The U.S. FDA’s stated policy is that it will not review emergency use authorizations (EUAs) for lab-developed tests (LDTs) for the COVID-19 pandemic, but that doesn’t mean labs are completely shut out. The FDA’s Toby Lowe said that a lab that wants to pair an assay that already has an EUA with a new software installation on lab instrumentation can work with the assay developer to update that EUA.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied UV, Axsome Therapeutics, Clinical Laserthermia Systems, Digirad, Electromedical Technologies, Energetic Wellness School of Naturopathy, The Feinstein Institutes for Medical Research, Mimedx, Novan, Ontrak, Stryker, Thermo Fisher Scientific, Toyoda Gosei, Wright Medical Group.
Keeping you up to date on recent developments in orthopedics, including: New opportunities for detecting osteoporosis; Brazilian researchers discover how muscle regenerates after exercise; Different outcomes by race/ethnicity among patients with COVID-19 and rheumatic disease.
HONG KONG – Humanigen Inc. has executed its first licensing agreement in the Asia-Pacific region, in a deal worth up to $20 million that gives Telcon RF Pharmaceutical Inc. and KPM Tech Co. Ltd. the development and commercialization rights to lenzilumab for COVID-19 in South Korea and the Philippines.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axsome, Bristol, Equillium, Generex, Ionis, Jubilant, Myokardia, Novan, Novavax, Ocular, Pfizer, Prothena, Salliant, Sofie.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA announces recall of discontinued Medtronic catheter.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Biolytical Laboratories, DNA Genotek, Pari Pharma, Salvia Bioelectronics.
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