Biosimilars are bearing the brunt of the impact that COVID-19 has had on the U.S. FDA’s inspection program, which has ground almost to a halt during the pandemic. That’s the message Juliana Reed, president of the Biosimilars Forum, delivered to a House subcommittee last week.
More than 100 million people worldwide are thought to have post-acute COVID-19 syndrome, roughly 40% of everyone on the planet who’s had COVID. Now, thousands of them are beginning to cycle through clinical and preclinical studies designed to get a better look at this little understood aspect of the pandemic.
Studies published this week have introduced a consensus-based definition of long COVID-19 in children and young persons, narrowing its prevalence estimates, which have been wildly divergent. Long COVID rates for adults are still unclear, but a recent meta-analysis estimated that between one third and two thirds of adult COVID-19 patients who had severe acute disease develop symptoms of long COVID.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Active, Adial, Appili, Aptevo, Argobio, Biomarin, Bridge, Cold Spring Harbor, Cyclica, Cytovation, Edigene, Eli Lilly, Foundation, Gain, Hummingbird, IGM, Immunome, Laboratorio Libra, Luye, Model Medicines, Moderna, Neukio, Oncode Institute, Oncodesign, Perturba, Purnovate, Saptalis, Sengine Precision Medicine, Siolta, Teva, Trestle, Zucara .
While a number of U.S. cities and towns have been conducting wastewater testing for the SARS-CoV-2 virus for some time, the CDC has finally established a dashboard for reporting the results of this surveillance. While the resulting data may be useful in the current pandemic for allocation of resources, the establishment of a network of wastewater surveillance instruments can also be instrumental in future public health efforts, such as tracking foodborne infections and detecting the emergence of new antibiotic-resistant pathogens.
Xanadu Bio, a Yale University spinout developing an intranasal SARS-CoV-2 mRNA vaccine booster, has secured an exclusive license from the school for a polymeric nanoparticle delivery platform to support the project. The delivery tech could potentially have future applications for influenza, respiratory syncytial virus and even cystic fibrosis.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Azurity, Biogen, Celltrion, Everest, Gilead, GW, Jazz, NGM, Obseva, RDIF, Sanofi, Sinomab.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arbor, Askbio, Bayer, Biogen, Edigene, Healx, Merakris, Merck, Orange Grove, Ovid, Ridgeback, Touchlight, Xbrane.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Active Biotech, Actuate, Acurx, Antengene, Biomarin, Canbridge, Eubiologics, Evelo, Lysogene, Maplight, Nanoscope, Neoimmunetech, Pop, Tearclear, Uniqure.
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