DUBLIN – The Lancet Infectious Diseases has published the first clinical data on BBIBP-CorV, an inactivated whole virus vaccine directed against SARS-CoV-2. The early stage phase I/II study tested the Chinese-developed vaccine in 540 healthy volunteers, including 96 older participants. All vaccine recipients seroconverted and the adverse event profile was mild.
Intervenn Biosciences said it has identified stark differences in the glycoproteomic profile of COVID-19 patients who became very sick and people infected with the SARS-CoV-2 virus who were either asymptomatic or experienced only minimal effects. The contrast could help clinicians better understand the biological mechanisms of the disease and triage patients at risk of responding detrimentally to early treatments and more intensive care.
LONDON – Oncimmune Holdings plc has won government funding to apply its autoantibody biomarker technology to develop a COVID-19 immune profiling tool for triaging patients and predicting response to therapies and vaccines in development against the virus. The company will cross reference serum samples from 3,000 COVID-19 patients against its library of 800 SARS-CoV-2 related antigens and peptides to identify autoantibodies that characterize the range of immune responses to the infection.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ac Immune, Alliance Family of Companies, Applied DNA Sciences, Battelle, Caretaker Medical, Cerner, Clinical Laserthermia Systems, Columbia University, DNA Labs International, Freedom Innovations, Haliodx, Induction, Medalliance, OSU Wexner Medical Center, Osmind, Ottobock, Pacific Edge, Paltown Development Foundation Proteor, Providence, Southwest Labs, Stratus, Tegria, Thermo Fisher Scientific, Votis.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cartiheal, GE Healthcare, Varian.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation; AMA adds codes for COVID-influenza testing; MedPAC concerned about post-pandemic telehealth; CMS: CLIA audits yield cease-and-desist letters.
LONDON – The first confirmed case of COVID-19 reinfection in the U.S. has been reported, with a patient testing positive for two distinct SARS-CoV-2 strains within 48 days, while testing negative in between contracting the two infections.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, Genmark Diagnostics, Oxford Nanopore.
