Congress Urges FDA to Better Scrutinize COVID-19 Antibody Tests
April 27, 2020
By Neozene

This article originally appeared in FierceBiotech and was written by Conor Hale Members of Congress have called on the FDA to re-evaluate its stance toward COVID-19 antibody tests. Since mid-March, the agency has allowed diagnostic developers to bring their products to market without any outside evaluation that the results they produce are accurate. Instead, these manufacturers can proceed after validating the tests themselves, but they are not required to share those results. Companies must also print labels saying their antibody tests are not FDA approved or authorized and should not be used

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‘Nano-Immunotherapy’ Halts Glioblastoma in Mice
August 29, 2019
By Neozene

This article originally appeared in FierceBiotech and was written by Arlene Weintraub One of the most difficult challenges in treating the brain cancer glioblastoma is that few drugs can pass through the blood-brain barrier. Scientists at Cedars-Sinai in Los Angeles have developed a system to circumvent this hurdle—one that combines a powerful immuno-oncology drug with a polymer-based delivery vehicle that can cross the blood-brain barrier. The researchers showed that this “nano-immunotherapy” treatment crossed the blood-brain barrier in mouse models of glioblastoma, and that it stopped tumor cells from multiplying. They

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FDA announces overhaul of medical device approval system
November 28, 2018
By Neozene

The FDA plans to overhaul the decades-old medical device approval system that has been criticized by experts for risky implants and failure to catch problems, it announced Monday. The decision comes one day after an investigation on global medical device safety was published by the International Consortium of Investigative Journalists (ICIJ) — with over 250 journalists from more than 50 organizations helping with the investigation. The investigation found more than 1.7 million injuries and almost 83,000 deaths may have been linked to medical devices over a 10-year period in the

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