Category: News

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.

Regulatory Approval Autoimmune Diseases News

FDA Approves First-of-its-Kind Psoriasis and Arthritis Treatment for Children

JohnsonAndJohnson

The U.S. Food and Drug Administration (FDA) has given approval to TREMFYA® (guselkumab) for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in children. This groundbreaking approval makes TREMFYA® the first and only IL-23 inhibitor available for pediatric patients, offering a new ray of hope for thousands of children affected by these chronic conditions.

Regulatory Neuroscience News

European Commission Grants Marketing Authorization for Lilly’s Kisunla (donanemab) for the Treatment of Early Alzheimer’s Disease

Eli Lilly and Company

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.

Oncology News Regulatory Approval

FDA Approves Lilly’s Inluriyo (imlunestrant) for Advanced ER+, HER2- Breast Cancer with ESR1 Mutation

Eli Lilly and Company

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.

Clinical Trials Autoimmune Diseases Healthcare & Pharmaceuticals News

Roche Highlights New OCREVUS® Data Demonstrating Benefit in Diverse MS Populations and Presents Promising Long-Term Fenebrutinib Results at ECTRIMS 2025

Roche

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.

Clinical Trials Healthcare & Pharmaceuticals News Oncology

Roche’s Giredestrant Combination Shows Significant Benefit in Advanced ER-Positive Breast Cancer

Roche

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.

Business Healthcare & Pharmaceuticals News

Pfizer Acquires Metsera in $4.9 Billion Deal, Bolsters Obesity Drug Portfolio

pfizer news

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.

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.