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.

Hot on the heels of news that two vaccines for COVID-19 are nearing market readiness, two companies have broken away from the pack of assay manufacturers to offer quantitative antibody tests that can verify whether the vaccines provide effective, lasting protection. Siemens Healthineers and Imanis Life Sciences both claim to be first to develop scalable, quantitative neutralizing antibody tests.

Concerns about biopharma executives profiting from stock sales aligned with releases of promising COVID-19 vaccine results could result in Congress requiring a cooling-off period for executives’ 10b5-1 plans that provide a safe harbor to insider trading. Testifying in a Nov. 17 hearing before the Senate Banking Committee, SEC Chair Jay Clayton suggested a mandatory period of four to six months between implementing or materially changing a 10b5-1 plan and the first allowed stock sale. He added that the cooling-off period should at least cover a full quarter.

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.

Many of the developers of in vitro diagnostic tests will seek to convert their emergency use authorizations (EUAs) to conventional premarket filings, and Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said a draft guidance for this conversion is in process. However, Stenzel said he could not predict when that draft might emerge, given that the agency is still scrambling to keep up with both EUA and conventional applications.

Lucira Health Inc. has secured U.S. FDA emergency use authorization for the first prescription molecular diagnostic test for COVID-19 that can be performed from start to finish in the convenience of one’s home. The single-use, COVID-19 All-in-One Test Kit employs a simple ‘swab, stir and detect’ design that yields results within 30 minutes – enabling individuals who expect they have the virus to get results while isolating at home.