Theorem Clinical Research

Ethics/Regulatory

Health advocate coalition says EMA advice for fee undermines independence of regulatory authorities

Monday, September 15, 2014 12:18 PM

Health Action International Europe (HAI Europe), the International Society of Drug Bulletins (ISDB), the Medicines in Europe Forum (MiEF) and the Association Internationale de la Mutualité (AIM) have criticized the EMA for providing confidential “advice” to pharmaceutical companies on their development plans for new medicines in exchange for fees—a potentially harmful practice the EMA now is trying to extend to national health technology assessment (HTA) bodies in the E.U.

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NICE to seek greater access to clinical trial data when appraising drugs

Thursday, September 11, 2014 01:32 PM

NICE will ask for access to clinical trial data from European regulatory authorities if pharmaceutical companies fail to supply all relevant data. The move follows calls for increasing transparency from pharma companies and comes after Roche was criticized for its handling of data for the pandemic flu drug Tamiflu.

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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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