The White House laid out several timelines Oct. 18 as part of a national biodefense strategy for countering biological threats and enhancing global pandemic preparedness.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Heartflow, Proteomedix, SQI Diagnostics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Biogen, Decibel, Eureka, GSK, Kira, Mereo, Minerva, Telix.
Differences in individual responses to COVID-19 vaccines have been linked directly to different human leukocyte antigen (HLA) alleles and it has been shown that people carrying one specific variant, HLA-DQB1*06, generate higher antibody responses and are better protected from SARS-CoV-2 infection.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acorda, Alkermes, Amgen, Day One, Evotec, Kineta, Merck & Co., Moderna, Qu.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aligos, Alterity, Bio-Thera, Bridgebio, Immune-Onc, Moleculin, Nuance, Verona, Xbiotech..
Anti-SARS-CoV-2 monoclonal antibody (MAb) pair COV2-2196 (tixagevimab, class I) and COV2-2130 (cilgavimab, class III) are human neutralizing Abs (nAbs) that target nonredundant, complementary epitopes within the receptor binding domain of SARS-CoV-2 spike protein (S-RBD).
Nanoviricides Inc. has completed its IND-enabling preclinical drug development tasks pertaining to NV-CoV-2 for the treatment of SARS-CoV-2 infection and is working to prepare an IND application to submit to the FDA.
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