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Safe-Biopharma launches cyber security consulting service for life science, healthcare

Friday, April 24, 2015 01:18 PM

SAFE-BioPharma Association has created SBP Digital Trust Consulting, a resource of internationally recognized identity and access management (IAM) policy and technical experts for life science and healthcare companies seeking to develop improved cyber security strategies.

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Quest Diagnostics

Accenture, Oracle expand Life Sciences Cloud for R&D

Friday, April 24, 2015 01:14 PM

Accenture, a global management consulting, technology services and outsourcing company, has expanded the Accenture Life Sciences Cloud for R&D, powered by Oracle, with the addition of enhanced clinical data management capabilities. This enables life sciences companies to generate high-quality, reliable and statistically sound data from clinical trials to reduce the time, effort and cost needed to take drugs from development to market.

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Sartorius Stedim Biotech acquires BioOutsource

Friday, April 24, 2015 12:29 PM

Sartorius Stedim Biotech (SSB), an international supplier for the biopharmaceutical industries, has acquired Scottish company BioOutsource. The privately owned company based in Glasgow, U.K., has been operating in the biotechnology market since 2007 and has approximately 85 employees. No financial details have been disclosed.

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Ebola vaccine trial begins in Sierra Leone

Thursday, April 23, 2015 03:08 PM

The Centers for Disease Control and Prevention (CDC), in partnership with the Sierra Leone College of Medicine and Allied Health Sciences (COMAHS) and the Sierra Leone Ministry of Health and Sanitation (MoHS), now is enrolling and vaccinating volunteers for the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). This study will assess the safety and efficacy of the rVSV-ZEBOV candidate Ebola vaccine among health and other frontline workers.

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Teva proposes to acquire Mylan for $82 per share in cash and stock

Wednesday, April 22, 2015 12:14 PM

Teva Pharmaceutical Industries has proposed to acquire all of the outstanding shares of Mylan in a transaction valued at $82 per Mylan share, with the consideration to be comprised of approximately 50% cash and 50% stock. The Teva cash and stock proposal provides Mylan stockholders with a substantial premium and immediate cash value, as well as significant potential for future value creation through participation in a financially and commercially stronger company.

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Curadev, Roche ink research cancer immunotherapeutic collaboration

Wednesday, April 22, 2015 12:13 PM

Curadev Pharma, headquartered in New Delhi, India, has entered into a research collaboration and exclusive license agreement with Roche for the development and commercialization of IDO1 and TDO inhibitors. The agreement covers the development of the lead preclinical immune tolerance inhibitor and a research collaboration with Roche's research and early development organization to further explore the IDO and TDO pathways.

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CluePoints, Oracle Health Sciences collaborate

Wednesday, April 22, 2015 12:09 PM

CluePoints, a Cambridge, Mass.-based provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, is collaborating with Oracle Health Sciences, combining CluePoints' risk-based monitoring (RBM) solution with Oracle’s clinical data capture and management platform, Oracle Health Sciences Inform Cloud Service. The resulting solution can help deliver a complete trial review process that proactively identifies risk in both clinical and operational data throughout a clinical trial. These include operational risks, such as those outlined by industry consortiums, as well as risks seen through the analysis of clinical data that highlight anomalies or inconsistent data patterns at study, region or site levels that otherwise may not have been identified.

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Takeda collaborates with Keio University, Niigata University

Wednesday, April 22, 2015 11:58 AM

Takeda Pharmaceutical has signed an agreement to undertake collaborative research with Keio University School of Medicine (Shinjuku Ward, Tokyo) and Niigata University (Niigata City, Niigata) at Takeda’s Shonan Research Center (Fujisawa City, Kanagawa) regarding the search for and functional analysis of disease-related RNA-binding proteins. This may lead to treatments in CNS and oncology.

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EMA scientific advice leads to higher success rates, shorter assessment times

Tuesday, April 21, 2015 07:58 AM

The majority of clinical development plans submitted for scientific advice to the European Medicines Agency (EMA) prior to a marketing authorization application were found not suitable for future benefit-risk assessment. Companies that changed their clinical development plans in accordance with the recommendation from EMA were more likely to be granted a marketing authorization.

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PPD Laboratories opens central lab in Shanghai

Tuesday, April 21, 2015 07:56 AM

Global CRO PPD has opened a central laboratory in Shanghai, China, to deliver global scientific and technical lab expertise to meet growing client demand for these services in China. The new facility, which has been established in association with Shanghai Clinical Research Center (SCRC), will provide high-quality data across a range of technologies and applications for all phases of pharmaceutical development.

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April 20

Christie Clinic, PMG Research's 12th clinical research site, expands its geographic reach north to Illinois

Clinipace acquires Accovion to expand European presence, following an infusion of equity that could lead to more deals

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PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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