Europe

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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European researchers to submit proposals focused on curing virological diseases

Tuesday, April 8, 2014 02:41 PM

In a quest to cure chronic virological diseases such as HIV, hepatitis B and hepatitis C, Bristol-Myers Squibb has asked European researchers—notably junior faculty and young investigators—to submit innovative research ideas  to accelerate novel solutions as part of its Partnering for Cure program.

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Europe approves clinical trial transparency law

Monday, April 7, 2014 12:39 PM

Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with E.U. ministers and passed by Parliament. The law also facilitates cross-border cooperation to make clinical trials larger, more viable and more reliable, which should in turn boost efforts to develop special treatments (e.g. for rare diseases).

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Proposed health IT strategy aims to promote innovation, protect patients, avoid duplication

Friday, April 4, 2014 12:05 PM

HHS has released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.

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New structure for NIHR Clinical Research Network

Thursday, April 3, 2014 11:06 AM

The National Institute for Health Research (NIHR) Clinical Research Network, which provides more than $471.4 million a year to support the delivery of clinical research studies in the NHS, has reconfigured and will be operating in a new streamlined structure.

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Health Research Authority business plan approved to streamline research in U.K.

Wednesday, April 2, 2014 01:44 PM

The U.K. Department of Health has approved the Health Research Authority (HRA) funding plans for HRA Assessment and Approval. This funding means the HRA will be able to reduce duplication and bureaucracy by incorporating assessments by NHS staff alongside the independent Research Ethics Committee opinion, which will result in one application, one assessment and one approval for research in the NHS in England.

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NICE seeks views on how it assesses drugs and other technologies for the NHS

Friday, March 28, 2014 03:15 PM

The National Institute for Health and Care Excellence (NICE) has begun a formal consultation on proposed changes to the way it makes recommendations on new medicines and other treatments for use in the NHS. NICE assesses the clinical and cost effectiveness of new technologies to help ensure patients have access to effective treatments and the NHS makes the best use of its resources.

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Onkodatamed joins Medis

Thursday, March 20, 2014 02:36 PM

Berlin-based clinical research alliance, Medis Research Group, has added Berlin-Brandenburg-based Onkodatamed to its portfolio. Medis Research Group, founded in November, previously consisting only of its two founding members, Allied Clinical Management and ICRC-Weyer, both Berlin-based CROs. The group was formed to better meet requirements of clinical trial sponsors for one-stop shop solutions, hence enabling the two CROs to combine clinical research experience and provide complete service solutions across all stages of the clinical development process.

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December 15

Cancer Treatment Centers of America chooses WCG as its exclusive IRB, sheds five local hospital IRBs

Five southern research groups form public-private network to help save time, money for clients with early-stage biologics

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The CenterWatch Monthly

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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November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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