Using CRISPR to turn cancer cells against themselves
July 17, 2018
By Neozene

Taking healthy immune-boosting T cells from patients and engineering them to recognize and kill cancer is a well-established approach now, with the success of Gilead’s Yescarta and Novartis’ Kymriah. But researchers at Brigham and Women’s Hospital have a different idea for creating cancer-killing cells—and it involves modifying tumor cells instead of T cells. The team is using CRISPR gene editing to modify cancer cells so they can home in on tumors and deliver therapies to them. So far, they’re getting promising results in animal models of breast and brain cancer,

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First clinical MERS vaccine by Inovio and GeneOne shows promise
July 11, 2018
By Neozene

Inovio and GeneOne Life Science’s MERS vaccine, which is receiving financial support from the International Vaccine Institute (IVI) and the Coalition for Epidemic Preparedness Innovations (CEPI), elicited high levels of antibodies and T-cell responses in a phase 1 study. Overall, 94% of subjects injected with the MERS vaccine candidate, dubbed INO-4700 or GLS-5300, showed antibody responses two weeks after their third dose, according to the partners. Investigators observed broad-based T-cell responses in nearly 90% of participants. In the phase 1 trial, conducted by the Walter Reed Army Institute of Research

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US Regulators Propose Expanded Medical Device Cybersecurity Approach
May 1, 2018
By Neozene

The US Food and Drug Administration is considering several new measures to address medical device safety and cybersecurity, including a new public-private coordinating board to evaluate high-risk, high-impact connected devices. The cybersecurity and related measures make up the agency’s new Medical Device Safety Action Plan, developed to focus also on issues including streamlined post-market processes; foster innovation to boost device safety; and merge the Center for Devices and Radiological Health’s (CDRH) premarket and post-market branches to advance a “Total Product Lifecycle” or TPLC approach to device evaluation and oversight. Cybersecurity

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