Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Astrazeneca, Iveric, Medincell, Moderna, Sanofi, Teva.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Ascentage, Bioatla, Biomind, Biontech, Laurent, NGM, Pfizer, Rain, Redhill, Vicore.
Formycon AG has published preclinical in vivo results for the development of its COVID-19 drug FYB-207. In in vivo studies, data were collected in two different models on the pharmacokinetics and efficacy of various constructs of the ACE2-Fc fusion protein, in order to select the most appropriate candidate to enter the clinic.
Results from a study carried out by the COVID-19 Host Genetics Initiative show that rare deleterious variants in the immune-system gene TLR7 make carriers more than five times more likely to have a severe SARS-CoV-2 infection. The TLR7 gene encodes Toll-like receptor 7 protein, which plays a protective role in the immune system by identifying pathogens and activating innate immunity.
While weekly global and U.S. confirmed cases of COVID-19 are below each of the last two years, infectious disease experts remain on guard. There are still about 1,500 people dying around the world each day, including 350 in the U.S., and the SARS-CoV-2 virus may continue to find ways to outmaneuver current treatments and vaccines.
CSL Ltd. subsidiary CSL Seqirus signed a licensing and development deal with Arcturus Therapeutics Inc. to in-license Arcturus’ late-stage self-amplifying mRNA vaccine platform technology. Arcturus will receive $200 million up front and is eligible to receive more than $1.3 billion in development milestones and over $3 billion in commercial milestones. In addition, it could capture a 40% net profit share for COVID-19 vaccines and up to double-digit royalties for vaccines against flu, pandemic preparedness and three other respiratory pathogens.
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