AbbVie reaches a key milestone by submitting a Biologics License Application (BLA) to the FDA for Pivekimab sunirine (PVEK), an investigational Antibody-Drug Conjugate (ADC) designed to treat the rare and aggressive blood cancer, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN).
Eli Lilly and Company announced the European Commission has granted marketing authorization for Kisunla (donanemab) to treat early symptomatic Alzheimer’s disease. The therapy demonstrated a significant slowing of cognitive and functional decline and is unique for supporting a finite treatment course.
The U.S. Food and Drug Administration (FDA) has officially approved Eli Lilly and Company’s Inluriyo (imlunestrant), a new oral therapy for adult patients with advanced or metastatic estrogen receptor-positive (ER+), HER2-negative breast cancer that has an ESR1 mutation. The approval is based on the pivotal Phase 3 EMBER-3 trial, which demonstrated that Inluriyo significantly reduced the risk of disease progression or death by 38% in this patient population, offering a new and convenient treatment option for a challenging form of breast cancer.
Roche is set to present a wealth of new data at the 41st ECTRIMS Congress, highlighting the expanding benefits of its flagship multiple sclerosis therapy, OCREVUS® (ocrelizumab). New findings demonstrate a significant reduction in disability progression for adults with advanced primary progressive MS (PPMS) and reinforce its safety for pregnant women and their infants. The presentation will also include the first comparative data for OCREVUS in pediatric MS. Alongside these updates, Roche will showcase promising two-year results for its investigational oral BTK inhibitor, fenebrutinib, which showed near-complete suppression of disease activity in patients with relapsing MS ahead of pivotal Phase III readouts.
Roche’s Phase III evERA study for the investigational drug giredestrant has delivered positive results, showing a significant improvement in progression-free survival for patients with advanced ER-positive breast cancer. The all-oral combination therapy, which was well-tolerated, offers a new, promising treatment option for individuals whose disease has progressed after previous treatments.
Pfizer has announced a definitive agreement to acquire clinical-stage biopharmaceutical company Metsera in a deal valued at an initial $4.9 billion, with the potential for an additional $2.4 billion in milestone payments. The acquisition is a strategic move to re-enter the lucrative weight-loss drug market by adding Metsera’s next-generation obesity and cardiometabolic disease treatments, including promising oral and injectable therapies, to Pfizer’s pipeline.
The U.S. Food and Drug Administration (FDA) has approved Merck’s Keytruda Qlex, a new subcutaneous formulation of its leading cancer immunotherapy drug. This game-changing approval introduces a fixed-dose combination of pembrolizumab and berahyaluronidase alfa-pmph, allowing the treatment to be administered as a simple injection in as little as one minute, a significant reduction from the previous 30-minute intravenous infusion. Approved for most of Keytruda’s existing solid tumor indications in adults, this new formulation was shown in clinical trials to have a comparable efficacy and safety profile to the IV version. The approval marks a major advancement in patient-centered care, offering a more convenient and less time-consuming option for thousands of cancer patients.
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a new subcutaneous (at-home) induction option for TREMFYA® (guselkumab) for adults with moderately to severely active ulcerative colitis. This approval, based on the successful Phase 3 ASTRO trial, makes TREMFYA the first and only IL-23 inhibitor to offer a completely subcutaneous regimen for both induction and maintenance, providing a significant new convenience for patients managing their condition.
Eli Lilly and Company announced positive topline results from its SURPASS-PEDS Phase 3 trial for Mounjaro (tirzepatide). The study, which evaluated the GIP/GLP-1 dual receptor agonist in children and adolescents with type 2 diabetes, demonstrated substantial and statistically significant improvements in blood sugar control and weight management, with a safety profile consistent with adult studies.
New data published in The New England Journal of Medicine shows the once-daily pill led to significant weight loss and improved cardiometabolic health in adults with obesity or who are overweight.
