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Bristol-Myers Squibb withdraws NDA with FDA for asunaprevir

Thursday, October 9, 2014 11:51 AM

Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the U.S. and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which currently is being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

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Chimerix receives Emergency Investigational NDA for Ebola

Thursday, October 9, 2014 11:45 AM

Chimerix, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, has announced that brincidofovir has been provided for potential use in patients with Ebola virus disease. These requests were made by treating physicians. Emergency Investigational New Drug Applications (EIND) were granted by the FDA.

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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: CROs an innovation partner in clinical trials

Thursday, October 9, 2014 11:33 AM

“Clinical trials today are more responsive, individualized and effective because it’s written into the DNA of CROs to challenge the status quo,’’ according to a new Association of Clinical Research Organizations (ACRO) report, Clinical Research: A Legacy of Innovation, A Future of Transformed Medicine.

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CSL Behring expands manufacturing capabilities

Thursday, October 9, 2014 11:32 AM

CSL Behring, a King of Prussia, Pa.-based provider of plasma protein therapeutics, has announced a multi-year, $450-million two-site global capacity expansion, the latest in a series of recent production expansions to meet the growing need for therapies used to treat patients with rare and serious medical disorders around the world. 

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CRF Health names Sarah Dixon vice president of human resources

Thursday, October 9, 2014 11:30 AM

CRF Health, a global provider of eCOA solutions for the Life Sciences Industry, has appointed Sarah Dixon the company's vice president of human resources.

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Bristol-Myers Squibb researchers receive a 2014 PhRMA Research and Hope Award

Thursday, October 9, 2014 11:22 AM

Bristol-Myers Squibb scientists have received the 2014 Pharmaceutical Research and Manufacturers of America (PhRMA) Research and Hope Award for Biopharmaceutical Industry Research excellence. This year’s award program honored outstanding individuals and organizations for their commitment and progress in the field of HIV/AIDS research.

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Quest Diagnostics names Franklin R. Cockerill VP, chief laboratory officer

Thursday, October 9, 2014 11:10 AM

Quest Diagnostics, a provider of diagnostic information services, has announced that Franklin R. Cockerill, III, M.D., has joined the company as vice president and chief laboratory officer, effective Oct. 1.

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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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MyCartis launches Evalution, a next generation multiplex biomarker analysis platform

Thursday, October 9, 2014 10:30 AM

MyCartis, a Switzerland and Belgium-based new company dedicated to changing healthcare through personalization originating from Biocartis’ business unit Evalution and Pronota, has launched Evalution, a multiplex biomarker analysis platform for the life sciences research market.

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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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