Ethics/Regulatory

Certara Strategic Consulting awarded GLP compliant toxicokinetic test site certification

Wednesday, February 22, 2017

Certara, a provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, has announced that the Standards Council of Canada (SCC) has awarded Good Laboratory Practices (GLP) certification to its Certara Strategic Consulting (CSC) Montreal facility. CSC Montreal has passed the requisite inspection and study audits and is now recognized as a GLP compliant Toxicokinetic Test Site by SCC.

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CRISPR, Intellia, Caribou and ERS Genomics provide update on CRISPR/Cas9 U.S. patent

Friday, February 17, 2017

CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences and ERS Genomics provided an update on the Patent Trial & Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO) decision on the motions filed by the University of California, the University of Vienna and Dr. Emmanuelle Charpentier (collectively, UC), on one hand, and the Broad Institute, Harvard University and the Massachusetts Institute of Technology (collectively, Broad), on the other, in the interference proceeding relating to CRISPR/Cas9 genome editing technology.

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Beaufort receives ISO 9001:2015 certification

Tuesday, February 14, 2017

Beaufort, a CRO and consultancy, has obtained ISO 9001:2015 certification. The certification demonstrates that Beaufort provides consistently good quality services to the life sciences industry in its clinical research, regulatory affairs, quality and staffing solutions.

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Report: Device tax cost medtech industry 29k jobs

Monday, February 13, 2017

The U.S. medical technology industry saw its jobs ranks fall by nearly 29,000 while the medical device excise tax was in effect, according to the latest figures from the U.S. Department of Commerce. Specifically, from 2012 to 2015, the number of U.S. medtech jobs declined from 401,472 to 372,638—a loss of 28,834 jobs or a 7.2% decrease for the time period.

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PixarBio investors launch lawsuit

Wednesday, February 1, 2017

Lawsuit for Investors in shares of PixarBio announced by Shareholders Foundation. The Shareholders Foundation lawsuit was filed on behalf of certain purchasers of shares of PixarBio over alleged Securities Laws Violations by PixarBio.

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Align Biopharma launched as industry standards group

Monday, January 30, 2017

Six of the top 25 largest global pharmaceutical companies announced the formation of Align Biopharma, a new group dedicated to setting technology standards that will make it faster and easier for healthcare professionals (HCPs) to connect with the life sciences industry. Founding members, with input from across the industry, will develop open standards and solutions for companies to streamline how HCPs get the drug and treatment information they need to deliver improved care to patients.

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Greenphire, Exostar partner on clinical research site payment solution

Friday, January 27, 2017

Greenphire, a global leader in clinical payment solutions, and Exostar, whose cloud-based solutions help companies mitigate risk and solve their identity and access challenges, have announced a partnership that facilitates the adoption, accessibility and use of clinical research site payment solutions. The partnership brings web-based Single Sign-On (SSO) functionality to Greenphire’s eClinicalGPS, creating seamless and secure access to the global clinical site payment platform.

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3E, Dotmatics partner on scientific informatics and environmental compliance

Wednesday, January 18, 2017

3E Company, a provider of environmental health and safety (EH&S) compliance and information management services, has announced a strategic alliance with Dotmatics, a provider of scientific informatics solutions and services to the life sciences industry. The alliance will offer Dotmatics and 3E customers access to a range of integrated applications designed to optimize scientific information management, chemical and formula risk analysis, environmental compliance and workplace safety while helping to streamline processes, reduce costs and increase efficiency. Having access to reliable and up-to-date scientific and regulatory information enables life sciences businesses to improve knowledge management, data storage and decision support. 3E Company is a Verisk Analytics business.

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