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Positive results released for Amgen’s phase III study of AMG 416

Thursday, August 21, 2014 10:24 AM

Amgen has announced that a second placebo-controlled, phase III study evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints.

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WIRB Copernicus Group

Clintrax Global adds Bradford Evans as vice president of administration

Thursday, August 21, 2014 10:14 AM

Clintrax Global, a worldwide provider of clinical research services located in Raleigh, N.C., recently announced the addition of Bradford Evans as vice president of administration. Evans will oversee all corporate processes, including their alignment with company objectives and policies.

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MediciGlobal appoints Linda Capsey vice president

Thursday, August 21, 2014 10:07 AM

MediciGlobal, a global provider of patient recruitment and retention for clinical trials with offices in Pennsylvania and London, has appointed Linda Capsey, Ph.D., vice president project management and innovation. Capsey will provide strategic and operational oversight for recruitment-retention program development, site training workshops for patient communications and informed consent, and work as a consultant to biopharmaceutical companies for patient recruitment-retention planning and feasibility.

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Bedrocan Cannabis appoints three as independent directors

Thursday, August 21, 2014 09:58 AM

Bedrocan Cannabis, previously Bedrocan Canada has appointed three independent members to its board of directors, enhancing executive oversight and strengthening the health care experience of the company, a licensed researcher and producer of medicinal cannabis in Canada.

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Pfizer, Gamida Cell ink investment and option agreement

Wednesday, August 20, 2014 01:31 PM

Gamida Cell, an Israel-based provider of stem cell expansion technologies and therapeutic products, has signed an investment and option agreement with Novartis Pharma. Novartis will invest $35 million in Gamida Cell and in return will receive 15% equity and an option to fully acquire Gamida Cell. The option is exercisable for a limited period of time following achievement of certain milestones connected to the development of NiCord, anticipated to be met during 2015.

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BARDA extends contract with Cytori for thermal burn treatment

Wednesday, August 20, 2014 01:29 PM

Cytori Therapeutics, a California-based developer of cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and other medical conditions, and Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, have announced the execution of a contract option to fund the continued investigation and development of Cytori Cell Therapy for use in thermal burn injuries.

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RTI International develops novel lung-on-a-chip

Wednesday, August 20, 2014 01:27 PM

Researchers at RTI International, a nonprofit organization headquartered in Research Triangle Park, N.C., that provides research and technical services, in collaboration with the University of North Carolina at Chapel Hill, have developed a new lung-on-chip microdevice for laboratory studies of respiratory challenges and therapeutics. The microdevice includes multiple vertically stacked cellular layers that mimic the structure of the airway tissue. 

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Valeant extends offer to acquire Allergan

Wednesday, August 20, 2014 01:26 PM

Valeant Pharmaceuticals International has extended the expiration of its exchange offer to acquire all outstanding shares of Allergan to 5:00 p.m., New York City time, Dec. 31. The exchange offer previously was scheduled to expire at 5:00 p.m., New York City time, Friday, Aug. 15. All other terms and conditions of the exchange offer remain unchanged.

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MMS Holdings, Oncology Trials Insights partner on oncology support services

Wednesday, August 20, 2014 01:24 PM

MMS Holdings, a Mississippi-based global CRO that focuses on regulatory submission support, and Oncology Trials Insights (OTI), a Colorado-based organization of oncology key opinion leaders that architect superior clinical trial strategies and facilitate improved decision-making, have partnered to deliver comprehensive oncology support services.

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Roche, Garvan Institute of Medical Research partner

Wednesday, August 20, 2014 01:22 PM

Roche and the Australia-based Garvan Institute of Medical Research are collaborating to develop new technologies for targeted epigenomic analysis using DNA sequencing. Genomics is a rapidly evolving field with a focus on realizing the potential use of sequencing information in patient diagnosis and treatment.

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