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PHE drug development to transfer to new state-owned company

Friday, July 10, 2015 09:35 AM

Public Health England will transfer its drug development and production to a new company, Porton Biopharma. The transfer of Public Health England’s (PHE’s) clinical drug development and production capability into a stand-alone, state-owned biopharmaceutical limited company has been approved by the Secretary of State for Health.

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Quest Diagnostics

Sorrento, NantBioScience form joint venture

Friday, July 10, 2015 09:29 AM

Sorrento Therapeutics, a clinical stage oncology company, and NantBioScience, a majority owned subsidiary of NantWorks, have established a joint venture to focus on the development of first-in-class small molecules addressing drivers of cancer growth, including cancer stem cells. ‎Sorrento will contribute key small molecule programs (lead inhibitors of the proto-oncogenes c-Myc, and the master metabolism regulator HIF-1 alpha, and an inducer of the tumor suppressor cytokine TRAIL) to the joint venture, which will be 60% owned by NantBioScience and 40% owned by Sorrento, and funded accordingly.

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Charles River Laboratories to acquire Celsis International

Friday, July 10, 2015 08:38 AM

Charles River Laboratories International, a Wilmington, Mass.-based CRO, has entered into a definitive agreement to acquire Celsis International, a global provider of rapid bacterial detection systems for quality control testing in the biopharmaceutical and consumer products industries, for $212 million in cash. Celsis’s systems are principally used for product-release testing to help ensure the safe manufacture of drugs and consumer products.

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goBalto launches updated Activate for risk management in clinical trials

Friday, July 10, 2015 08:29 AM

goBalto, a San Francisco, Calif.-based provider of cloud-based clinical study startup solutions, has released its latest version of goBalto Activate. The second major release of 2015 offers new features that further accelerate clinical study startup.

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Parexel expands model-based drug development offering

Friday, July 10, 2015 08:20 AM

Global CRO Parexel International has launched expanded services and capabilities in model-based drug development (MBDD) through its Quantitative Clinical Development (QCD) group.  The Parexel QCD team also offers leadership in all strategic and quantitative aspects of clinical pharmacology for biopharmaceutical companies to help expedite drug development, minimize risk and support regulatory approval processes.

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Almac Group appoints two new vice presidents

Wednesday, July 8, 2015 11:43 AM

Almac Group, a global contract development and manufacturing organization, has appointed two new vice presidents at its Craigavon and Souderton headquarter facilities.

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Certara creates global strategic modeling and simulation consultancy

Wednesday, July 8, 2015 11:39 AM

Certara, a global biosimulation technology-enabled drug development company, has merged its consulting group, Pharsight Consulting Services (PCS), with Quantitative Solutions, a global pharmacometrics consulting company headquartered in Menlo Park, Calif.

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NIH-funded vaccine for West Nile virus enters human clinical trials

Wednesday, July 8, 2015 11:18 AM

A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The experimental vaccine was discovered and developed by scientists at the Oregon National Primate Research Center at Oregon Health & Science University (OHSU) in Portland. The scientists were funded with a $7.2 million grant from NIAID, awarded in 2009. The new vaccine is being tested in a phase I clinical trial at Duke University in Durham, North Carolina, one of NIAID’s Vaccine and Treatment Evaluation Units (VTEUs).

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Catabasis Pharmaceuticals receives FDA Fast Track for CAT-1004

Wednesday, July 8, 2015 11:14 AM

Catabasis Pharmaceuticals, a clinical-stage drug development company built on a pathway pharmacology technology platform, today announced that CAT-1004 has received Fast Track designation from the FDA for the treatment of Duchenne muscular dystrophy (DMD). CAT-1004 is designed to inhibit activated NF-kB, which has the potential to reduce muscle inflammation and degeneration, and promote muscle regeneration for patients with DMD regardless of the underlying mutation. DMD is a rare disease that involves progressive muscle degeneration that eventually leads to death and for which there are no approved therapies in the U.S.

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Evotec, Roche provide initial update from phase IIb trial in Alzheimer's disease

Wednesday, July 8, 2015 11:12 AM

Evotec was updated by its partner Roche on the initial results of the phase IIb trial with Sembragiline (RG1577, EVT302), a MAO-B inhibitor for the treatment of Alzheimer's disease (AD). In this study, Sembragiline failed to demonstrate benefit on the primary endpoint (Alzheimer's Disease Assessment Scale—Cognitive Behaviour Subscale, ADAS-cog-11) after 52 weeks of treatment.

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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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