The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA says backlog of non-COVID applications will be cleared in eight weeks; NIH awards $33M for return-to-school efforts; Advamed tells CMS not to delay on MCIT.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Qorvo, Seigla.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch, Biogen, Chipscreen, Eli Lilly, Oncopeptides.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alexion, Amgen, Astrazeneca, Bold, Brooklyn Immunotherapeutics, Celularity, Factor Biosciences, Five Prime, Gigagen, Immutep, Novellus, Peptron, Portage, Qilu, Relay, ZebiAI, Zogenix.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biogen, EMD, Horizon, Implicit, Kintor, Merck KGaA, Quantum Leap, Roche, Takeda, TG.
Phase I data on immune responses induced by Inovio Inc.'s COVID-19 DNA vaccine candidate, INO-4800, showed it induced neutralizing antibodies and T-cell responses against all spike protein variants tested in a phase I study, including those first detected in the U.K., South Africa and Brazil. A preliminary report on the analysis, published on bioRxiv, preceded the reporting of phase II data on the candidate expected later this quarter as well as a potential move to phase III testing, pending resolution of a partial clinical hold on the study first announced in September 2020.
DUBLIN – A newly published retrospective analysis of the electronic health care records of more than 500,000 COVID-19 patients has found that infection with SARS-CoV-2 carries “a significantly and substantially” greater risk of cerebral venous thrombosis (CVT) than does either one of the two approved mRNA COVID-19 vaccines or infection with influenza virus.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Diurnal, Elsalys, Exelixis, Fibrogen, GSK, Illuminare, Kintor, Mitochem, Vir.
RSS
