Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter International, Diazyme, Infervision, Therapixel.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Accelmed Partners II, Alivecor, Applied DNA Sciences, Army Distaff Foundation, Boxview, Ekso Bionics, Henry Schein, Immunicom, Integragen, Lawrence J. Ellison Institute for Transformative Medicine, Lgc, Medpod, Myomo, Native Antigen, Neurometrix, Omron Medical, OncoDNA, Oracle, Osi Systems, Sectra, Sheba Medical Center, Spacelabs Healthcare, Stewart Industries, Tearlab, Visualdx, Yabao Pharmaceuticals.
Keeping you up to date on recent developments in diagnostics, including: Diagnosing fatty liver disease; Assessing COVID-19 with lung ultrasound; Noncoding mutations contribute to heart disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allergy, Anaptysbio, Assembly, Astrazeneca, Chemocentryx, Crinetics, Fate, Fujifilm, Immodulon, Leo, Merck, Mylan, Osmotica.
DUBLIN – Osivax SAS has assembled a public funding package of more than €32 million (US$36.3 million) to pursue ongoing clinical development of its universal flu vaccine and to take forward a coronavirus vaccine program based on a similar approach, involving vaccine-like particle (VLP) technology.
Plymouth, Minn.-based Nonin Medical Inc. gained a U.S. FDA 510(k) clearance for its Co-Pilot wireless hand-held multiparameter system (H500). The system is expected to be used by first responders to evaluate various oxygenation and respiratory-related parameters in patients after incidents such as cardiac arrest, traumatic injury, carbon monoxide or smoke inhalation.
The U.S. FDA’s priorities for testing for the SARS-CoV-2 virus have shifted as circumstances have changed, and the agency is putting more emphasis into testing of pooled samples. Toby Lowe, the associate director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said on the July 8 diagnostic town hall that the agency wants to encourage test developers to work on their existing EUAs for pooled sampling.
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