The company reported Onivyde and 5 fluorouracil/leucovorin and oxaliplatin demonstrated a statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine regimen. The study also met its key secondary endpoint of progression-free survival.

GSK is planning a Phase III trial evaluating bepirovirsen as a potential functional cure for chronic hepatitis B infection, despite the most recently released data appearing less robust than the interim analyses. The trial is expected to begin in the first half of 2023.

Two Phase III trials of Genentech (Roche)’s Vabysmo hit the primary endpoint in macular edema caused by branch and central retinal vein occlusion (BRVO), showing non-inferiority to Regeneron’s Eylea. 

New Phase III data shows Novartis’ experimental iptacopan demonstrated superiority against AstraZeneca subsidiary Alexion’s Soliris and Ultomiris in paroxysmal nocturnal hemoglobinuria (PNH).

Sage Therapeutics and Biogen’s zuranolone met its primary and key secondary endpoints in the Phase III SKYLARK study of women with postpartum depression (PPD), the companies announced Monday.

Studies in Japan were inconclusive, leading domestic regulators to hold off on approval, partly because data from animal studies showed it could lead to birth defects. The pill was once hailed as Japan’s biggest contribution to the global coronavirus fight.

Data from an ongoing Phase III trial showed Sanofi/Regeneron’s Dupixent (dupilumab) can induce histological disease remission in young eosinophilic esophagitis (EoE) patients ages 1–11 years, the companies announced Tuesday.

Life-threatening safety concerns prompted KalVista Pharmaceuticals to shut down a mid-stage clinical trial for hereditary angioedema, the swelling of skin in response to an allergic reaction, the company announced Tuesday. 

Pfizer is leveraging its funding and experience with vaccines for meningococcal, flu and RSV to further expand its presence in the field.

Non-small cell lung cancer (NSCLC) was a hot topic at the recent European Society for Medical Oncology (ESMO) Congress, where several researchers presented landmark findings, many of which are considered to be firsts. Such results portend advances that could significantly improve survival for patients with this common form of cancer.