Busy week for BCMA. On Monday, the FDA granted Gilead/Kite a CATMA-recognized CAR-T therapy orphan drug. At the same time, at the myeloma 2018 meeting, Amgen also announced early clinical data on its TBMA-targeted BiTE drug AMG-420. Affected by the data, the shares of Bluebird Bio and Celgene fell on… Continue Reading CAR-T confronts double antibodies, and Amgen’s drugs targeting BCMA may be a huge threat to Bluebird

Just as several large pharmaceutical companies faced patent cliffs several years ago, the next six years, another wave of original research drugs face patent limits. A recent EvaluatePharma report stated that between 2018 and 2024, sales of medicines that are about to lose patent protection amounted to US$250 billion. The… Continue Reading A new wave of patent cliffs arrives, affecting 250 billion US dollars of original research varieties

Amgen announced on June 11 that the FDA had approved its supplementary application and was approved to write positive survival data in the ASPIRE Phase III study into the drug label of Kyprolis, namely: Kyprolis plus lenalidomide plus dexamethasone. Treatment of patients with relapsed and refractory multiple myeloma who had… Continue Reading FDA Approves Kyprolis to Update Drug Labels: Death Risk Decreases by 21%, OS Extends 7.9 Months

On June 4, the FDA approved the marketing of Mylan Fulphila (pegfilgrastim-jmdb) to reduce the risk of neutropenia infection and fever. Fulphila is the 10th biosimilar approved by the FDA and the first biosimilar of Amgen Neulasta (pegfilgrastim).   Amgen launched the world’s first recombinant human granulocyte colony-stimulating factor, Neupogen… Continue Reading The first bioanalogue of Amgen’s $4.5 billion product