Global Medical Device Regulatory Trends: Traceability, Simplified Market Access
July 31, 2018
By Neozene

In the past half year (January through June 2018), Emergo has observed data to support two global trends: Initiatives to enhance device tracking and traceability, and simplification of the regulatory process for the lowest-risk medical devices. Periodically, we review all the global regulatory updates and changes for global trends. These are Emergo’s observations, fueled only by review of regulatory current events (and perhaps a few large cups of coffee). And, our analysis and assessment of them. We should also acknowledge that the International Medical Device Regulators Forum (IMDRF) has been working

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Immune responses from Johnson & Johnson’s ‘mosaic’ HIV shot last 1 year: study
July 24, 2018
By Neozene

Pressing ahead with its “mosaic” HIV vaccine, which aims to guard against viral subtypes worldwide, Johnson & Johnson reports that its regimen elicited immune responses that lasted one year after vaccination in phase 1/2a study participants. In the Approach study, investigators found that all participants who received the lead vaccine regimen maintained an immune response one year after their final shots. The regimen consists of prime doses at weeks 0 and 12, plus booster doses at weeks 24 and 48. J&J presented the data Tuesday at the International AIDS Conference

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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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