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Myos, Cloud Pharmaceuticals ink agreement

Friday, July 18, 2014 01:32 PM

Myos, a biotherapeutics and bionutrition company focused on the discovery, development and commercialization of products that improve muscle health and performance, has entered into an R&D agreement with Cloud Pharmaceuticals.

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WIRB Copernicus Group

AbbVie to acquire Shire in $54.6 billion deal

Friday, July 18, 2014 10:24 AM

The boards of AbbVie and Shire have reached agreement on the terms of a recommended combination of Shire with AbbVie that values Shire at approximately $54.61 billion.

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Seven U.K. research councils collaborate on antimicrobial resistance

Thursday, July 17, 2014 12:50 PM

The Medical Research Council (MRC) will lead an initiative of seven research councils, backed by eight government bodies and the Wellcome Trust, to tackle antimicrobial resistance (AMR) on all fronts. The seven research councils are the Arts and Humanities Research Council, Biotechnology and Biological Sciences Research Council, Economic and Social Research Council, Engineering and Physical Sciences Research Council, MRC, Natural Environment Research Council and Science and Technology Facilities Council.

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PHT selects Windows 8.1 tablets to run SitePad System for clinical trials

Thursday, July 17, 2014 12:50 PM

PHT, a provider of technologies used to collect patient-driven eData for clinical research, has selected Dell Venue 11 Pro tablets featuring Windows 8.1 to run its SitePad System. The SitePad System replaces traditional paper data collection methods in clinical research with electronic methods, providing better-quality data, real-time access to that data and, ultimately, faster time to data analysis for pharmaceutical trial sponsors. The SitePad System is used in clinical trials to collect clinician- and patient-reported outcomes for supporting label claims of new therapies.

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Pfizer to acquire InnoPharma

Thursday, July 17, 2014 12:48 PM

Pfizer has entered an agreement to acquire InnoPharma, a privately held pharmaceutical development company, for an upfront cash payment of $225 million, with up to $135 million of contingent milestone payments.

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Life Sciences Hub Wales launched

Thursday, July 17, 2014 12:45 PM

The Welsh government has launched the Life Sciences Hub Wales, a national and international focal point for the life sciences and healthcare sectors in Wales. The life sciences hub will be based in Cardiff Bay and will bring together academic, business, clinical, professional services and funding organizations.

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INC Research names Carol Aliyar senior vice president, study start-up

Thursday, July 17, 2014 12:20 PM

INC Research, a global phase I to IV CRO has announced the promotion of Carol Aliyar to senior vice president, study start-up. Aliyar will be responsible for leading the company¹s global site engagement and study start-up efforts, including study start-up operations, site identification, site start-up and activation, ethics and regulatory submissions/approval and patient recruitment. Aliyar will focus on fostering strong site relationships to optimize timelines and deliver rapid study start-up for global clinical trials, establishing the foundation for successful collaboration across the duration of a study.

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FDA approves Ruconest for hereditary angioedema attacks

Thursday, July 17, 2014 10:49 AM

The FDA has approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

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Banner Alzheimer's Institute, Novartis partner

Wednesday, July 16, 2014 01:21 PM

Researchers from the Banner Alzheimer's Institute (BAI) have partnered with Novartis in a pioneering medical trial to determine whether two investigational anti-amyloid drugs—an active immunotherapy and an oral medication—can prevent or delay the emergence of symptoms of Alzheimer's in people at particularly high risk for developing the disease at older ages.

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Report: U.K. cancer patients face increasing coverage restrictions

Wednesday, July 16, 2014 01:18 PM

New research results quantify the extent to which centralized value assessments by the U.K.’s National Institute for Health and Care Excellence (NICE) lead to coverage denials and patient access restrictions to new drugs and biologics. The analysis, conducted by Context Matters, a healthcare information and data analytics technology platform company, and sponsored by the Pharmaceutical Research and Manufacturers of America (PhRMA), shows use of centralized cost-effectiveness standards by NICE and similar appraisals in other countries limit patients’ access to new cancer treatments, which evolve rapidly and are increasingly personalized. 

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July 28

WCG acquires Alliance Biosciences to expand its biosafety oversight capabilities, ensure compliance

Facilitated review meetings for protocol design catching on, decreasing amendments, complexity

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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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