Shortly after Amgen Inc. walked away from its partnership with Kyowa Kirin Co. Ltd., the Tokyo-based company said it is discontinuing all ongoing clinical trials for rocatinlimab due to safety concerns.

The OX40-targeting mechanism pursued by drug developers around the world found itself shadowed March 3 when Kyowa Kirin Co. Ltd. gave up work with rocatinlimab, a monoclonal antibody for which hopes had risen in moderate to severe atopic dermatitis, prurigo nodularis and moderate to severe asthma.

Shortly after Amgen Inc. walked away from its partnership with Kyowa Kirin Co. Ltd., the Tokyo-based company said it is discontinuing all ongoing clinical trials for rocatinlimab due to safety concerns.

The U.S. FDA approved 18 drugs in November, down from 20 in October, bringing the total number of clearances to 199 through the first 11 months of the year. The number is about 5% lower than the 209 approvals recorded over the same period in 2024 but more than every prior year.

The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.

The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.

Boehringer Ingelheim GmbH has licensed an unnamed small-molecule preclinical candidate from Kyowa Kirin Co. Ltd. in the autoimmune disease space in a deal worth up to €640 million (US$739 million).

Boehringer Ingelheim GmbH has licensed an unnamed small-molecule preclinical candidate from Kyowa Kirin Co. Ltd. in the autoimmune disease space in a deal worth up to €640 million (US$739 million).