The FDA’s response to the COVID-19 pandemic has been matched by device makers, but the ID Now molecular test by Abbott Park, Ill.-based Abbott Laboratories has been the target of recent criticism. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, said at a May 20 town hall meeting that Abbott has agreed to yet another study of the ID Now, the terms of which were under negotiation at the time of the meeting.
Proscia Inc., a Philadelphia-based company that focuses on artificial intelligence (AI)-enabled digital pathology solutions, recently made the Concentriq Dx digital pathology software available for use in reviewing and reporting of digital pathology slides in the U.S. during the COVID-19 pandemic.
Rapid Micro Biosystems Inc. scooped up $120 million in a series C financing led by Ally Bridge Group, with participation by Endeavor Vision and existing investors Bain Capital Life Sciences, Longitude Capital, Xeraya Capital and Asahi Kasei. The Lowell, Mass.-based company has earmarked the funds to expand the global footprint of its contaminant testing platform for biopharmaceutical and vaccine manufacturing and for new product development.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Aetion, Boston Scientific Neuromodulation, Nevro.
Atea Pharmaceuticals Inc., of Boston, brought in a $215 million series D financing to support development of its COVID-19 antiviral, which is designed to inhibit the viral RNA polymerase enzyme, a key element in RNA virus replication.
Saying it’s too early to gauge the potential economic benefit of a marketed COVID-19 therapy for his firm, Aldeyra Therapeutics Inc. CEO Todd Brady cited “a strong feeling of altruism” among researchers addressing the crisis, as they turn over discoveries likely to be helpful beyond it.
DUBLIN – Kancera AB is the latest contender to reposition a clinical-stage small molecule with an immunomodulatory mechanism as a drug candidate for COVID-19.
LONDON – Heart disease is now known to be both a cause and an effect of serious COVID-19 infection, with more than 1 in 10 patients who have underlying cardiac conditions being killed by the virus, while others with no previous record of cardiovascular problems are suffering significant COVID-19 induced weakening of their hearts.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Atea, Eiger, Evoke, Fate, Foundation, Incyte, Karyopharm, Merck, Morphosys, Octapharma.
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