Ethics/Regulatory

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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Quest Diagnostics

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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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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CWWeekly

April 20

Christie Clinic, PMG Research's 12th clinical research site, expands its geographic reach north to Illinois

Clinipace acquires Accovion to expand European presence, following an infusion of equity that could lead to more deals

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The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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