Amgen and Provention Bio Enter Development Collaboration in Celiac Disease
Amgen and Provention Bio, Inc., a clinical-stage biopharmaceutical company focused on immune-mediated diseases, have entered a licensing and co-development agreement for AMG 714, identified by Provention as PRV-015. AMG 714 is a novel anti-IL-15 monoclonal antibody being developed for the treatment of gluten-free diet non-responsive celiac disease (NRCD). Development efforts at Provention will be led by researchers…
FDA Approves Addition Of Positive Overall Survival Data From Phase 3 ASPIRE Trial To KYPROLIS® Label
European Commission Approves Third Indication For Prolia
The European Commission (EC) has approved a new indication for Amgen’s Prolia (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. The EC approval is based on the positive results of a Phase 3 study that evaluated the safety and efficacy of Prolia compared with risedronate in…
FDA Approves Prolia For Glucocorticoid-Induced Osteoporosis
EC Approves Expanded Indication For Amgen’s XGEVA (denosumab)
Positive CHMP Opinion Indicates Repatha (evolocumab) Prevents Heart Attacks And Strokes
Amgen And Allergan Receive Positive Opinion For Biosimilar
Amgen and Allergan plc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of ABP 980, a biosimilar to Herceptin (trastuzumab). ABP 980 has been recommended for approval for the treatment of the same three types of cancer as…
New Analyses Show Payer Utilization Management Criteria Deny Access to PCSK9 Inhibitors
Amgen Receives Positive CHMP Opinion For Delivery System Of Neulasta
Amgen Receives CHMP Positive Opinion to Add Updated Overall Survival Data To KYPROLIS Label
Amgen’s Aimovig (Erenumab) Met All Endpoints in Phase 3b Study
For First Time Ever, EC Approves Biosimilar Bevacizumab from Amgen, Allergan
FDA Approves Addition Of Overall Survival Data To KYPROLIS (carfilzomib) Label
European Medicines Agency Accepts Filing For Amgen’s EVENITY
Amgen Announces New Phase III Trial Results for Kyprolis at ASH 2017
Amgen, Allergan Receive Positive CHMP Opinion for Bevacizumab Biosimilar
Amgen, Simcere Announce Strategic Collaboration to Develop Biosimilars in China
Tezepelumab Significantly Reduced Asthma Exacerbations for Broad Patient Population with Severe Uncontrolled Asthma
How Low Can LDL Go?
Amgen Reports Results for Repatha in Phase III Cognitive Function Study
FDA Grants Priority Review for Amgen’s sBLA for Repatha to Include Data on Reduced Risk for Cardiovascular Events
Amgen, Array BioPharma Announce Preclinical License and Collaboration Agreement in Inflammation
EHA 2017: Amgen to Present New Data on Hematology Portfolio
Amgen Seeks to Expand Xgeva for Multiple Myeloma Patients
Amgen submits applications in the U.S. and Europe to expand current indication for Xgeva (denosumab) to include patients with multiple myeloma. Amgen today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and an application for a variation to the marketing authorization to the European Medicines Agency…