Theorem Clinical Research

Ethics/Regulatory

WIRB-Copernicus Group acquires New England IRB

Wednesday, September 10, 2014 09:12 AM

By Ronald Rosenberg
CenterWatch Staff Writer

New England IRB (NEIRB) will become part of the growing group of recently acquired IRBs by WIRB-Copernicus Group (WCG), the world’s largest provider of regulatory and ethical review services for clinical research.

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NICE releases guidelines to improve recording of drug allergies

Wednesday, September 3, 2014 12:43 PM

Redesigning prescriptions to include information on drugs or drug classes that patients with known drug allergies should avoid can reduce the risk of allergic reactions, according to the National Institute of Health and Care Excellence (NICE).

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WHO recommends use of testing to help diagnose pre-cancerous cervical disease

Friday, August 29, 2014 10:33 AM

The World Health Organization (WHO) has issued new guidance recommending the use of p16 immunohistochemistry (IHC) testing to improve the detection of pre-cancerous cervical disease. In doing so, WHO is the first global organization to issue written recommendations on the use of p16 after the College of American Pathologists (CAP) and the American Society for Colposcopy and Cervical Pathology (ASCCP) provided similar guidance in 2012.

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NIH releases new priority list of drugs it wants tested in children

Thursday, August 28, 2014 01:09 PM

The NIH has released a new "Priority List" of pediatric therapeutic areas and medical products it wants the medical community—including the pharmaceutical and biopharmaceutical industries—to focus on.

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NIH issues finalized policy on genomic data sharing

Thursday, August 28, 2014 01:05 PM

The NIH has issued a final NIH Genomic Data Sharing (GDS) policy to promote data sharing as a way to speed the translation of data into knowledge, products and procedures that improve health while protecting the privacy of research participants. The final policy was posted in the Federal Register Aug. 26 and published in the NIH Guide for Grants and Contracts Aug. 27.

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YourEncore launches regulatory center of excellence

Friday, August 8, 2014 01:12 PM

YourEncore, which helps life sciences, consumer products and food companies solve complex innovation, compliance and productivity challenges, has launched the Regulatory Center of Excellence, to provide life sciences companies with industry-accomplished experts to guide them through complex regulatory requirements, from phase I trials through approval.

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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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Report: U.K. dementia diagnosis has increased 62% in seven years

Thursday, July 31, 2014 12:38 PM

According to Health and Social Care Information Center (HSCIC), provisional figures show 344,000 patients in the U.K. had a recorded diagnosis of dementia in 2013-2014. This is a rise from 319,000 in 2012-2013 and from 213,000 in 2006-2007, when the data was first collected.

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ESMO concerned about impact of proposed E.U. data protection regulation on cancer research

Monday, July 28, 2014 03:01 PM

ESMO (the European Society of Medical Oncology) has expressed concern the proposed E.U. General Data Protection Regulation could make cancer research impossible and add a significant burden to both doctors and cancer patients.

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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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