Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 7 Hills, Acadia, Altamira, Antengene, Bayer, Biomind, C4, Merck & Co., Orion.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adiso, Aeterna, Astellas, Calcimedica, Cellevolve, Cerveau, Cipher, Depymed, Domain, Erasca, Explicyte, Genetic Leap, Lilly, Roche, Sun.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim Immunotech, Amryt, Denali, Freeline, Hansa, Novamind, Pfizer, Sobi.
The Biden administration sees the $15.6 billion just provided by Congress as inadequate funding for the pandemic, particularly given the administration’s new test-to-treat initiative, and will continue to press Congress for the remaining $6.9 billion requested by the White House, said Tom Inglesby, senior advisor for the White House COVID response team, at the American Clinical Laboratory Association annual meeting.
Sense Biodetection Ltd. is preparing to launch a new rapid, disposable, point-of-care molecular diagnostic test for COVID-19 in Europe after securing CE marking for the platform. The company will make its Veros COVID-19 test available in Ireland, Benelux and Nordic countries this quarter before expanding to other European markets.
With the pandemic lingering across the world and more COVID-19 therapies becoming available and in demand, the opportunity for counterfeits is growing.
An analysis of brain scans of participants in the UK Biobank has shown there are significant differences between the condition of the brain before and after mild COVID-19 infection. These included a reduction in overall brain size, reduction in grey matter thickness in the orbitofrontal cortex and hippocampal gyrus, and changes in markers of tissue damage in regions functionally connected to the primary olfactory cortex. Infected participants also showed, on average, a larger cognitive decline than participants who had not contracted COVID-19.
Shionogi and Co. Ltd. is looking to become the first company to get approval for a COVID-19 treatment under Japan’s conditional approval system as it prepares a phase III trial for S-217622 (ensitrelvir), its oral antiviral drug for COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Quotient, Saluda Medical, Sense.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Clinithink, Fox Biosystems, Harald AI, Heartbeat Health, Immunovia, Katalyst Diagnostics, Macatt Medica, Pixcell, Vygon.
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