LONDON – A third COVID-19 vaccine has turned in positive results in the phase III interim analysis, with Astrazeneca plc/Oxford University reporting an average of 70.4% efficacy across two dose regimens for AZD-1222.
In what the FDA calls “an incremental step” in treating hospitalized COVID-19 patients, the agency has issued an emergency use authorization (EUA) for Eli Lilly and Co.’s baricitinib in combination with remdesivir.
Citing a lack of evidence that it improves survival, the need for ventilation or time to clinical improvement, the World Health Organization (WHO) has advised doctors against using Gilead Sciences Inc.’s antiviral Veklury (remdesivir) to treat COVID-19.
In a world more familiar with the 30% to 70% efficacy rates of seasonal flu vaccines, news of 95% efficacy rates for two of the major late-stage COVID-19 vaccines in development seems thrilling. But do such robust-sounding numbers, the product of relatively early analyses, really merit the enthusiasm they’ve garnered?
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, Alexion, Amgen, Astrazeneca, Beigene, Biontech, Eli Lilly, Gilead, Immupharma, Pfizer.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aptevo, Black Diamond, Coimmune, F-star, GSK, Immunomic, Mannkind, Matinas, Metavant, Metuchen, Neurotrope, Petros, Poxel, Sosei, Spring Bank, Sumitomo, United, Vectura.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amarin, Clear Creek, Glycostem, Inovio, Marinomed, Redhill.
PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.
LONDON – Phase II data on Astrazeneca plc’s AZD-1222 COVID-19 vaccine show it prompts an equivalent immune response in healthy people aged 70, to that seen in people ages 18 to 55, despite the fact the elderly had fewer side effects from vaccination.
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