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.
Virtual care provider Doctor On Demand has scooped up $75 million in a series D round led by General Atlantic, with participation from existing investors. The funds are earmarked to fuel the company’s growth and expand access to comprehensive telehealth services across the U.S. Combined with earlier financings, the San Francisco-based company has raised nearly $240 million to date.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Balt, Nonin Medical, Saladax Biomedical, Urocam.
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