Europe

EMA responds to concerns on its publication of clinical trial data policy

Thursday, June 12, 2014 01:36 PM

The EMA Management Board meeting will consider a draft policy on the publication of clinical trial data. The draft policy arises from the agency’s commitment to increase access to clinical trial data and has been shaped by the many comments received during the consultation phase.

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EFPIA calls for universal adherence to European regulatory framework

Wednesday, June 11, 2014 12:51 PM

EFPIA, the European Federation of Pharmaceutical Industries and Associations, is concerned about a decision by the Italian health authority to allow the reimbursement of off-label treatments for economic reasons when on-label alternatives are available. The organization calls on the European Commission to ensure member states adhere to the European regulatory framework and that financial considerations do not take precedence over regulatory decisions. 

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Medical Research Council, Technology Strategy Board announce $80.6M for biomedical research

Wednesday, June 11, 2014 12:47 PM

Science MinisterDavid Willetts has announced $80.6million of new investment in biomedical research. The Biomedical Catalyst is a scheme run jointly by the Medical Research Council and the U.K.’s innovation agency, the Technology Strategy Board, to find solutions to healthcare challenges. It supports the best life science opportunities in the U.K. to help speed up the transition from discovery science to commercial application.

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EFPIA launches vision for European life sciences strategy

Friday, June 6, 2014 12:56 PM

EFPIA, the European Federation of Pharmaceutical Industries and Associations, has launched a paper outlining steps toward an integrated strategy for the life sciences sector in Europe.

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EMA welcomes publication of the Clinical Trials Regulation

Friday, May 30, 2014 01:38 PM

The EMA welcomes the publication of the Clinical Trials Regulation in the Official Journal of the European Union (E.U.). This legislation will foster European competitiveness and innovative capacity, and facilitate swifter development of new medicines for patients. In addition to simplifying clinical trial approvals, the regulation foresees transparency on the conduct of trials in the European Economic Area, from the point of their authorization to the publication of the results of those clinical trials.

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Ombudsman concerned by EMA policy change for clinical transparency

Wednesday, May 21, 2014 01:31 PM

In a letter to the EMA, the European Ombudsman, Emily O'Reilly, has expressed concern about a significant change of policy concerning clinical trial data transparency. The European Ombudsman investigates complaints about maladministration in the E.U. institutions and bodies.

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SBRI Healthcare launches new competition, $4.2M available to small businesses

Wednesday, May 21, 2014 01:27 PM

SBRI Healthcare, an NHS England funded initiative to develop innovative products and services that address unmet health needs, has launched the latest SBRI Healthcare competition with $4.2 million available to support small business.

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Report: New thinking needed for funding, development of future medicines

Thursday, May 8, 2014 01:20 PM

Pharmaceutical scientists are calling for a new covenant to be developed between the pharmaceutical industry and wider society, including government, to accelerate and incentivize the development of new types of tailored medicines and treatments.

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NHS England approves $13.5M in funding for hepatitis C drug

Thursday, April 17, 2014 11:16 AM

NHS England has approved a $13.5 million investment in Sofosbuvir for the treatment of hepatitis C. About 500 patients with acute liver failure, and/or awaiting liver transplantation, are expected to benefit from the decision to fund Gilead Sciences’ new drug.

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Report: NHS financial crunch getting closer

Wednesday, April 16, 2014 01:23 PM

Financial confidence within the NHS is ebbing away, with a financial crisis looming in 2015-2016, according to the latest Quarterly Monitoring Report published by The King's Fund.

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CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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