Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Hecin, Holista Colltech.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boston Scientific, Edevice, Genesis Medtech Group, Horcon, Inivata, Neogenomics, Pattern Computer, Predictmedix, Rakuten Medical, Shimadzu.
About a year-and-a-half after the sequencing of the SARS-CoV-2 virus and the onslaught of COVID-19 therapeutic and vaccine development that followed, the biopharma industry boldly tackles a slew of ongoing issues from vaccine hesitancy and supply inequities to the ramifications of a potential intellectual property waiver and the pressing need to prepare global systems for the next pandemic.
Diagnostics powerhouse Danaher Corp. has agreed to buy Aldevron LLC, a privately held biotech company that supplies a key ingredient for COVID-19 vaccines, from EQT VIII Fund for $9.6 billion in cash. Based in Fargo, N.D., with additional operations in Madison, Wis., Aldevron makes high-quality plasmid DNA, mRNA and recombinant proteins used in vaccines, gene and cell therapy, gene editing and diagnostic applications.
LONDON – Regeneron Pharmaceuticals Inc.’s antibody cocktail, Regen-Cov, has been shown to significantly reduce mortality in seriously ill hospitalized COVID-19 patients who have failed to mount their own immune response against the SARS-CoV-2 virus. Among these seronegative patients, the casirivimab/imdevimab monoclonal antibody mixture reduced deaths by 20% (p=0.001) in the U.K. Recovery trial.
New phase III data on Celltrion Inc.'s COVID-19 therapy, regdanvimab, showed it reduced the risk of hospitalization or death related to the disease for high-risk patients to 3.1% vs. 11.1% for placebo by day 28 of the study. The treatment also proved beneficial to participants across all risk categories, reducing their risk of hospitalization or death to 2.4% vs. 8% for placebo at the same time point.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kheiron Medical Technologies, Letsgetchecked, Liquiglide, Livanova.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Attralus, Bioprotect, Novadip, Proven Pharmaceuticals.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exthera Medical, Icad, Quidel.
