Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bristol Myers Squibb, H. Lundbeck, Moderna, Otsuka, Pfizer, Rnaimmune, Senhwa.
Rnaimmune Inc., a nonwholly owned subsidiary of Sirnaomics Ltd., has received clearance from the FDA for its IND application to conduct a phase I trial for RV-1730, a SARS-CoV-2 vaccine booster candidate.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arbutus, Atea, GSK, Hipra, In8bio, Invivyd, Myrtelle, Santhera, Stoke, Tarsier, Virios.
As it requested, the U.S. FDA got an earful April 25 as people with long COVID and their caregivers shared their experiences with the condition that has no approved, or even authorized, treatment and is not that well understood, given its range of symptoms that vary from person to person.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achieve, Beigene, Bioinvent, Cantex, Dare, Maia, Promore, Sellas, Visus.
While the pandemic is nearing its end, Chinese officials are calling for the development of novel, multivalent COVID-19 vaccines as an essential task moving forward. To date, China has 17 COVID-19 vaccine products that have completed or are in phase III trials, according to the NMPA.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Direct, Everest, Finch, Keyuan Xinhua, Maxion, Nona, Shanghai, Sinopia.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, Alzamend, Alzheon, Anixa, Arch, Autobahn, Biolinerx, Clearside, FSD, Lisata, Madrigal, Merus, Nova Mentis, Plus, Renovion, Sellas, Technoderma.
The latest U.S. FDA emergency use authorizations to fall by the wayside, as COVID-19 continues to evolve, are the ones for the first Moderna Inc. and Pfizer Inc.-Biontech SE’s mRNA vaccines.
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