On January 8, 2026, AskBio Inc., a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AB-1009. This investigational adeno-associated virus (AAV) gene therapy is designed for the treatment of late-onset Pompe disease (LOPD), a rare, progressive genetic metabolic disorder caused by deficiency of the enzyme acid alpha-glucosidase (GAA). Reduced or absent GAA levels lead to glycogen accumulation in muscles and tissues, resulting in progressive skeletal muscle weakness, respiratory insufficiency, and significant morbidity; without early intervention, the disease can lead to premature death.
The TOGETHER-PsA trial (NCT06588296) is a 52-week, randomized, multicenter, assessor-blinded, open-label Phase 3b study evaluating the efficacy and safety of concomitant subcutaneous ixekizumab (Taltz, an IL-17A inhibitor) and tirzepatide (Zepbound, a dual GIP/GLP-1 receptor agonist) compared to ixekizumab monotherapy in 271 adults with active psoriatic arthritis (PsA) and obesity (BMI ≥30 kg/m²) or overweight (BMI 27-29.9 kg/m² with ≥1 weight-related comorbidity). Participants had high baseline disease burden (mean DAPSA score 58.65, HAQ-DI 1.3) and mean BMI 37.6 kg/m²; over 60% had prior advanced therapy exposure. Both arms included lifestyle counseling for reduced-calorie diet and physical activity.
In a randomized crossover clinical trial (NCT05263232), Harmsen et al. investigated the metabolic effects of natural daylight exposure during office hours in individuals with type 2 diabetes (T2D). Thirteen participants with T2D, virologically suppressed on treatment, were exposed to either natural daylight (facilitated through windows) or constant artificial office lighting for 4.5 consecutive days in a controlled setting, with interventions separated by a washout period.
GSK announced on January 7, 2026, positive topline results from the two pivotal Phase III trials, B-Well 1 (NCT05630807) and B-Well 2 (NCT05630820), evaluating bepirovirsen, an investigational triple-action antisense oligonucleotide (ASO), as a potential first-in-class finite treatment for chronic hepatitis B (CHB).
GSK announced that the European Commission (EC) has approved a new prefilled syringe presentation for Shingrix (Recombinant Zoster Vaccine, Adjuvanted; RZV), a key advancement designed to streamline vaccine administration. Previously, Shingrix required reconstitution by mixing a lyophilised powder antigen vial with a liquid adjuvant suspension. The new ready-to-use prefilled syringe eliminates this step, offering healthcare professionals a more convenient option without altering the vaccine’s composition, efficacy, safety profile, indication, or two-dose regimen.
