Lilly Strikes Out With The FDA For Second Time This Year With Mirikizumab CRL
Agency Denied Donanemab Accelerated Approval In January
With mirikizumab delayed until Lilly overcomes the FDA’s manufacturing concerns, the company has fallen behind on its goal of five approvals in 2023.
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AstraZeneca’s IBD Hopes Deflated Amid Evolving Market And Pipeline Competition
The major’s attempt to break into Crohn’s disease and ulcerative colitis has been cut short as a highly competitive market and pipeline, intensified by the entrance of biosimilars, renders further development of brazikumab impractical.
Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters
Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.
First Phase III IBD Trial Reads Out Positive For Janssen’s Tremfya
The IL-23 inhibitor, entering an increasingly competitive space, posted significant results at Digestive Disease Week from the Phase IIb/III QUASAR induction study in ulcerative colitis.