With this approval — which saw the drug given Priority Review, Breakthrough Therapy Designation and Orphan Drug Designation by the FDA — Rituxan becomes the first biologic therapy for the disease.
The Afinion 2 streamlines and simplifies the delivery of accurate measurements of hemoglobin A1c, or HbA1c, and albumin to creatinine ratio results at the point of care, the company said.
The companies are rolling out MedAvail’s MedCenter self-service pharmacy kiosks in Phoenix and Tucson, offering securely dispensed chronic and acute prescriptions, as well as OTC medications 24/7.
The Memphis-based company unloaded the business unit, EntrustRx, to a CVS Health subsidiary for a $40 million aggregate consideration, plus the value of its inventory.
The Food and Drug Administration sent Amgen a complete response letter for its Biologics License application for potential Herceptin biosimilar ABP 90.
Fulphila is the first U.S. biosimilar of the drug from Amgen and is indicated to reduce the duration of febrile neutropenia in patients treated with chemotherapy in certain types of cancer.