Ethics/Regulatory

Western IRB establishes single-IRB solution

Tuesday, March 21, 2017

Western Institutional Review Board (WIRB), a provider of ethical review of clinical research, announced the launch of its WIRB NIH Single Review Solution (SRS) for NIH-funded multi-site research. WIRB has an extensive background in reviewing clinical trials funded by NIH. Building upon status as the IRB of record for the majority of institutions that conduct clinical research in the U.S., WIRB NIH Single Review Solution will provide participating institutions the gold standard of research review.   

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FDA, EU drug inspectors ink Mutual Recognition Agreement

Monday, March 6, 2017

The U.S. and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.

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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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