Theorem Clinical Research

Europe

ABPI comments on NICE’s response to value-based assessment consultation

Friday, September 19, 2014 12:50 PM

The National Institute for Health and Care Excellence (NICE) board has considered proposals on value-based assessment (VBA) following a three-month consultation.

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Icon’s Cynthia Dukes voted one of the world’s Most Influential People in Vaccines

Thursday, September 18, 2014 12:49 PM

Icon, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has announced that Cynthia Dukes, vice president, global project management, vaccines, infectious disease, women’s health and primary care, has been voted one of the 50 Most Influential People in Vaccines following a global industry survey conducted by vaccine industry organization, VaccineNation. Cynthia was the only CRO representative included in the list.

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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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Almac selected as a national champion in the 2014/15 European Business Awards

Thursday, September 11, 2014 03:43 PM

Almac, a contract development and manufacturing organization, has been named national champion in the UKTI Award for Innovation category in this year’s European Business Awards—a competition supported by businesses leaders, academics, media and political representatives across Europe. 

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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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HHS contracts with Mapp Biopharmaceutical to develop ZMapp for Ebola

Thursday, September 4, 2014 12:22 PM

The development of a medication to treat illness from Ebola will be accelerated under a contract with the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).

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Report: Children’s cancer death rates in U.K. drop more than 20% in 10 years

Wednesday, September 3, 2014 12:48 PM

The rate of children dying from cancer in the U.K. has dropped 22% in the last decade, according to new figures published by Cancer Research U.K.

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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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Survey: Pharma physicians support the principles of clinical trial transparency

Thursday, August 28, 2014 01:08 PM

The Faculty of Pharmaceutical Medicine (FPM), a professional membership organization of the Royal Colleges of Physicians of the U.K., has released results of its survey on the publication of clinical trial results and access to data.

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Report: Cancer survival in England improving using cancer staging data

Wednesday, August 27, 2014 01:17 PM

Cancer survival in England for breast, lung, prostate, colorectal and ovarian cancer continues to improve, according to new data published in a report from Public Health England’s National Cancer Intelligence Network (NCIN).

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CWWeekly

September 15

WIRB-Copernicus Group acquires New England IRB

BBK Worldwide secures $3 million in private ἀnancingto accelerate its global and technological expansion

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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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