Amgen and AstraZeneca announced that the U.S. FDA has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype. A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results which…
Prefilled Drug Cartridge Launched To Treat Arthritis, Other Chronic Conditions
Amgen launches the Enbrel Mini single-dose prefilled cartridge with AutoTouch reusable autoinjector that is ergonomically designed for patients. Amgen announced that the Enbrel Mini with AutoTouch is now available in the United States. Awarded the Arthritis Foundation Ease of Use Commendation, the new delivery system provides an additional administration option for appropriate Enbrel patients. The AutoTouch reusable autoinjector has an…
Amgen and UCB Receive Complete Response Letter for Osteoporosis Drug
Amgen Seeks to Include Overall Survival Data for Myeloma Treatment
Amgen’s Amgevita Biosimilar Okayed in Europe for Inflammatory Diseases
EU Approves New Single-Dose Delivery Option for Repatha
Repatha (evolocumab) receives European Commission approval for new 420 mg single-dose delivery option. Amgen announced that the European Commission (EC) has adopted a decision to change the Repatha (evolocumab) marketing authorization, approving a new single-dose delivery option. The new automated mini-doser (AMD) with a pre-filled cartridge is a hands-free device that provides 420 mg of Repatha…