Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic, Masimo, Quotient, Zymo Research.
With only days left before Inovio Pharmaceuticals Inc. planned to initiate a phase II/III trial of its COVID-19 DNA vaccine candidate, INO-4800, and its accompanying delivery device, the FDA placed a partial clinical hold on the company’s study. This is the study’s second delay as the company originally planned to begin in July or August. November is now the earliest potential start date. Inovio told BioWorld that the company and its partners are continuing to prepare for the phase II/III trial “following resolution of the FDA’s partial clinical hold.”
Wellington Life Sciences general partner Regina Hodits, during a talk with CBT Advisors CEO Steve Dickman at the recent Biopharm America meeting, said the disaster scenario feared for European investments when COVID-19 struck “turned out very different. We never have a lot of time off in summer, not as much as we would want to, but this year we certainly had no time off,” as portfolio firms found money and Wellington tapped new opportunities.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aligos, Apollomics, Aquestive, Avrobio, Biomed Valley, Cipla, CSL, FSD, Gilead, Glaxosmithkline, Heron, Huya, Inceptua, Inovio, Khondrion, Orchard, Shionogi, Stemedica, Xcures.
A team of scientists at Duke Health has identified biomarkers that accurately detect viral infections before a person becomes symptomatic. The findings were published in The Lancet Infectious Diseases.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Songbird Life Science, Starfish Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Artificial Intelligence Defense Platform, Axonics, Biovica, Bose, Establishment Labs, Lambdavision, Medtronic, Nexstim, Puregraft, Space Tango, Todos Medical.
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