Biomedicine Weekly · Week 39, 2026 · 09.21 — 09.27

On this pageThe FDA approved Eli Lilly's once-weekly basal insulin efsitora alfa (Onswik) for adults with type 2 diabetes, announced September 24, 2026, to improve glycaemic control alongside diet and exercise. Efsitora is a fusion protein linking a novel single-chain insulin variant to a human IgG2-Fc domain, extending half-life so a weekly subcutaneous injection replaces daily dosing. China approved the drug as well. Expressed in CHO cells, the 299-amino-acid Fc-fusion protein has 24 disulfide bonds and a 64 kDa molecular weight; in QWINT-1 and QWINT-2 it showed glucose lowering non-inferior to insulin glargine and insulin degludec.

On this pageNovo Nordisk's CagriSema (cagrilintide plus semaglutide) beat tirzepatide 5 mg head-to-head on the primary endpoint of the phase III REIMAGINE 5 trial in adults with type 2 diabetes inadequately controlled on metformin or an SGLT2 inhibitor. The parallel phase III REDEFINE 9 study in obesity or overweight met its primary endpoint versus placebo. If approved, CagriSema would be the first GLP-1 plus amylin combination therapy worldwide. Meanwhile, China's NMPA approved a September 21 label update for Lilly's tirzepatide (Mufengda) adding SUMMIT data in obese HFpEF patients, showing a 38% reduction in risk of worsening heart failure.

On this pageThe FDA approved Ionis's antisense drug Zanvastro (zilganersen) for Alexander disease in children and adults on September 3, the first therapy for the disease and first directly targeting the causal protein's accumulation, three weeks ahead of its PDUFA date. On September 17 it approved Bayer's finerenone for chronic kidney disease associated with type 1 diabetes, the first new option in over 30 years. The same day, gene therapy FAYUVI was approved for MPS IIIA at a $3.95 million list price, tied for second most expensive drug in the world. On September 23, an FDA panel voted that GRAIL's Galleri multi-cancer early-detection blood test's benefits outweigh its risks.

On this pageRoche and Ionis's sefaxersen, a complement factor B antisense and the first RNA-targeted IgA nephropathy therapy, significantly reduced proteinuria versus placebo at week 37 in an interim analysis of the phase III MAgINATION study. Hansoh's TYK2 allosteric inhibitor HS-10374 met both co-primary endpoints in phase III plaque psoriasis, with significantly more patients reaching PASI 75 and sPGA 0/1 than placebo at week 16; filing is planned. Beacon's laruparetigene zovaparvovec became the first gene therapy to hit a phase III primary endpoint in X-linked retinitis pigmentosa, with 31% of higher-dose patients gaining 15 or more LLVA letters. In CARTITUDE-2, half of earlier-line RRMM patients remained progression-free at five years after one CARVYKTI infusion.

On this pageThe FDA issued a direct final rule allowing validated, appropriate non-animal methods to supplement or replace animal testing for preclinical drug and biologic safety, replacing 'animal tests' with 'nonclinical tests.' HHS, in its second such announcement this year, paired the rule with $88 million in NIH funding for 10 infrastructure projects backing cell-based assays, organs-on-chip and computer models. In dealmaking, Telix Pharmaceuticals agreed to acquire Germany's ITM Isotope Technologies Munich for about $1.65 billion on a cash-free, debt-free basis, with up to $700 million more contingent on ITM's lead drug. ITM holders receive roughly $1.25 billion in Telix shares at $11.84 each, leaving them with about 23.7% of the combined company.