As COVID-19 deaths across the globe top 3 million, with more than 1 million in Europe alone, the global demand is increasing for mRNA vaccines, even as sponsors of adenovirus vaccines push back against ongoing safety concerns. Last week, the World Health Organization’s (WHO) Regional Office for Europe reported that the confirmed COVID-19 death toll for the region had surpassed 1 million, with 1.6 million new cases being reported every week. More than 171 million doses of COVID-19 vaccines have been administered in the region, translating to nearly 13% of the European population receiving one dose and close to 6% completing both doses of the vaccines.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aegis, Alzecure, Bergenbio, Checkmate, Erytech, Humanigen, Lyndra, Medivir, Pharmabcine, Sirnaomics, Todos Medical, Transcenta, Ziopharm, Zyus.
Chicago-based public benefit corporation Neopenda LLC secured the CE mark for its wireless, wearable vital signs monitor and picked up $1.4 million in new funding led by Assiduity Capital and the Sorenson Impact Foundation. The organization developed Neoguard to monitor critically ill infants in resource-poor regions, but adapted it last year to meet the monitoring needs of adult patients with COVID-19. The CE mark approval covers adult, pediatric and neonatal patients.
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.
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