Enobia Pharma have signed a definitive agreement under which Alexion will acquire 100% of the capital stock of Enobia. Enobia is a private biopharmaceutical company based in Montreal, Canada and Cambridge, Massachusetts, which is focused on the development of therapies to treat patients with ultra-rare and life-threatening genetic metabolic disorders.

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FDA, ABIA collaborate on safety and performance of materials in medical devices

Thursday, December 22, 2011 11:05 AM
Austen BioInnovation Institute in Akron (ABIA) and the FDA have entered into a collaboration to support and develop regulatory science for the safe and effective use of biomaterials in medical devices.

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CHIN to accelerate development of new vaccines and therapies

Thursday, December 15, 2011 09:05 AM

Seven universities, led by The University of Western Ontario, have been awarded a $600,000 catalyst grant from the Canadian Institutes of Health Research (CIHR) to create a national network to promote and enhance research on the body’s immune system. 

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Akebia receives $22 million in Series B

Tuesday, April 26, 2011 01:54 PM

Ohio-based Akebia Therapeutics, a pharmaceutical discovery and development company focused on anemia and vascular disorders, has closed a $22 million Series B Preferred stock financing. The round was led by the company's existing investors: Novartis Venture Fund and Venture Investors, Triathlon Medical Ventures, Kearny Venture Partners, Athenian Venture Partners, Sigvion Capital as well as new investors.

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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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