In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant and clinically meaningful cuts in low-density lipoprotein cholesterol levels. The PCSK9 inhibitor is looking to fit into a crowded market that already has well-established therapies from other big pharmas and a potential competitor in development to treat another indication.
Microneedle technology could help simplify vaccine delivery to better support global immunization efforts, and Australia is leading the way in this innovative technology.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Avadel, Formycon, Hutchmed, Innovent, Sydnexis, Telix, Tempest, Vigeneron.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alvotech, Basilea, Casma, Cullinan, Dr. Reddy’s, Genrix, Harmony, Immunoprecise, Lupin, Neurop, Ocugen, Pincell, Pfizer, Scinai, Seyltx.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Corcept, Duality, Immunic, Maia, Novartis, Regenxbio.