2017

Calling all clinical research personnel

Monday, October 23, 2017

The Pulse on Global Trials by Matthew Howes

In recent years, a global talent shortage has hampered strategic growth for many organizations. According to the ManPower Group, 36% of employers globally report talent shortages, the highest in seven years.

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Phase III Lusutrombopag study shows positive efficacy

Friday, October 20, 2017

Shionogi & Co. announced it will present positive efficacy and safety results from a global phase III study (L-PLUS 2) of lusutrombopag (S-888711), an investigational, once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist, at the 2017 American Association for the Study of Liver Diseases (AASLD) Liver Meeting to be held October 20-24 in Washington, D.C.

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FDA approves CAR-T cell therapy for large B-cell lymphoma

Friday, October 20, 2017

The FDA approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).

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AMRA, BioTelemetry partner on NASH/NAFLD clinical trials

Friday, October 20, 2017

AMRA, the international leader in body composition analysis, and BioTelemetry Research (BTR), a global imaging and cardiac core lab, announced the formation of an exclusive alliance for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) clinical trials. This first-to-market partnership will advance imaging science and benefit clinical trial sponsors in several musculoskeletal and metabolic therapeutic areas.

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Accenture joins Partnership on AI

Friday, October 20, 2017

Accenture has joined the Partnership on AI, an alliance of businesses, researchers, academics and policy makers that work to advance the understanding of artificial intelligence (AI) technology and develop best practices on the challenges and opportunities within the field. Accenture joins other prominent industry leaders who share its commitment to advancing the field of AI so that it benefits people and society. Accenture will actively contribute its own insights, research and capabilities in areas including Responsible AI, and will dedicate people and resources to collaborate with Partnership on AI members to help address important global challenges such as food, diversity, inclusion, health, education and economic opportunity.

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Institut Curie, Pierre Fabre Partner on immuno-oncology

Friday, October 20, 2017

Institut Curie and the IRPF (Institut de Recherche Pierre Fabre) will collaborate on new therapeutic strategies to advance cancer treatment for patients. The objective of this novel partnership is to dissect the biology of novel therapeutically tractable targets and evaluate the impact of innovative pharmacological approaches leveraging the Institut Curie’s biological models.

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WuXi AppTec acquires ResearchPoint Global

Friday, October 20, 2017

WuXi AppTec, a global pharmaceutical, biotechnology and medical device open-access capability and technology platform, has acquired ResearchPoint Global (RPG), a U.S.-based CRO with expertise spanning across all major therapeutic areas. Upon the closing of this acquisition, RPG will become a wholly-owned subsidiary of WuXi, and will continue to focus on growing its core competences and providing better clinical development services. The acquisition underscores a strategic step forward to expand WuXi’s clinical research capabilities in the U.S. and around the world, further strengthening WuXi’s integrated R&D capability platform.

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FDA grants Priority Review for Lynparza in metastatic breast cancer

Wednesday, October 18, 2017

AstraZeneca and Merck, known as MSD outside the U.S. and Canada, announced that the FDA has accepted and granted priority review for a supplemental New Drug Application (sNDA) for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated (gBRCA), HER2-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy either in the neoadjuvant, adjuvant or metastatic settings. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2018.

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