Drug Development
Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
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Recent breakthroughs and three decades of progress in treating Huntington’s disease
Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, global consistency and broader patient access to CAR T therapies.
As 2026 begins, a slate of high-stakes clinical readouts—from a pivotal study of Novartis’ cardiovascular candidate pelacarsen to a Phase III test of Eli Lilly’s next-gen Alzheimer’s drug—are poised to reshape therapeutic landscapes.
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While the trial was designed to test safety and not efficacy, patients treated with Araclon Biotech’s experimental ABvac40 vaccine saw a 38% drop in disease progression compared to placebo.
The company’s respiratory syncytial virus vaccine Arexvy can elicit similar levels of immune protection in adults aged 50 to 59 as in its approved population, finds results from a late-stage study.
The regulator lifted a clinical hold on Verve Therapeutics’ CRISPR-based therapy clearing its Investigational New Drug application and plans to evaluate VERVE-101 in a Phase I heterozygous familial hypercholesterolemia trial.
The regulator has approved the first-ever subcutaneous version of infliximab, an IgG1 monoclonal antibody, commonly sold by Johnson & Johnson under the brand name Remicade.
The companies presented data from two pivotal studies of Dato-DXd, focusing on safety concerns and survival data for the investigational antibody-drug conjugate candidate in lung and breast cancer.
Pluvicto improved radiographic progression-free survival in PSMA-positive patients with metastatic castration-resistant prostate cancer who had not been treated with taxane-based chemotherapy.
A Discussion with IQVIA’s Michelle Gyzen Sr. Director, Regulatory Affairs and Drug Development Solutions
A first-in-class clinical trial will initiate this quarter to determine if a checkpoint agonist can down-regulate activated T cells to help reduce inflammation and tissue damage in patients with moderate-to-severe ulcerative colitis (UC).
Uniting thought leaders across the life sciences landscape, JLABS @ NYC rejoices in five years of catalyzing startups.
The competitors posted promising survival data for their respective blockbuster PD-1 inhibitors—Keytruda and Opdivo—emphasizing the potential of these therapies in bladder cancer patients.