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ActiGraph launches GT9X Link activity monitor

Friday, November 14, 2014 10:47 AM

ActiGraph, a Pensacola, Fla.-based provider of objective physical activity and sleep/wake measurement solutions for the global research community and pharmaceutical industry, has released the ActiGraph GT9X Link activity monitor. The redesigned ActiGraph Link expands upon the company’s scientifically validated physical activity and sleep measurement platform with a rich feature set that delivers an improved subject experience along with multiple new channels of sensor data captured by a gyroscope, magnetometer and secondary accelerometer.

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U.K. university, hospital, pharmacy collaborate to improve medicines management

Friday, November 14, 2014 10:45 AM

The first research collaboration in the U.K. among a hospital, university and community pharmacist is taking place through a project from Liverpool John Moores University (LJMU), the Royal Liverpool and Broadgreen University Hospitals NHS Trust and LloydsPharmacy. The collaboration aims to improve the way patients use their medicines outside hospitals and will be carried out in the newly opened Center for Pharmacy Innovation at the LJMU School of Pharmacy and Biomolecular Sciences.

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GHIT Fund calls for greater collaboration on infectious diseases

Friday, November 14, 2014 10:43 AM

The Global Health Innovative Technology (GHIT) Fund and the Embassy of Japan have called for greater cross-border collaboration to ensure global preparedness for the inevitable resurgence of infectious diseases, including tuberculosis, malaria, HIV/AIDS and neglected tropical diseases.

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ArQule, NIH collaborate to develop ARQ 092 in Proteus syndrome

Friday, November 14, 2014 10:39 AM

ArQule, a Woburn, Mass.-based biotech company engaged in the R&D of next-generation, small-molecule cancer therapeutics, has formed an agreement with the National Human Genome Research Institute (NHGRI) of the NIH, providing for the clinical development of ARQ 092, an orally available, selective small molecule inhibitor of AKT, in Proteus syndrome, a rare disease characterized by overgrowth of the skeleton, skin, adipose tissue and central nervous system.

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PRA Health Sciences becomes latest big CRO to launch IPO

Thursday, November 13, 2014 03:38 PM

PRA Health Sciences launched its initial public offering this morning, raising $306 million from the sale of nearly 17 million shares at $18 per share—below plans it announced in September to raise up to $375 million.

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FDA accepts Actavis’ sNDA for Saphris for bipolar I disorder in pediatric patients

Thursday, November 13, 2014 02:35 PM

The FDA has accepted for filing Actavis' supplemental New Drug Application (sNDA) for Saphris (asenapine) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients 10 to 17 years of age. Actavis' sNDA for Saphris has been granted priority review status by the FDA.

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Cell Source's Megadose Drug Combination to begin human trials in Italy

Thursday, November 13, 2014 02:31 PM

Cell Source, an immunotherapy and regenerative medicine company, has announced its Megadose Drug Combination has been cleared for human clinical trials in Italy. Cell Source's proprietary Megadose Drug Combination is expected to increase bone marrow transplantation (BMT) success and survival.

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FDA approves sNDAs for Invega Sustenna for schizoaffective disorder

Thursday, November 13, 2014 02:22 PM

The FDA has approved Janssen Pharmaceutical's supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy. The symptoms of schizoaffective disorder are complex and, without treatment, disabling. The FDA approved these sNDAs under Priority Review, which is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.

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Edward Lanphier elected chairman of the Alliance for Regenerative Medicine

Thursday, November 13, 2014 02:15 PM

Sangamo BioSciences has announced that Edward Lanphier, the company's president and CEO, has been elected as the next chairman of the Alliance for Regenerative Medicine (ARM). Wash. D.C.-based ARM is an international organization that represents and supports industry, clinical institutions, patient advocates and other stakeholders in the development of safe and effective gene and cell therapies. Lanphier succeeds Geoff MacKay, president and CEO of Organogenesis, who will complete his two-year term as chairman on Dec. 31.

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inVentiv Health names Jeffrey Wilks president of advertising

Thursday, November 13, 2014 02:10 PM

inVentiv Health, a life science knowledge and services company for the new healthcare environment, has appointed of Jeffrey Wilks as president of its advertising businesses. Wilks will report to Mike Griffith, executive vice president, inVentiv Health and president, inVentiv Commercial.

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November 17

PPD, Medidata join their technologies for risk-based monitoring, adaptive trial design

ERT acquires eClinical Insights in "strategic combination" to gain cloud-based trial software platform, expertise

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November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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