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Biotronik announces first enrollments in new thromboembolic events study

Friday, January 16, 2015 01:03 PM

Biotronik, a manufacturer of cardiovascular medical technology, has announced the first enrollments in its prospective, multi-center, international Reduce-TE Pilot study (Reduction of AF Ablation Induced Thrombo-Embolic Incidence). The study will assess the ability of the advanced irrigated ablation catheter AlCath Flux eXtra Gold to reduce the incidence of silent microemboli (SME). SME are a complication associated with catheter ablation of the pulmonary veins, a common treatment for atrial fibrillation (AF). The Biotronik ablation catheter features a GoldTip and a 3-D irrigation system which study investigators believe can diminish the number of SME via optimized cooling, thereby improving patient safety.

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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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Nobel Laureate Bruce Beutler joins Prevacus medical advisory board

Friday, January 16, 2015 12:45 PM

Prevacus, a biopharmaceutical company based in Tallahassee, Fla., has appointed Nobel Laureate Bruce Beutler to its medical advisory board.

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AC Immune, Janssen to collaborate on Alzheimer's disease vaccines

Friday, January 16, 2015 12:29 PM

AC Immune, a Swiss-based biopharmaceutical company, has entered into a worldwide exclusive license agreement and research collaboration with Janssen Pharmaceuticals to develop and commercialize therapeutic anti-Tau vaccines for the treatment of Alzheimer's disease and potentially other tauopathies.

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Report: Innovation driving positive outlook for pharma and biotech in 2015

Friday, January 16, 2015 12:28 PM

Innovation will continue to drive the pharma and biotech sectors in 2015 as forecasts point to another prosperous year, according to EP Vantage’s latest report, Pharma & Biotech 2015 Preview. EP Vantage is the editorial arm of global market intelligence firm Evaluate.

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WCCT Global, NIAID to collaborate on influenza challenge research

Friday, January 16, 2015 12:26 PM

CRO WCCT Global, headquartered in Southern California, is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) for influenza challenge research. With the construction of WCCT Global's influenza challenge facility in Costa Mesa, Calif., the CRO has the capability to conduct virus challenge clinical trials in North America.

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MRIGlobal awarded $54M by NIH

Friday, January 16, 2015 12:25 PM

MRIGlobal, an independent, nonprofit CRO based in Kansas City, Mo., has been awarded a $54 million, 10-year program from the National Institute of Neurological Disorders and Stroke to provide support for the development and manufacturing of drug candidates for ultimate use in human clinical trials.

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AMRI announces CFO transition

Friday, January 16, 2015 10:50 AM

Michael M. Nolan, senior vice president and chief financial officer, will be departing Albany Molecular Research (AMRI), a global contract research and manufacturing organization. Nolan will remain with AMRI through February 2015 to support an orderly transition. Felicia Ladin will join the company in the same role, effective Feb. 4, 2015.

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Neurotrope forms Clinical Advisory Board to support Alzheimer's disease program

Friday, January 16, 2015 10:43 AM

Neurotrope has formed its Alzheimer's Disease Clinical Advisory Board (CAB) with the following appointments: Jeffery L. Cummings, M.D., ScD, CCF; Martin R. Farlow, M.D.; Sam Gandy, M.D., Ph.D.; Christina Sampaio, M.D., Ph.D.; and Michael Weiner, M.D.

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Astellas Pharma hires global executive Eric Terhaerdt

Friday, January 16, 2015 10:11 AM

Eric Terhaerdt has been named senior vice president of Global Development Operations for Astellas Pharma, based in Tokyo, Japan. Terhaerdt will be located at Astellas' headquarters for the Americas in Northbrook, Ill., and will report to Dr. Bernie Zeiher, executive vice president, Global Development and Therapeutic Area head: immunology, infectious disease, transplantation and central nervous system and pain, with Astellas Pharma Global Development.

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CenterWatch Drugs in Clinical Trials
CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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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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The CenterWatch Monthly

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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