Europe

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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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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CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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