Theorem Clinical Research

Ethics/Regulatory

EMIG welcomes Parliamentary inquiry into NICE

Monday, January 6, 2014 11:52 AM

The Ethical Medicines Industry Group (EMIG) has welcomed the House of Commons Health Select Committee's inquiry into the National Institute for Health and Clinical Excellence (NICE). This is an opportunity for the SME specialist biopharmaceutical sector to reflect on the workings of the medicines regulator, in particular its future role in supporting the new commissioning environment and how the value of innovative new medicines will be assessed.

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Regulators, HTA dialogue key to medicines development

Tuesday, December 3, 2013 08:30 AM

“A strong interaction between regulators and health technology assessment bodies (HTAs) is critical to enable innovation to reach patients, and ultimately for the benefit of public health,” said Guido Rasi, executive director of the EMA.

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Industry responds to European clinical trials regulation revision

Monday, December 2, 2013 01:09 PM

There is an increasing international competition in clinical trials because clinical research creates jobs, drives academic excellence and delivers innovative medicines for patients. Improving the attractiveness and competitiveness of Europe as a prime location for clinical research was a key driver for the revision of the E.U. clinical trial legislation, which aimed to reduce unnecessary red tape whilst preserving the quality and safety of clinical trials.

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European Medicines Agency, EUnetHTA publish joint work plan

Wednesday, November 20, 2013 12:47 PM

The European Medicines Agency (EMA) and EUnetHTA, the European network for Health Technology Assessment, have published a joint three-year work plan outlining key areas of collaboration.

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MHRA, BIA call for earlier access to medicines in the U.K.

Monday, November 18, 2013 01:39 PM

Following the publication of the report on innovation in the regulation of healthcare by the Medicines and Healthcare Products Regulatory Agency (MHRA), the BioIndustry Association (BIA) urges the U.K. government to implement a properly funded and reimbursed Earlier Access to medicines Scheme (EAS), which the group makes its number one recommendation.

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Pfizer responds to U.K. pharma pricing deal

Wednesday, November 6, 2013 12:43 PM

Pfizer released a statement calling the new Pharmaceutical Price Regulation Scheme (PPRS), agreed to by the U.K. government and industry, a missed opportunity for British patients, the U.K. economy and industry.

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FDA approves first medicine with Breakthrough Therapy designation

Monday, November 4, 2013 01:35 PM

Genentech, a member of the Roche Group, has announced that the FDA approved Gazyva (obinutuzumab), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL).

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FDA takes two actions on drug shortages

Friday, November 1, 2013 11:14 AM

The FDA is taking two actions to further enhance its ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients. Following the President’s 2011 Executive Order to reduce drug shortages, the number of new shortages in 2012 fell to 117, down from 251 in 2011. 

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NHS fears changing data protection rules could erode quality of research in U.K.

Friday, October 25, 2013 11:48 AM

The NHS European office and the Royal College of Physicians have warned a new Europe-wide law on data protection could have a negative impact on healthcare provision and erode the quality and effectiveness of health research in the U.K.

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FDA awards 15 grants to stimulate drug, device development for rare diseases

Wednesday, October 23, 2013 02:36 PM

The FDA has awarded 15 grants totaling more than $14 million to boost the development of products for patients with rare diseases.

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October 13

First Sunshine Act data posted online; many cite errors, lack of context to help consumers understand payments

In appreciation: Felix Gyi will be remembered for his passion, leadership and desire to educate, pay it forward

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October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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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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