Global News

CluePoints: Determining best approach is industry's biggest challenge to implementing risk-based monitoring

Wednesday, August 6, 2014 08:40 AM

A survey by CluePoints, a provider of centralized statistical monitoring (CSM) solutions for clinical trials, has revealed 42% of respondents across the industry say agreeing to the best and most practical approach is the biggest challenge their organizations face in implementing an effective Risk-Based Monitoring (RBM) strategy.

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WIRB Copernicus Group

ACRES, Fujitsu form strategic alliance around technology

Wednesday, August 6, 2014 08:37 AM

The Alliance for Clinical Research Excellence and Safety (ACRES) has formed a strategic alliance with Fujitsu, a global information and communication technology company, to address challenges facing the development of medicines and health-related research endeavors.

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Telik completes merger with MabVax Therapeutics

Tuesday, August 5, 2014 10:00 AM

MabVax Therapeutics, a privately held cancer immunotherapy company, and Telik, a clinical stage oncology drug development company, have merged. MabVax became a wholly owned subsidiary of Telik effective July 8, following Telik stockholder approval at Telik's annual meeting of stockholders July 7.

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HeartWare International appoints Katrin Leadley chief medical officer

Monday, August 4, 2014 03:48 PM

HeartWare International, an innovator of less invasive, miniaturized circulatory support technologies for advanced heart failure, has appointed Katrin Leadley, M.D., as chief medical officer of HeartWare, effective September 1. Leadley brings to HeartWare extensive strategic leadership, with more than 20 years of clinical and industry experience at life sciences firms, including QuintilesBoston Scientific and JenaValve Technology in Munich, where she spent the last three years as chief medical officer leading the company's clinical, regulatory, scientific and medical activities.

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Roche to acquire Santaris Pharma for $450M

Monday, August 4, 2014 02:14 PM

Roche has agreed to acquire Santaris Pharma, a privately held biopharmaceutical company based near Copenhagen, Denmark. Santaris Pharma has pioneered its proprietary Locked Nucleic Acid (LNA) platform that has contributed to an emerging era of RNA-targeting therapeutics. This new class of medicines has the potential to address difficult to treat diseases in a range of therapeutic areas.

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Pfizer, Roche join ADDPLAN DF Consortium

Monday, August 4, 2014 02:12 PM

Pfizer and Roche have joined the ADDPLAN DF Consortium. The consortium was founded in 2013 by Novartis, Janssen PharmaceuticalsEli Lilly and Aptiv Solutions, an Icon company, to lead the design and implementation of adaptive trials. The goal of the ADDPLAN DF Consortium is to develop methodologies and execution technologies that improve dose-selection, which remains a major barrier to resolving high failure rates in phase III trials.

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Allergan files federal lawsuit against Valeant, Pershing Square

Monday, August 4, 2014 02:10 PM

Allergan has filed a lawsuit against Valeant Pharmaceuticals InternationalPershing Square Capital Management and its principal, William A. Ackman, alleging that Valeant, Pershing Square and Ackman violated federal securities laws prohibiting insider trading, engaged in other fraudulent practices and failed to disclose legally required information.

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BioElectronics president outlines four-part growth strategy

Monday, August 4, 2014 02:09 PM

In a letter to shareholders, Andrew J. Whelan, president of BioElectronics, emphasized a four-part growth strategy initiated in the last year. 

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Molecular Profiles, Xenogesis partner

Monday, August 4, 2014 01:57 PM

Molecular Profiles, a contract development and manufacturing organization (CDMO) subsidiary of Columbia Laboratories, and CRO XenoGesis are collaborating to support pharmaceutical and biotech drug developers during the preclinical and formulation development stage. Molecular Profiles' pharmaceutical development services will be supported by XenoGesis' experience in preclinical drug metabolism and pharmacokinetics (DMPK) to give clients a smarter route into formulation development and a better understanding of a compound's bioavailability.  

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The Pulse on Global Trials

Monday, August 4, 2014 07:00 AM

As innovations in global healthcare continue to be explored, there is a heightened urgency among industry professionals to understand the rules of clinical trial recruitment, how they vary by region and what they mean for using digital channels such as online advertising, search engine marketing and social media to engage prospective participants.

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CWWeekly

August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

Sponsors look to the power of genomic profiling to screen, enroll patients in trials for targeted therapies

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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