Theorem Clinical Research

Europe

AstraZeneca, University of Cambridge strengthen partnership

Friday, October 17, 2014 12:46 PM

AstraZeneca, together with its global biologics R&D arm MedImmune, has entered into four new collaborations with the University of Cambridge, building further on their existing partnership. The latest collaborations reinforce AZ’s commitment to creating a permeable research infrastructure in Cambridge following its decision to locate one of its three global R&D centers and its global headquarters in the city, which has been home to MedImmune’s biologics research laboratories for 25 years.

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Treeway, LACDR collaborate on ALS therapy development

Thursday, October 16, 2014 02:36 PM

Treeway, a Netherlands-based, amyotrophic lateral sclerosis (ALS) R&D strategy-focused company, and the Leiden Academic Center for Drug Research (LACDR) at the University of Leiden, the Netherlands, have formed a collaboration focused on the optimization of clinical trial designs and data analysis for ALS through the use of population disease progression models. Both parties aim to obtain a better understanding of the disease by developing ALS physiology-based disease models and test the effect of interventions in the different identified pathways.

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New U.K. health campaign urges people with diabetes to 'TALK Hypos'

Thursday, October 16, 2014 02:27 PM

The TALK Hypos awareness campaign has launched in the U.K., supported by Novo Nordisk and Diabetes U.K., encouraging people with diabetes to report hypoglycemia (hypos) to their doctor or nurse.

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KCR launches KCR Date Forecaster app for medical appointment scheduling

Wednesday, October 15, 2014 09:00 PM

KCR, a European CRO, has launched KCR Date Forecaster, a mobile application providing patients with smart scheduling and automatic reminders for doctor appointments and medical examinations. 

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NICE develops new guidelines for antibiotic resistance

Wednesday, October 15, 2014 01:39 PM

NICE is developing two new guidelines to help tackle the growing threat of antibiotic resistance. The first is on safe and effective antimicrobial stewardship in relation to the use of antimicrobials in health and social care, and the second is a public health guideline that will focus on changing people’s knowledge, attitudes and behaviors in relation to the use of antimicrobials.

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U.K. public believes not enough is being spent on medicines

Thursday, October 9, 2014 11:35 AM

A new survey has found more than half (52%) of English adults believe that not enough of the NHS budget is being spent on medicines. The survey was commissioned by the Association of the British Pharmaceutical Industry (ABPI), which includes research-based biopharmaceutical companies in the U.K.

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Report: U.K. leads Europe in capital raised and pipeline of products

Thursday, October 9, 2014 11:00 AM

The U.K. biotech ecosystem continues to flourish based on strong fundamentals, according to a new State of the Nation report by Ernst & Young and the BioIndustry Association (BIA), a trade association for innovative enterprises involved in U.K. bioscience.

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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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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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