Theorem Clinical Research

Europe

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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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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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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August

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

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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