Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical, Hemanext, Lumiradx.
LONDON – The U.K. is moving on to the next phase of testing mixed dosing schedules for COVID-19 vaccines, launching a study in which it will assess the effect of using Moderna Inc. or Novavax Inc.’s products as the second dose in a heterologous prime boost trial.
LONDON – A large scale prospective study has shown that increased blood plasma viscosity is correlated with disease severity and the likelihood of progression to organ failure, in patients who are hospitalized with COVID-19 infections. Researchers at Addenbrooke’s Hospital in Cambridge, U.K. suggest this could be an easy but sensitive way to quickly triage patients admitted to hospital with symptoms of COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cosmo, Lucira Health, Masimo, Medtronic, Myhomedoc, Thermo Fisher Scientific.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angiodynamics, Avantor Performance Materials, Diasorin, Luminex, Mediphos Diagnostics Belux, Respicardia, Technomed, Zoll Medical.
CAJICA, Colombia – Following the start of phase III trials for its COVID-19 vaccine, Soberana 02, Cuban researchers have started phase III trials for Abdala (CIGB-66), another vaccine candidate developed in the island country.
The FDA has its hands full with the impact of the mutations to the SARS-CoV-2 virus, but test developers can count on an ever-increasing base of data for those viruses thanks to a new contract taken by the CDC. The CDC indicated recently that its sequencing efforts and that of other organizations churned out nearly 14,000 sequences for the week of April 3, but Aegis Sciences Corp., of Nashville, Tenn., announced April 7 that it had undertaken an agreement to perform next-generation sequencing of samples from all 50 states and Puerto Rico, ensuring plenty of access to up-to-date information on those mutations.
Hologic Inc. is tucking in yet another diagnostics manufacturer, this time with the acquisition of Mobidiag Oy for approximately $795 million. The privately held Finnish-French company develops and markets polymerase chain reaction (PCR)-based tests for acute care testing such as gastrointestinal and respiratory infections, antimicrobial resistance management and health care-associated infections.
