Clinical updates, including trial initiations, enrollment status and data readouts and publications: Galderma, Galera, Gamida, Genfit, Glenmark, Marker, Minoryx, Neurana, Ocular Therapeutix, Rocket, Sanofi.
The U.S. FDA has issued an emergency use authorization (EUA) for an antigen test for the SARS-CoV-2 virus from Quidel Corp., of San Diego, that is more readily deployed than other diagnostic tests for the pathogen. Quidel’s offering can be used at the point of care (POC) and as a lab test.
The U.S. FDA has expanded the emergency use authorization (EUA) for Rutgers University’s saliva-based COVID-19 test to include at-home use of Spectrum Solutions LLC’s SDNA-1000 whole saliva collection device, a development that underscores the need for wider testing as localities across the country emerge from lockdown and restart their economies. This is the first at-home option for saliva collection; the action comes just two weeks after the FDA authorized Laboratory Corp. of America’s polymerase chain reaction test for SARS-CoV-2, the virus that causes COVID-19, to include the company’s Pixel self-collection kit for nasal samples.
HONG KONG – Blockchain technology usually is associated with digital currencies. However, it’s now emerging as an important platform for COVID-19 management. It’s been a focus in China, where a top-down approach is key to driving sectors and technology.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accelmed, Aidoc, Avita Medical, Bellerophon Therapeutics, Datametrex AI, Fresenius Medical Care North America's Renal Therapies Group, Gaia, Inspire Medical Systems, Kc Wearable, Mevion Medical Systems, Orexo, Perkinelmer, Quest, Rochal Industries, Sanara Medtech, Seevix, Tearlab, Technopath, Telemedicine Clinic, Tissue Regenix, Unilabs, Zoll.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Aspenstate, Elemaster, Myriad, Visioncare.
After being hit with the major financial market meltdown when the COVID-19 outbreak decimated U.S. capital markets during March that saw the valuations of public biopharmaceutical companies developing new medicines plummet, it appears that they have put that reversal behind them with a dramatic price surge in April.
Having a COVID-19 therapy approved through an emergency use authorization (EUA) is not the same as having access to it, even if it’s free. Accounting for one-third of the nearly 4 million COVID-19 cases confirmed globally as of Monday and 28.5% of the 278,957 deaths, the U.S. is getting 40% of the 1.5 million vials of remdesivir Gilead Sciences Inc. is donating worldwide.
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