Theorem Clinical Research

Europe

NHS England consults on plans for a sustainable Cancer Drugs Fund

Tuesday, October 7, 2014 10:00 AM

NHS England is proposing changes to the way its Cancer Drugs Fund (CDF) operates, so that it delivers maximum benefit for patients, within the resources available.

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EMA launches new patient-reported suspected side effects web site

Monday, October 6, 2014 03:45 PM

European citizens now can obtain information on suspected side effects, also known as suspected adverse drug reactions, of an additional 1,700 active substances contained in medicines approved in the European Union (E.U.) through a newly launched web site maintained by the EMA.

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EMA to publish clinical reports effective January 2015

Friday, October 3, 2014 10:57 AM

The EMA has decided to publish clinical reports that underpin the decision-making on medicines. Following extensive consultations held by the agency with patients, healthcare professionals, academia, industry and other European entities over the past 18 months, the EMA management board unanimously adopted the new policy Oct. 2. It will apply to clinical reports contained in all applications for centralized marketing authorizations submitted after that date. The reports will be released as soon as a decision on the application has been taken. The policy will enter into force in January 2015.

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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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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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The CenterWatch Monthly

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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