The latest global regulatory news, changes and updates affecting biopharma, including: Health Canada explains COVID-19 disclosures; TGA on changing sponsor details; FDA awards research grants for rare diseases; Se habla español.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerecin, Eton, Neurocrine, Regeneron, Revelation, Rhythm AI, X4, Xenon, Xortx.
The U.S. FDA will no longer review lab-developed tests (LDTs) for the SARS-CoV-2 virus under the emergency use authorization (EUA) program, a change that will eliminate any prospect of immunity from liability for these tests. The FDA’s Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, announced the news on the weekly COVID-19 testing town hall, but the change was simultaneously unveiled in the FDA’s Q&A for testing.
Lumos Diagnostics Holdings Pty. Ltd. scooped up AU$25 million (US$17.9 million) in an oversubscribed pre-IPO ahead of its anticipated 2021 listing on the Australian Securities Exchange (ASX). The funds will be used to expand manufacturing operations in California and Florida and to grow the commercial footprint of Febridx, a rapid point-of-care (POC) test that can determine if a person has a viral or bacterial infection within 10 minutes.
The ongoing pandemic brought about several challenges for investors looking for the next big thing, but some areas still have experienced growth. Experts addressed this topic and other issues during a panel discussion Tuesday at the Cleveland Clinic’s 2020 Medical Innovation Summit. Moderator Lydia Ramsey Pflanzer, health care editor, Business Insider, highlighted a bright spot, noting that by the end of the third quarter, digital health startups were doing well, raising $9.4 billion, according to Rock Health.
The COVID-19 pandemic has been a bump in the road for developers of digital surgical systems that include robotics, but the technology is still in demand. That was the message from industry leaders at the Advanced Medical Technology Association’s Virtual Medtech Conference.
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