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.
PT Etana Biotechnologies Indonesia secured a series B financing of undisclosed value, led by Chinese investors that include Jack Ma’s Yunfeng Capital and Highlight Capital. The funds will be used to strengthen the company's pipeline and to expand its local manufacturing capacity.
While biopharma grants and company deals with nonprofits and government entities have dropped below each of the last two years, the volume of activity for non-pandemic-related efforts has remained steady. A total of 837 biopharma-nonprofit deals and grants combined so far this year are worth $10.8 billion, which is down by 21.6% over last year’s $13.7 billion and by 15.6% over 2021’s 992 volume. Also down are the deals and grants focused on the COVID-19 pandemic.
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