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Regulatory actions for Oct. 8, 2020

Oct. 8, 2020
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.
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Other news to note for Oct. 8, 2020

Oct. 8, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abveris, Aegle, Almirall, Ampio, Astrazeneca, Bayer, Betterlife, Biontech, Bristol Myers Squibb, Celgene, Cellgenix, Chromadex, Corneagen, Cytovia, Evotec, Gilead, Goldfinch, ILC, Immunitas, IMV, Intec, INSERM, Invetech, Johnson & Johnson, Kineta, Knopp, Lilly, Makana, Marinomed, Merck, Moderna, Nordic, Oblique, Oligomerix, Orbis, Pfizer, Recombinetics, Redhill, Rentschler, Roche, Santen, Seagen, Sorrento, Sumitomo, Sunovion, Translate Bio, Treefrog, Urovant, Vincera, Virtrial, Willow.
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In the clinic for Oct. 8, 2020

Oct. 8, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amgen, Caladrius, Cassiopea, Cytokinetics, Daiichi, Impel, Jazz, Merck, Moderna, Napajen, Noxopharm, Ocular, Opko, Pfizer, Philogen, Servier, Viiv.
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Microscope and coronavirus illustration

Stenzel says FDA will no longer review LDTs under EUA for COVID-19 pandemic

Oct. 7, 2020
By Mark McCarty
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.
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CEO holding Febridx

Lumos Diagnostics nabs $17.9M for rapid POC test

Oct. 7, 2020
By Meg Bryant
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.
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Coronavirus and coins
2020 Medical Innovation Summit

Panelists address challenges related to health care investment in the wake of COVID

Oct. 7, 2020
By Liz Hollis
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.
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