Coronavirus - Articles - Page 363

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.

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.

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.

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.

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.

Surgeon at workstation for surgical robot

Virtual Medtech Conference

The future of robotic-assisted surgery looks bright despite COVID-19

Oct. 7, 2020

By Mary Ellen Schneider

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.

Regulatory actions for Oct. 7, 2020

Oct. 7, 2020

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic.

Other news to note for Oct. 7, 2020

Oct. 7, 2020

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 20/20 Bioresponse, Adm Tronics Unlimited, Ambu, Anpac Bio-Medical Science, Capillary Biomedical, Cb2 Insights, Decipher Biosciences, lectromedical Technologies, Ellume, Evicore Healthcare, Exact Sciences, Exonbio, Imagin Medical, Imed Surgical, Lequest, Lighthouse Imaging, Maverick County Medical, Medicine Discovery Catapult, Integrated Health, Oncimmune, Oncomfort, Origin, Orthex, Orthopediatrics, Paley Orthopedic and Spine Institute, Pfizer, Polarean Imaging, Philips, Qosina, Quanterix, Resolution Medical, Sonic Healthcare, Squadron Capital, Synthace, Todos Medical, Ubiquitome, Vygon.

In the clinic for Oct. 7, 2020

Oct. 7, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Medmira, Pulse Biosciences.

Lilly seeks EUA for COVID-19 antibody treatment

Oct. 7, 2020

By Michael Fitzhugh

With an ongoing phase II trial showing that a pair of its SARS-CoV-2 neutralizing antibodies has so far reduced viral load, symptoms and COVID-19-related hospitalization and ER visits, Eli Lilly and Co. has asked the FDA to consider an emergency use authorization (EUA) for one of the components, LY-CoV555.