FDA grants priority review for AZ, Amgen’s tezepelumab for asthma

The US Food and Drug Administration (FDA) has accepted AstraZeneca (AZ) and Amgen’s submission for their investigational asthma drug tezepelumab and granted a priority review for the therapy. . ... AZ and Amgen’s drug acts further upstream in the

US Supreme Court rebuffs Sandoz’s Enbrel biosimilar patent case

Erelzi references Amgen’s blockbuster arthritis drug Enbrel (etanercept) – Sandoz had been hoping to launch the biosimilar as a ‘more affordable’ treatment option for US patients. ... This decision also ruled against Sandoz, with the Federal

AZ, Amgen file first-in-class asthma drug with the FDA

AstraZeneca (AZ) and Amgen have submitted a biologic license application (BLA) for their first-in-class asthma drug tezepelumab to the US Food and Drug Administration (FDA). ... AZ and Amgen are seeking approval for tezepelumab for the treatment of

Alexion and NICE agree confidential discount for Ultomiris use on the NHS

In 2020, Alexion reached a patent settlement with Amgen, preventing a biosimilar version of the drug from entering the US marketing until 2025.

1 2 3 4 5 6 7 8 9 10 [ Next 5 results ]