Category: Biologics

Clinical Trials Biologics News Oncology

Amgen’s Repatha® (evolocumab) Succeeds in Landmark Phase 3 Trial, Showing Significant Reduction in Cardiovascular Events

amgen

Amgen announced that its landmark Phase 3 VESALIUS-CV clinical trial for Repatha® (evolocumab) met its primary endpoints, demonstrating a significant reduction in the risk of major adverse cardiovascular events (MACE) in high-risk individuals without a prior history of heart attack or stroke. The study, which enrolled over 12,000 patients, positions Repatha as the first and only PCSK9 inhibitor to show such a benefit in this primary prevention setting, offering a new hope for patients at high risk for cardiovascular disease.

News Biologics Oncology Regulatory Approval

U.S. FDA Approves Merck’s Keytruda Qlex, a Faster-Administered Subcutaneous Version of Keytruda for Cancer Treatment

Merck MSD

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.

Biologics Autoimmune Diseases Healthcare & Pharmaceuticals News Regulatory Approval

U.S. FDA Approves Johnson & Johnson’s TREMFYA® (guselkumab) Subcutaneous Induction for Adults with Ulcerative Colitis

JohnsonAndJohnson

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.