Industry News

Segal Institute takes step to reduce duplicate enrollment in clinical trials

Centerwatch - Thu, 2016-09-22 14:36

Segal Institute for Clinical Research has chosen Verified Clinical Trials (VCT), a global clinical trial database registry utilizing biometric fingerprint technology, to counter attempts at duplicate enrollment in clinical trial research and improve the safety of research volunteers and data quality. Segal Institute for Clinical Research has elected to institute verification of the enrollment status […]

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Alnylam opens new European office in Maidenhead, UK

Centerwatch - Thu, 2016-09-22 14:07

Alnylam Pharmaceuticals, an RNAi therapeutics company, has announced the expansion of its global footprint with the opening of a new development and commercial hub in Maidenhead, U.K. In anticipation of substantial growth across Alnylam over the next five years, the office opens with a core clinical development, regulatory affairs and commercial team and space for […]

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Duke Clinical Research Institute to coordinate national childhood health study

Centerwatch - Thu, 2016-09-22 13:59

The Duke Clinical Research Institute (DCRI) has been named the coordinating center as part of a $157-million federal initiative involved in studying how environmental factors affect childhood health. The seven-year grant from the NIH will fund the organizational framework of the Environmental Influences on Child Health Outcomes (ECHO) initiative. As the coordinating center for the […]

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Newly Added Guidance Documents

FDA News - Thu, 2016-09-22 09:07
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Clinical Investigator Inspection List (CLIIL)

FDA News - Thu, 2016-09-22 08:52
The Clinical Investigator Inspection List contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs.
Categories: Industry News

A Study of LY3314814 in Participants With Mild Alzheimer's Disease Dementia

Alzheimers - Wed, 2016-09-21 20:00
Status: Recruiting, Condition Summary: Alzheimer's Disease
Categories: Industry News

Emma Walmsley to succeed Andrew Witty as CEO of GlaxoSmithKline

Centerwatch - Wed, 2016-09-21 10:34

GSK has announced that Emma Walmsley, currently chief executive officer (CEO) of GSK’s Consumer Healthcare division, has been appointed GSK CEO Designate and will succeed Andrew Witty as GSK CEO when he retires on March 31, 2017. Walmsley will join the GSK board of directors January 2017. Walmsley is currently CEO of GSK Consumer Healthcare, […]

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Bayer, Evotec partner on kidney diseases treatments

Centerwatch - Wed, 2016-09-21 10:30

Bayer and Evotec have entered into a five-year, multi-target research partnership to develop multiple clinical candidates for the treatment of kidney diseases such as chronic kidney disease in diabetes patients. Both companies will contribute novel drug targets and a comprehensive set of high-quality technology platforms to jointly develop innovative treatment options for these severe conditions. […]

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Allergan to acquire Tobira Therapeutics for $1.7B

Centerwatch - Wed, 2016-09-21 10:26

Allergan, a global pharmaceutical company, and Tobira Therapeutics, a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases, have entered into a definitive agreement under which Allergan will acquire Tobira for an upfront payment of $28.35 per share, in cash, and up to $49.84 per share in Contingent Value Rights (CVRs) that may […]

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Zafgen initiates phase I trial of ZGN-1061

Centerwatch - Wed, 2016-09-21 10:19

Zafgen, a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, has announced that the company has recently initiated dosing in the multiple ascending dose (MAD) cohorts of its ongoing phase I clinical trial of ZGN-1061. The initiation of the MAD portion was triggered following a […]

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Pediatric Cancer Foundation to honor Congressmen McCaul & Van Hollen

Centerwatch - Wed, 2016-09-21 10:11

Congressman Michael Mccaul and Congressman Chris Van Hollen to be honored at the 3rd Annual Golden Toast. The Golden Toast represents bipartisan politics at its finest. It is an evening when members of Congress from both sides of the aisle demonstrate a commitment to some of the most vulnerable members of society—children who are fighting […]

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Report: Osteoarthritis space set to approach $10.5B by 2024

Centerwatch - Tue, 2016-09-20 09:24

The osteoarthritis market across the seven major markets of the U.S., France, Germany, Italy, Spain, the U.K., and Japan is forecast to more than treble from $3.25 billion in 2014 to $10.49 billion by 2024, representing a compound annual growth rate of 17.8%, according to research and consulting firm GlobalData. The company’s report states that […]

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Chesapeake IRB hires Randall Hein as senior vice president, Sales and Marketing

Centerwatch - Tue, 2016-09-20 09:21

Chesapeake IRB, a provider of independent institutional review board services for the life science industry, has hired Randall Hein, an executive with more than 20 years of experience in operations, sales and consulting for life science organizations, as its senior vice president, sales and marketing. “Randall brings a wealth of experience in clinical development and […]

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GSK’s candidate shingles vaccine shows high efficacy against shingles

Centerwatch - Tue, 2016-09-20 09:16

GSK has announced the publication of detailed results from a randomized phase III study (ZOE-70) of its investigational shingles vaccine, Shingrix, showing 90% efficacy in adults aged 70 years and older that is maintained for at least four years. The results were published in the New England Journal of Medicine (NEJM). The study, from which […]

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Teva, Intel to develop Huntington wearable tech and machine learning platform

Centerwatch - Tue, 2016-09-20 08:23

Teva Pharmaceutical Industries has announced a collaboration with Intel to develop a unique wearable device and machine learning platform for use in Huntington disease (HD). This platform will continuously monitor and analyze key symptoms that impact daily living, in an effort to better understand disease progression and improve treatment evaluation. Teva, working in collaboration with […]

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HHS provides more information about clinical trials to the public

Centerwatch - Tue, 2016-09-20 08:17

In an effort to make information about clinical trials widely available to the public, the HHS has issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving FDA-regulated drug, biological and […]

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Bracket randomizes first patient using integrated precision block technology

Centerwatch - Tue, 2016-09-20 08:14

Bracket, a clinical trial technology and specialty services provider, has randomized its first patient using Precision Block Design (PBD) technology integrated in its clinical IRT platform, including its mobile application. The first RTSM provider to develop and utilize the novel PBD method, Bracket is minimizing selection bias, reducing predictability of treatments and improving patient randomization […]

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Premier Biomedical, ATS form Premier Biomedical Pain Management Solutions

Centerwatch - Tue, 2016-09-20 08:12

Premier Biomedical has announced the signing of an agreement forming a joint venture company with Advanced Technologies Solutions (ATS), a San Diego, California enterprise. The joint venture company, Premier Biomedical Pain Management Solutions, will develop and market natural and cannabis-based generalized, neuropathic, and localized pain relief treatment products. Sales for the initial product, an extended-duration topical […]

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Eisai establishes AiM Institute for precision medicines

Centerwatch - Tue, 2016-09-20 07:59

Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., has announced the launch of the Eisai Andover innovative Medicines (AiM) Institute, a discovery innovation unit within the greater Boston biopharma hub. With 90 integrated scientists at a state-of-the-art research facility in Andover, Massachusetts, the Institute is focused on executing novel therapeutic targets validated by human genetics and […]

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EMD Serono appoints Craig Millian SVP, Neurology And Immunology

Centerwatch - Tue, 2016-09-20 07:55

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada, has announced the appointment of Craig Millian as senior vice president, Neurology and Immunology. Millian most recently served as senior vice president, head of U.S. Fertility and Endocrinology at EMD Serono. In his new role, he will lead the strategic direction of the company’s […]

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