Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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ALS Drugs: Second US FDA Meeting On AMX0035 Gives Amylyx A Chance To Capitalize On Recent Events
Company is coming into its second panel meeting with new data analyses from the CENTAUR trial, advisory committee experience under its belt, and a recent Health Canada approval. In an interview with the Pink Sheet, co-CEOs Cohen and Klee highlight clinical outcomes data with AMX0035 and say they are not too worried about the lack of effect on neurofilament biomarker.
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.
Kanaph CEO On Surviving The Biotech Funding 'Barley Hump'
The CEO of Korean bioventure Kanaph Therapeutics, Byoung Chul Lee, talks to Scrip about the difficulties such companies are going through amid generally weak investor sentiment, as well as the company's own financing and R&D plans.