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Celerion joins Cardiac Safety Research Consortium

Thursday, October 16, 2014 07:00 AM

Celerion, a Lincoln, Neb.-based provider of cardiovascular safety services in early clinical research, has become a member of the Cardiac Safety Research Consortium (CSRC). Celerion will engage with other thought leaders on key issues that impact cardiovascular safety, including discussions of alternative approaches to ICH E14 to assess arrhythmia liability in early drug development.

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CCRM, RepliCel to partner on development of cell therapies for tendon repair

Thursday, October 16, 2014 06:30 AM

RepliCel Life Sciences, a Vancouver-based clinical stage regenerative medicine company focused on the development of autologous cell therapies, is the newest member of the Center for Commercialization of Regenerative Medicine’s (CCRM) industry consortium, a Canadian not-for-profit organization.

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KCR launches KCR Date Forecaster app for medical appointment scheduling

Wednesday, October 15, 2014 09:00 PM

KCR, a European CRO, has launched KCR Date Forecaster, a mobile application providing patients with smart scheduling and automatic reminders for doctor appointments and medical examinations. 

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Bristol-Myers Squibb, Pharmacyclics and Janssen collaborate

Wednesday, October 15, 2014 08:00 PM

Bristol-Myers SquibbPharmacyclics and Janssen R&D have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of BMS’ investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in combination with Imbruvica (ibrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor co-developed and co-marketed by Pharmacyclics and Janssen.

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Alexion, Cincinnati Children’s launch rare disease innovation fund

Wednesday, October 15, 2014 06:30 PM

Alexion Pharmaceuticals, a Cambridge, Mass.-based developer of breakthrough therapies for patients with severe and life-threatening rare diseases, and Cincinnati Children’s Hospital Medical Center have established the Alexion Rare Disease Innovation Fund for the advancement of research in rare disease.

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Impax to acquire Tower Holdings and Lineage Therapeutics

Wednesday, October 15, 2014 06:00 PM

Hayward, Calif.-based Impax Laboratories will acquire Tower Holdings, including operating subsidiaries CorePharma, based in Middlesex, N.J., Amedra Pharmaceuticals, based in Horsham, Penn., and Lineage Therapeutics, also based in Horsham, for $700 million in cash, subject to certain customary purchase price adjustments.

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Aastrom Biosciences to change name to Vericel, move headquarters to Massachusetts

Wednesday, October 15, 2014 05:30 PM

Aastrom Biosciences, a developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, plans to change its corporate name to Vericel and move its corporate headquarters from Ann Arbor, Mich., to Cambridge, Mass. The corporate name change is subject to the approval of Aastrom's shareholders. Aastrom will continue to maintain manufacturing facilities in Cambridge and Ann Arbor.

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Clinical Conductor CTMS launches oncology updates

Wednesday, October 15, 2014 01:45 PM

Clinical Conductor, created by Rochester, N.Y.-based Bio-Optronics, a provider of software and services to healthcare and life sciences organizations, has launched new enhancements to the Clinical Conductor CTMS. This oncology-focused release is the first of several and adds advanced features and functionalities designed to optimize the management and execution of oncology studies at organizations of all sizes and makeups.

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Medidata updates Medidata Clinical Cloud

Wednesday, October 15, 2014 01:40 PM

Medidata, a New York-based global provider of cloud-based solutions for clinical research, has announced the latest release of the Medidata Clinical Cloud and the immediate availability of new capabilities and enhancements that broaden the company’s platform of advanced technologies and data analytics. The new features are designed to optimize clinical trial processes and enhance sponsor-site relationships.

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NICE develops new guidelines for antibiotic resistance

Wednesday, October 15, 2014 01:39 PM

NICE is developing two new guidelines to help tackle the growing threat of antibiotic resistance. The first is on safe and effective antimicrobial stewardship in relation to the use of antimicrobials in health and social care, and the second is a public health guideline that will focus on changing people’s knowledge, attitudes and behaviors in relation to the use of antimicrobials.

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October 27

NIH’s I-Corps boot camp aims to transform researchers into better businesspeople before they launch products

Covance, Frenova form partnership to share patient databases, find effective treatments for renal disease

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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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Standout sponsors reveal how they shorten regulatory, clinical cycle times

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