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AstraZeneca, Mitsubishi Tanabe Pharma collaborate on diabetic nephropathy

Thursday, August 21, 2014 01:45 PM

AstraZeneca and Mitsubishi Tanabe Pharma Corporation (MTPC), a research-driven pharmaceutical company based in Japan, have announced a three-year research collaboration in diabetic nephropathy. The aim is to leverage complementary strengths, expertise and assets to validate and progress novel research targets and molecules into clinical development.

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WIRB Copernicus Group

Bristol-Myers Squibb, Celgene collaborate on combination regimen

Thursday, August 21, 2014 01:44 PM

Bristol-Myers Squibb and Celgene have established a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of BMS’ investigational PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), and Celgene’s nab technology-based chemotherapy Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), in a phase I study.

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Illumina partners with AstraZeneca, Janssen, Sanofi for oncology

Thursday, August 21, 2014 01:42 PM

Illumina, a California-based developer, manufacturer and marketer of life science tools and integrated systems for the analysis of genetic variation and function, has formed collaborative partnerships with AstraZenecaJanssen Biotech and Sanofi to develop a universal next-generation sequencing (NGS)-based oncology test system.

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FDA advisory committee recommends approval of Tiotropium Respimat COPD

Thursday, August 21, 2014 10:31 AM

The FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted (10 yes, three no) t/news-online/company/Boehringer+Ingelheimhat existing data supports approval of Boehringer Ingelheim's investigational tiotropium bromide inhalation spray for long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. If approved by the FDA, the proposed proprietary name for tiotropium bromide inhalation spray will be Spiriva Respimat.

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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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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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August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

Sponsors look to the power of genomic profiling to screen, enroll patients in trials for targeted therapies

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August

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

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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