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NIH adds genetic health information to online database

Friday, February 28, 2014 12:07 PM

Researchers now will have access to genetic data linked to medical information on a diverse group of more than 78,000 people, enabling investigations into many diseases and conditions.

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CRF Health eCOA webinar series

CluePoints expands global team

Friday, February 28, 2014 11:36 AM

CluePoints, a provider of Risk-Based Monitoring (RBM) solutions for clinical trials, has announced three new appointments to its global team. John Colby and Elizabeth Polvent join the company's U.S business development team, fulfilling a key element in its strategy for growth, while CluePoints also welcomes Jean Stéphenne, president of the board of directors of GlaxoSmithKline Biologicals, as a member of its board.

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DOD selects Bavarian Nordic's vaccine platform for new vaccine development

Wednesday, February 26, 2014 01:00 PM

Bavarian Nordic’s MVA-BN vaccine platform technology has been selected by the Defense Threat Reduction Agency (DTRA), a part of the U.S. Department of Defense, for development of a vaccine against two potential biological threats to national security—Burkholderia pseudomallei and Burkholderia mallei. Bavarian Nordic is an international biotechnology company developing and manufacturing novel cancer immunotherapies and vaccines for infectious diseases.

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FDA approves Myalept to treat rare metabolic disease

Wednesday, February 26, 2014 11:42 AM

The FDA has approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. 

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FDA approves Northera to treat neurogenic orthostatic hypotension

Wednesday, February 19, 2014 03:53 PM

The FDA has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy and pure autonomic failure.  

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Report: U.S. biopharma companies currently developing 182 diabetes treatments

Wednesday, February 19, 2014 01:24 PM

America’s biopharmaceutical research companies currently are developing 182 innovative new medicines to help the nearly 400 million people who have diabetes worldwide. These medicines in development—all either in clinical trials or under review by the FDA—include 30 for type 1 diabetes, 100 for type 2 and 52 for diabetes-related conditions, according to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA).

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CSG to include FSP staffing for clinical development

Wednesday, February 19, 2014 01:22 PM

CSG, a privately-held provider of contract and direct-hire personnel to the biotech, CRO, pharma, medical device and site management industries, will begin offering FSP solutions, with dedicated teams to support a single client’s pipeline of clinical trials work.

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Report: U.S. Alzheimer's imaging agent market will grow as reimbursement improves

Thursday, February 13, 2014 03:03 PM

The U.S. Alzheimer's imaging agent market will grow dramatically over the next 10 years, according to Decision Resources Group. Currently, Eli Lilly's Amyvid, launched in June 2013, is the only FDA-approved product available, but GE Healthcare, Piramal Enterprises and Navidea Biopharmaceuticalsare all poised to launch products in the U.S. in the next few years.

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NIH grants $1.48M for Massachusetts patient medication adherence study

Wednesday, February 5, 2014 01:21 PM

University of Arizona (UA) associate professor of anthropology Susan J. Shaw and UA assistant professor of pharmacy Jeannie Lee have received $1.48 million from the NIH to study factors that affect medication adherence among residents in Massachusetts, where state law mandates that nearly every resident receive a minimum level of healthcare insurance coverage.

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NIH, industry and nonprofits join forces to speed validation of disease targets

Wednesday, February 5, 2014 01:02 PM

The National Institutes of Health, 10 biopharmaceutical companies and several nonprofit organizations have launched an unprecedented partnership to transform the current model for identifying and validating the most promising biological targets of disease for new diagnostics and drug development.

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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

April

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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The CenterWatch Monthly

March

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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