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- ITM neuroendocrine tumor drug spurned by FDA over manufacturing qualmsThe FDA has denied ITM Isotopes Technologies’ lead pipeline candidate for a rare group of tumors due to qualms over the drug’s manufacturing.Fierce Biotech · 6h ago↗ source
- Scholar Rock ditches Novo’s legacy Catalent plant in FDA refiling of SMA drugScholar Rock has dropped Novo Nordisk’s troubled Catalent facility as a contract manufacturer in its FDA refiling for apitegromab, a spinal muscular atrophy candidate, after a recent inspection of…Fierce Biotech · 7h ago↗ source
- Arpeggio plays final chord as biotech disbands on poor prospects for Nrf2 programArpeggio Biosciences’ eight-year song has come to an end, as the transcriptome biotech’s CEO admitted the that company’s Nrf2 program had begun to “unravel.”