Theorem Clinical Research

Europe

Guideline outlines applications for pediatric investigation plans

Thursday, October 2, 2014 02:29 PM

The European Commission (E.C.) has published a revised guideline on applications for pediatric investigation plans, or PIPs, in the Official Journal of the European Union. The new guideline is expected to facilitate the application process. It is intended for all medicines developers.

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Report: Small and medium-sized enterprises are driving innovation in medicines

Thursday, October 2, 2014 02:28 PM

Micro, small and medium-sized enterprises (SMEs) are a motor of innovation in the European Union (E.U.). Between 2010 and 2012, more than one in four new innovative medicines recommended for marketing authorization in the E.U. originated from SMEs, as shown in an analysis published by the EMA in January. 

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BioNTech, Ganymed Pharmaceuticals open research headquarters in Germany

Thursday, October 2, 2014 02:14 PM

BioNTech and Ganymed Pharmaceuticals, two German biotechology companies, have opened a 108,000-square-foot headquarters and research facility. The new facility brings together 300 employees and is located near academic institutions, hospitals and cancer research institutions.

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NHS chief Simon Stevens launches $1M prize fund for innovation

Thursday, October 2, 2014 02:11 PM

Simon Stevens, NHS chief executive, has launched a $1 million prize pot to reward innovation in the NHS. The NHS Innovation Challenge Prize encourages, celebrates and rewards innovation driven by the frontline doctors, nurses and NHS staff who deliver care every day. 

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Evotec partners to develop multiple sclerosis treatments

Tuesday, September 30, 2014 10:00 AM

Evotec, a German-based drug discovery alliance and development partnership company, has entered into three novel research projects for the treatment of multiple sclerosis (MS), supported by research funds from the German Federal Ministry of Education and Research (BMBF).

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Cancer Core Europe consortium launches

Friday, September 26, 2014 03:15 PM

Cancer Core Europe—a consortium to address the cancer care/research continuum challenge, has launched. Its members are Gustave Roussy Cancer Campus Grand Paris; Cambridge Cancer Center, based in the U.K.; Karolinska Institute, of Stockholm, Sweden; the Netherlands Cancer InstituteVall d'Hebron Institute of Oncology (VHIO), of Barcelona, Spain; and the German Cancer Research Center (DKFZ) and its National Center for Tumor Diseases (NCT).

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GlaxoSmithKline appoints Sir Philip Hampton to the board of directors

Thursday, September 25, 2014 02:06 PM

GlaxoSmithKline has announced that Sir Philip Hampton will join the board of the company as non-executive director January 2015 and will become deputy chairman effective April 2015. He will succeed Sir Christopher Gent.

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ABPI comments on NICE’s response to value-based assessment consultation

Friday, September 19, 2014 12:50 PM

The National Institute for Health and Care Excellence (NICE) board has considered proposals on value-based assessment (VBA) following a three-month consultation.

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Icon’s Cynthia Dukes voted one of the world’s Most Influential People in Vaccines

Thursday, September 18, 2014 12:49 PM

Icon, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has announced that Cynthia Dukes, vice president, global project management, vaccines, infectious disease, women’s health and primary care, has been voted one of the 50 Most Influential People in Vaccines following a global industry survey conducted by vaccine industry organization, VaccineNation. Cynthia was the only CRO representative included in the list.

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Health advocate coalition says EMA advice for fee undermines independence of regulatory authorities

Monday, September 15, 2014 12:18 PM

Health Action International Europe (HAI Europe), the International Society of Drug Bulletins (ISDB), the Medicines in Europe Forum (MiEF) and the Association Internationale de la Mutualité (AIM) have criticized the EMA for providing confidential “advice” to pharmaceutical companies on their development plans for new medicines in exchange for fees—a potentially harmful practice the EMA now is trying to extend to national health technology assessment (HTA) bodies in the E.U.

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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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