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United States

FDA approves Hetlioz for sleep-wake disorder in blind individuals

Monday, February 3, 2014 10:38 AM

The FDA approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (non-24) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for the disorder.

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CRF Health eCOA webinar series

Midwest healthcare companies raise $758 million in 2013

Wednesday, January 29, 2014 12:55 PM

Midwest healthcare companies attracted $758 million in new investments across 217 companies in 2013, according to the BioEnterprise Midwest Healthcare Venture Investment Report. As with the nationwide trend, Midwest investment decreased from 2012. Ohio ($296 million) and Minnesota ($228 million) led Midwestern states in attracting investment dollars.

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ERT receives Philadelphia SmartCEO’s Future 50 Award

Monday, January 27, 2014 02:19 PM

ERT, a global solution provider for high-quality patient safety and efficacy endpoint data collection, has announced that Philadelphia SmartCEO has recognized the company in its Future 50 Awards program. The program recognizes the region’s fastest-growing mid-sized and large Blue Chip companies that have experienced outsized growth based on a combined three-year average of revenue and employee growth. 

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FDA launches advisory committee membership nomination portal

Wednesday, January 22, 2014 12:56 PM

The FDA has launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees. 

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Award to honor Woman of the Year

Tuesday, January 21, 2014 11:13 AM

IIR Partnerships has launched a new award program to honor a Woman of the Year, to be presented in conjunction with the 3rd Annual Women’s Clinical Leadership Forum, Monday, March 31, at the 22nd Annual Partnerships in Clinical Trials conference in Las Vegas.

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Crealta Pharmaceuticals acquires Savient Pharmaceuticals

Tuesday, January 14, 2014 10:00 AM

Crealta Pharmaceuticals, a new specialty pharmaceutical company, has acquired substantially all of the assets of Savient Pharmaceuticals. Crealta previously announced winning an auction for these assets, signing a definitive acquisition agreement with Savient and the subsequent approval of the transaction by the U.S. Bankruptcy Court for the District of Delaware.

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Trovagene, U.S. Oncology Research collaborate on metastatic pancreatic cancer

Monday, January 6, 2014 11:56 AM

Trovagene, a San Diego, Calif.-based developer of cell-free molecular diagnostics, and U.S. Oncology Research, a community-based research program in the U.S., have entered into a Clinical Study Agreement to examine the utility of quantitative urine-based KRAS mutation detection and monitoring in pancreatic cancer patients.

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TauRx expands Alzheimer's clinical trials in the U.S.

Monday, January 6, 2014 11:55 AM

TauRx Therapeutics, a clinical-stage biopharmaceutical company developing a novel treatment for Alzheimer's disease, has expanded its international clinical trials by adding new research centers across the U.S. The addition of 35 clinical research centers means more patients suffering from mild or moderate Alzheimer's, and their caregivers, will have an opportunity to see if they qualify for participation in TauRx's Alzheimer's clinical trials.

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Cyprotex acquires CeeTox

Thursday, January 2, 2014 10:34 AM

Cyprotex, a specialist ADME-Tox CRO, has acquired CeeTox, a division of North American Science Associates. CeeTox, based in Kalamazoo, Mich., is a CRO specializing in the provision of in vitro toxicological assays and screening data, principally to the Cosmetic and Personal Care Industries. Founded in 2003, CeeTox was acquired in 2005 by NAMSA, a medical research organization supplying expert consulting, clinical and laboratory services to medical device, IVD and biologics manufacturers. NAMSA retains a license for applying CeeTox’s in vitro toxicology experience to medical device testing.

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NIH to fund research workforce diversity program

Thursday, January 2, 2014 10:25 AM

The National Institutes of Health (NIH) is releasing three new funding opportunity announcements (FOAs) to develop approaches to engage researchers, especially from backgrounds underrepresented in biomedical sciences, and prepare them to thrive in NIH-funded research careers.

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April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly


Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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