Ethics/Regulatory

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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WIRB Copernicus Group

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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Analysis finds NHS could experience funding crisis before general election

Friday, July 11, 2014 11:26 AM

According to the Nuffield Trust, the NHS is poorly placed to deal with continuing austerity and could experience a funding crisis before the 2015 General Election. A new panel of 100 health and social care leaders also have raised concerns about the future sustainability of the NHS and social care. The Nuffield Trust’s Health and Social Care Leaders’ panel is a survey of NHS and social care professionals' views on the NHS and the social care system in England, and how it should be developed beyond the 2015 general election.  

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EMA recommends 39 medicines for marketing authorization in first half of 2014

Friday, July 11, 2014 11:25 AM

Thirty-nine medicines for human use were recommended for marketing authorization by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in the first half of 2014, compared with 44 in first half of 2013 and 33 in first half of 2012.

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EMA’s clinical trial data policy delayed until October

Thursday, July 10, 2014 12:53 PM

The management board of the EMA has postponed formal adoption of the policy on publication of clinical trial data until its Oct. 2 meeting. Further clarifications on wording and practical arrangements will be discussed by board members, who have confirmed their general support of the overall aim and objectives of the policy, including the more user-friendly amendments proposed by Guido Rasi, EMA executive director, that would allow data to be downloaded, saved or printed for academic and non-commercial research purposes.

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EFPIA launches IMI2—a $4.5B public-private healthcare partnership

Wednesday, July 9, 2014 12:09 PM

EFPIA has announced the launch of IMI2, the continuation of the successful partnership of industry and public bodies to tackle health needs. IMI is a public-private partnership (PPP) between the European Commission and EFPIA, the European Federation of Pharmaceutical Industries and Associations. The first phase of IMI (2008 to 2013) was established with a budget of $2.7 billion. IMI2 has been established under the E.U. framework program Horizon 2020 with an even bigger budget of $4.5 billion—bringing together the public and private sectors in the largest healthcare PPP in Europe.

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U.K. Prime Minister commissions independent antibiotics review

Wednesday, July 2, 2014 12:48 PM

U.K. Prime Minister David Cameron, along with the U.K. Department of Health, has commissioned a wide reaching independent review, led by economist Jim O’Neill and co-funded and hosted by medical research foundation the Wellcome Trust, to explore the economic issues surrounding antimicrobial resistance. Growing numbers of bacterial and viral infections are resistant to antimicrobial drugs, but no new classes of antibiotics have come on the market for more than 25 years.

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Massachusetts becomes 7th state to pass law allowing pharmacy substitution of interchangeable biosimilars

Friday, June 27, 2014 12:08 PM

By Ronald Rosenberg
CenterWatch Staff Writer

Massachusetts this week became the seventh state to allow for the substitution at the pharmacy of biosimilars deemed “interchangeable” with branded original drugs—legislation being enacted on a state-by-state basis.

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Patient-initiated Guidance for Industry for Duchenne submitted to FDA

Wednesday, June 25, 2014 01:51 PM

Parent Project Muscular Dystrophy (PPMD) and a broad coalition of stakeholders have submitted the first-ever patient advocacy-initiated draft guidance for a rare disease to the FDA to help accelerate development and review of potential therapies for Duchenne muscular dystrophy.

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

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Benefits outweigh the complexities, challenges of finding right vendors

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Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
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