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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kronos, Nervgen, Nicox, Novadip, Ocumension, Pfizer, RDIF, Regeneron, Sanofi.
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