Phase III
Subcutaneous injections of Eisai and Biogen’s Leqembi led to numerically greater amyloid removal than the intravenous version of the Alzheimer’s disease therapy, though risks of brain swelling and bleeding remained.
Following the regulator’s denial of patisiran’s label expansion, Alnylam has published late-stage data for the RNAi therapeutic in The New England Journal of Medicine demonstrating its efficacy in ATTR-cardiomyopathy.
With the potential FDA approval of an MDMA-based therapy for PTSD on the horizon, biopharma stakeholders are eyeing psychedelics with fresh anticipation.
High multiplexed patient-centric assays could reduce patient burden
Protocol design optimization and timely engagement of regulators are the crux of optimized, patient-centric clinical trials.
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 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.
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.
The two-part formulation of subcutaneous nivolumab combined with Halozyme’s proprietary recombinant human hyaluronidase achieved two primary endpoints while also showing a noninferior overall response rate.
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