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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.

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Opportunities Amid Crisis: Junshi, Allist Look To Expand Pipelines Through Alliances, M&A

Against the prevailing headwinds in the biotech sector, two Chinese firms are bucking the trend of pipeline reorganization by eyeing the potential acquisition of assets from external partners to expand into more modalities and therapeutic areas.

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FibroGen’s Roxadustat On The Rocks After Phase III Myelodysplastic Syndrome Failure

MATTERHORN’s failure did not surprise analysts, but it’s likely the end of the road for roxadustat in the US market. The focus instead has shifted to FibroGen’s IPF asset pamrevlumab.

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