Europe

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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WIRB Copernicus Group

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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CRF Health eCOA webinar series

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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Report: Growing divide between drug development, healthcare system in U.K.

Friday, April 11, 2014 12:02 PM

The Association of the British Pharmaceutical Industry (ABPI) has issued a report that findsover half of the active products in the global industry research pipeline are personalized medicines, and the U.K. healthcare system is at risk of failing to adapt to this new challenge. The report highlights the emergence of specialized medicines as a key challenge for the U.K. pharmaceutical industry and says for the commercial environment in the U.K. to respond to this challenge, a fundamental shift in the Health Technology Assessment (HTA) approaches is needed.

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EMA, Australian regulators strengthen collaboration in orphan medicines

Wednesday, April 9, 2014 12:38 PM

In a meeting at the EMA April 4, the EMA’s executive director, Guido Rasi, and the national manager of the Australian Therapeutic Goods Administration (TGA), John Skerritt, announced the two regulators have agreed to share the full assessment reports related to marketing authorizations of orphan medicines, intended to treat rare diseases.

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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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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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CRO market poised for growth and consolidation
Sponsors expanding pipelines, shrinking infrastructure fuel strategic outsourcing

Strategies for success evolving in phase I space
Sites see increasing complexity, more patients, greater focus on efficacy

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