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EMA approves GSK’s Malaria vaccine

Wednesday, July 29, 2015 11:50 AM

GlaxoSmithKline (GSK) has received a positive opinion for its malaria vaccine candidate from the Committee for Medicinal Products for Human Use (CHMP) of the EMA. The vaccine candidate Mosquirix (RTS,S) is the first QS-21 Stimulon containing product to receive a positive regulatory decision.

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Quest Diagnostics

Greenphire appoints Sue Vestri new chief financial officer

Wednesday, July 29, 2015 11:49 AM

Greenphire, a King of Prussia, Pa.-based provider of payment technologies for the clinical trials industry, has appointed Sue Vestri as chief financial officer. Vestri will be responsible for developing and driving the financial strategy for Greenphire, including working with the senior team to drive the company’s mission and help execute its growth plans.

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Progenics receives FDA Breakthrough Therapy for Azedra

Wednesday, July 29, 2015 11:48 AM

The FDA has designated Progenics Pharmaceuticals’ Azedra as a Breakthrough Therapy for the treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma. Azedra currently is being evaluated in a pivotal phase IIb trial, which is being conducted under a Special Protocol Assessment Agreement (SPA), and has received Orphan Drug and Fast Track designations from the FDA.

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Sanofi, Regeneron collaborate on immuno-oncology

Wednesday, July 29, 2015 11:47 AM

Sanofi and Regeneron Pharmaceuticals have entered into a new global collaboration to discover, develop and commercialize new antibody cancer treatments in the emerging field of immuno-oncology. The two companies will jointly develop a programmed cell death protein 1 (PD-1) inhibitor currently in phase I testing, and plan to initiate clinical trials in 2016 with new therapeutic candidates based on ongoing, innovative preclinical programs.

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Hikma acquires Roxane Laboratories

Wednesday, July 29, 2015 11:46 AM

Hikma Pharmaceuticals, a multinational pharmaceutical group, has agreed to acquire Boehringer Ingelheim Roxane and Roxane Laboratories from Boehringer Ingelheim. Roxane is a well-established U.S. specialty generics company with a highly differentiated product portfolio and best-in-class R&D capabilities.

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Certara launches Simcyp In Vitro (Data) Analysis Toolkit

Wednesday, July 29, 2015 11:45 AM

Certara, a Princeton, N.J.-based, global biosimulation technology-enabled drug development company, launched its Simcyp In Vitro (Data) Analysis (SIVA) Toolkit, version 1.0. The SIVA Toolkit is designed to enable the analysis of complex in vitro studies, including those with whole cells, tissue samples and solid dosage forms. It combines the latest model-based data analysis approaches to assess the metabolism, transport or dissolution/solubility of drugs with powerful optimization algorithms in a sophisticated statistical environment. This approach ensures that users do not need to have extensive modeling or statistical experience to use the toolkit.

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Clincierge expands clinical concierge services for trial participants and families

Wednesday, July 29, 2015 11:44 AM

Clincierge, a Philadelphia-based provider of specialized services and personalized support designed to overcome barriers to patient participation in clinical studies, expanded its patient concierge service into Cyprus. This is the 30th country where the company’s high-touch, one-on-one services for patients and families are available to aid companies conducting clinical trials increase trial enrollment and improve patient retention, thus helping to ensure that costly studies complete on time and on budget.

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Deerfield launches $550M healthcare venture-capital fund

Wednesday, July 29, 2015 11:41 AM

Deerfield Management has launched the Deerfield Healthcare Innovations Fund, which will invest in groundbreaking advancements in science that may lead to therapeutic interventions in genetic diseases, cancer and orphan diseases. The venture capital fund also will back new technologies that can transform how therapeutics are developed and improve the way healthcare is delivered to patients.

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Charles River Laboratories acquires Celsis International

Wednesday, July 29, 2015 11:40 AM

Celsis International, a global supplier of rapid microbial detection systems, has been acquired by Charles River Laboratories International, a Wilmington, Mass.-based CRO, for $212 million in cash. 

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Merck acquires cCAM Biotherapeutics for $95M in cash

Wednesday, July 29, 2015 11:38 AM

Merck & Co has signed a definitive agreement to acquire cCAM Biotherapeutics, a privately held, Israel-based biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies.

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CWWeekly

July 27

AB Science warned about putting study volunteers in danger

FDA, Google unite to detect search-data adverse events

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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