Theorem Clinical Research

Ethics/Regulatory

Report: EMA finds increase in rare disease medicines

Monday, February 3, 2014 10:19 AM

A total of 11 out of 81 medicines recommended for marketing authorization by the EMACommittee for Medicinal Products for Human Use (CHMP) in 2013 were intended for the treatment of rare diseases. This continues the year-on-year increase in the number of marketing authorization recommendations for medicines for rare diseases observed over the last few years (with eight in 2012 and four in 2011).

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New Breakthrough Therapy Designation shows potential to shorten drug development time

Wednesday, January 29, 2014 01:04 PM

The Breakthrough Therapy Designation (BTD) program, launched nearly 18 months ago by the FDA and aimed at expediting development and review of drugs intended to treat a serious condition, has the potential to shorten development time considerably, according to the Tufts Center for the Study of Drug Development (Tufts CSDD), which recently completed an assessment of the BTD program.

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FDA launches advisory committee membership nomination portal

Wednesday, January 22, 2014 12:56 PM

The FDA has launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees. 

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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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