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In the News: October Regulatory and Development Updates

Camargo

In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. Manager of Regulatory Compliance. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc. Co-Authors: Jenny Fielder.

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How Potential Changes to the NIH Guidelines Could Impact IBC Review

WCG Clinical

Although the NIH Guidelines were originally written with non-clinical laboratory research in mind, they also apply to human gene transfer (HGT) research, wherein rsNA or rsNA-containing products are administered to research participants. Since then, however, certain genetic engineering technologies (e.g.,

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Biorepositories as a Guiding Resource for Research & Drug Discovery

XTalks

The power of leveraging clinical data to decipher disease mechanisms and fuel drug discovery has rapidly grown in the era of genomics and personalized medicine. Genuity Science focuses on population genomics as a tool to derive novel biological insights through partnerships with industry-leading pharmaceutical and biotech companies.

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AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

The Pharma Data

AstraZeneca has developed a broad range of technologies, initially focused on small molecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. More recently, AstraZeneca has increased its efforts in immunology research and the development of medicines for immune-mediated diseases.

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Informed Consent Writing Tip Sheet

Advarra

regulatory agencies recommend written ICFs contain easy-to-read and understandable information so a lay person can make an informed decision about participating in a study. For research regulated by the Common Rule: For research involving biospecimens , whether the research will (if known) or might include whole genome sequencing.

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Athersys Announces Three Appointments to Board of Directors

The Pharma Data

a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. She currently serves as a non-executive director on the board of Genfit, S.A., Before joining Acorda, Ms.

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Bristol Myers Squibb Reports Second Quarter 2020 Financial Results

The Pharma Data

FDA for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. The information contained on, or that may be accessed through, our website or social media channels are not incorporated by reference into, and are not a part of, this document.