The FDA issued an advisory about the use of thermal imaging systems as screening instruments for the COVID-19 pandemic landing the same day as a warning letter to Certify Global Inc. The agency’s concern is that these systems are being used without consideration for the limitations, including that they are not appropriate for mass screenings due to inaccurate findings that could elevate the risk of spread of the SARS-CoV-2 virus.
PERTH, Australia – Genetic Technologies Ltd. signed a co-exclusive licensing deal with U.S.-based central lab Infinity Biologix LLC (IBX) for the production, sale and distribution of Genetic Technology’s COVID-19 serious disease risk test in the U.S. Branded as Genetype, the genotyping test combines a patient’s clinical profile with their genetic information to compute a patient’s risk of developing severe disease from COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Illumina, Second Sight.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Betta, Kintor, Moderna, Ocular, Roche, Seqirus, Sigilon, Turnsole.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aft, Alx, Fauna, Hyloris, Immune Regulation, Jaguar Health, Keros, Nanobiotix, Pharmaengine, Revolo, Seagen, Sumitomo, Tallac, Twoxar.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apellis, Aerpio, Bergenbio, Bioeclipse, Brii, Can-Fite, Eli Lilly, GT, Immutep, Longeveron, Macrogenics, Ocuphire, Seelos, Tersera.
A bad patient experience with telehealth can blunt adoption regardless of the incentives for developers and doctors. Griffin Mulcahey, chief compliance officer at Wheel Health Inc., of Austin, Texas, said during a recent webinar that users of these digital health apps and telemedicine programs may need assistance to get up to speed on an application, a critical effort that may make the difference between success and failure in telehealth.
CAJICA, Colombia – Cuba’s Center for the State Control of Drugs, Equipment and Medical Devices gave the green light March 3 for phase III trials of a domestically developed COVID-19 vaccine candidate, even though very little peer-reviewed information has been published about it.
The latest global regulatory news, changes and updates affecting biopharma, including: Australia eases substitution requirements; Guidance details fast-tracking modified vaccines.
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