United States

Cantab Connect launches cognitive safety assessment products for tablets

Monday, June 9, 2014 02:00 PM

Cambridge Cognition has launched its first two iPad-tablet products on its new cloud computing Cantab Connect platform for use in clinical trials. Current practice still relies largely on pen and paper questionnaires with widespread potential for inaccuracies.

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WIRB Copernicus Group

BioDelivery Sciences receives FDA approval for BUNAVAIL for opioid dependence

Monday, June 9, 2014 10:24 AM

BioDelivery Sciences International has received approval of the NDA for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) from the FDA. BUNAVAIL is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. BDSI expects to launch BUNAVAIL late in the third quarter of 2014.

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Techorizon to launch TH-eClinical suite at DIA

Thursday, June 5, 2014 11:00 AM

Techorizon, a provider of clinical technology solutions, will launch the TH-eClinical suite of clinical research products June 17 at the DIA Annual Meeting in San Diego.

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FDA launches openFDA to provide easier access to FDA public health datasets

Monday, June 2, 2014 01:19 PM

The FDA has launched openFDA, a new initiative designed to make it easier for web developers, researchers and the public to access large, important public health datasets collected by the agency.

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Sangamo BioSciences, City of Hope granted $5.6M from CIRM

Friday, May 30, 2014 01:36 PM

The California Institute for Regenerative Medicine (CIRM) has granted a $5.6 million Strategic Partnership Award to fund clinical studies at City of Hope to develop a potentially curative ZFP therapeutic for HIV/AIDS based on the application of SangamoBioSciences' zinc finger nuclease (ZFN) genome-editing technology in hematopoietic stem/progenitor cells (HSPCs).

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Trimel receives FDA approval for Natesto Nasal Gel male low testosterone

Friday, May 30, 2014 01:33 PM

The FDA has approved Trimel Pharmaceuticals’ Natesto (testosterone), formerly CompleoTRT, a testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Natesto is self-administered via a nasal applicator, thereby minimizing the risk of secondary exposure to testosterone of women or children.

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FDA approves ALOXI for pediatric, chemotherapy-induced nausea

Thursday, May 29, 2014 01:50 PM

Eisai and Helsinn Group have announced the FDA approval of ALOXI (palonosetron HCl) injection for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in children aged one month to less than 17 years.

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Cancer Treatment Centers of America names Maurie Markman president

Thursday, May 29, 2014 01:39 PM

Cancer Treatment Centers of America (CTCA), a national network of five hospitals that specialize in the treatment of patients fighting complex or advanced-stage cancer, has appointed Maurie Markman, M.D., president of the company's Medicine & Science unit, where he will be responsible for advancing the organization's overall commitment to clinical excellence, innovation, safety and patient satisfaction. Markman was senior vice president of Clinical Affairs and national director of Medical Oncology at CTCA.

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NIA/NIH grants $1.4M to Cognition Therapeutics' Alzheimer's program

Friday, May 23, 2014 02:35 PM

Cognition Therapeutics, an innovative research and drug discovery organization focused on the development of novel disease-modifying therapeutics for neurodegenerative diseases, has announced that its small molecule soluble Abeta receptor antagonist program for the treatment of Alzheimer's disease (AD) has been selected for funding by the National Institute on Aging (NIA)/NIH Alzheimer's Disease Drug Development Program. This cooperative agreement program for Alzheimer's disease translational research will provide Cognition Therapeutics with an estimated $1.4M in funding over four years to support critical drug development activities aimed at securing IND status for the company's first-in-class therapeutics.

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Jack Modell joins Rho as senior medical officer

Thursday, May 22, 2014 11:15 AM

Rho, a privately held CRO located in Chapel Hill, N.C., has announced that Dr. Jack Modell joined its team as senior medical officer, bringing 20 years of experience in clinical research, teaching and patient care in academic medicine, and an additional 10 years of experience in clinical drug development (phase II-IV), medical affairs, medical governance, drug safety and management within the pharmaceutical industry. 

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August 18

Ebola outbreak highlights need to improve biosafety, infrastructure to handle future health emergencies

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Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

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Benefits outweigh the complexities, challenges of finding right vendors

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IRB market consolidating rapidly
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Lessons learned from medical device trials
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