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Keeping Track: Spectrum Submits Poziotinib; US FDA Approves Daré’s Xaciato, Expands Heron Zynrelef Label

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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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Spectrum’s Delay In Starting Confirmatory Trial Of Poziotinib Troubles US FDA

Ahead of advisory committee review, agency cites poziotinib’s marginal anti-tumor activity, high rates of toxicity, and lack of dose optimization. Company seeks accelerated approval but was given standard review.

US FDA Panel To Weigh Safety, Tolerability Issues For One New, Two Approved Cancer Drugs

Oncologic Drugs Advisory Committee will review Spectrum’s poziotinib for use in targeted subset of patients with previously treated non-small cell lung cancer; ODAC also will consider next steps for two approved drugs with adverse survival trends in postmarketing studies: Oncopeptides’ Pepaxto in multiple myeloma and Secura Bio’s Copiktra for CLL/SLL.

Deal Watch: Jazz Breaks Into Immuno-Oncology Via Licensing Pact With Werewolf

AstraZeneca licenses bispecific cancer antibody candidate from Harbour Biomed. Regeneron seeks new approach to gene therapy delivery in deal with ViGeneron.

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