United States

FDA approves VBLOC vagal blocking therapy for obesity

Friday, January 16, 2015 12:52 PM

The FDA has approved medical device company EnteroMedics’ VBLOC vagal blocking therapy, delivered via the Maestro System, for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years.

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35 partners from industry and academia collaborate on European research initiative

Thursday, January 15, 2015 01:40 PM

The European Prevention of Alzheimer's Dementia (EPAD) initiative has begun a novel collaboration between academic and private sectors to test innovative treatments for the prevention of Alzheimer’s dementia.

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Crohn's & Colitis Foundation of America, ResearchMatch partner

Wednesday, January 14, 2015 12:32 PM

ResearchMatch, a U.S.-wide, disease-neutral, volunteer research recruitment and engagement platform, is partnering with the Crohn's & Colitis Foundation of America (CCFA), a volunteer-driven organization dedicated to curing Crohn's disease and ulcerative colitis, and improving the quality of life of children and adults affected by those diseases.

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goBalto releases latest update of goBalto Activate

Wednesday, January 14, 2015 12:32 PM

goBalto, a San Francisco, Calif.-based provider of cloud-based clinical study startup solutions, has released its latest version of goBalto Activate, its flagship study startup platform.

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Novella Clinical, Cardiovascular Research Foundation collaborate, provide clinical trial expertise

Monday, January 12, 2015 02:37 PM

Novella Clinical, a Quintiles company, and the Cardiovascular Research Foundation (CRF), an independent, academically focused nonprofit organization based in New York, have announced a preferred provider collaboration that will offer a set of clinical trial services to developers of cardiovascular drugs and devices.

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MedNet Solutions updates iMedNet eClinical

Friday, January 9, 2015 02:03 PM

MedNet Solutions, a Minnetonka, Minn.-based global life sciences technology company specializing in clinical study management systems, has updated iMedNet eClinical, its innovative, cloud-based technology platform. iMedNet said its software-as-a-service (SaaS) solution is intuitive, flexible and affordable for sponsors and CROs wishing to quickly and efficiently build studies themselves.

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Inovio Pharmaceuticals HIV immunotherapy shows vital characteristics

Thursday, January 8, 2015 02:28 PM

Inovio Pharmaceuticals has reported results from a 12-patient, phase I study of Inovio's HIV immunotherapy, PENNVAX-B, in HIV-infected patients revealed that immune response characteristics generated by the immunotherapy were similar to those observed in HIV-infected individuals who without treatment do not progress to further stages of the disease.

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FDA grants Soligenix Fast Track designation for SGX301 for lymphoma

Thursday, January 8, 2015 02:12 PM

Soligenix, a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, has announced that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received Fast Track designation from the FDA.

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American Diabetes Association announces new national officers and board members

Thursday, January 8, 2015 01:54 PM

The American Diabetes Association, a voluntary health organization leading the fight to Stop Diabetes, has announced its officers and board of directors members for 2015.

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Carl Feldbaum joins Trovagene's board of directors

Thursday, January 8, 2015 01:17 PM

Trovagene, a developer of cell-free molecular diagnostics, has announced that Carl Feldbaum, president emeritus of the Biotechnology Industry Organization (BIO), a biotechnology trade association, has been appointed to its board of directors. He also will be chairman of the company's Corporate Governance and Nominating committee.

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CWWeekly

January 19

Roche takes $1B majority stake in Foundation Medicine to use genomic testing to personalize oncology treatments

BRANY launches software, iPad app to streamline protocol creation for investigator-initiated trials

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The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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