PERTH, Australia – CSL Behring Australia, a subsidiary of CSL Ltd., will begin developing an anti-SARS-CoV-2 plasma product to treat people with serious complications of COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Caption Health, Cardiofocus, Cytosorbents, Helius Medical Technologies, Optiscan Biomedical, Ortho Clinical Diagnostics, Thermo Fisher Scientific, Transit Scientific.
DUBLIN – The Innovative Medicines Initiative (IMI), a public-private research partnership between the European Commission (EC) and Europe’s pharmaceutical industry, has boosted funding for a fast-track response to the COVID-19 pandemic from €45 million (US$48.8 million) to €72 million.
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.
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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpha Software, Aptar, Atrion, Beroni, Bioreference Laboratories, Cryolife, Fullerton Health, Guardant Health, Helius Medical Technologies, Livinguard, Opko Health, Orthofix, Twist Bioscience, United Health Products.
Several companies have reported quarterly results over the past couple of days, and those offering testing for COVID-19 have seen impressive numbers. Standing out was San Diego-based Quidel Corp., whose numbers caught the attention of William Blair’s Brian Weinstein. Indeed, its $174.7 million in revenue far exceeded his organization’s estimate of $160 million, driven by influenza.
