Phase 3
The companies announced that Dupixent was the first biologic to significantly reduce itch and skin lesions in patients with Prurigo Nodularis in the Phase III trial.
AstraZeneca has been struggling to find an effective use for its anti-CTLA-4 antibody tremelimumab. It may have finally found it.
A checkpoint inhibitor under development from China’s CStone Pharmaceuticals hit the mark in a Phase III non-small cell lung cancer study.
A study conducted by 23andMe and published in Nature Genetics identified a genetic risk factor tied to the loss of smell from COVID-19.
Moderna is poised to commercialize its COVID-19 and influenza combination vaccine by the fall of 2023, with some potential for the same drug to also be viable against the RSV.
The agency recommended another clinical trial be conducted to confirm the data from the study on the 3.2-mg dose of the intranasal carbetocin for Prader-Willi syndrome.
The extensions are due to the FDA’s requiring more time to review additional clinical data it had requested from bluebird.
The decision to carry on came after dosing for the Phase III GENERATION HD1 trial was halted following an overall risk/benefit assessment.
Expanded approval for Rinvoq was based on three Phase III studies that included more than 2,500 patients. The studies met all primary and secondary endpoints.
The approval of Cibinqo was based on data from five clinical trials of more than 1,600 people. Safety and efficacy were studied in three Phase III trials.
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