FDA Rejects ITM Radiopharmaceutical Over Manufacturing
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- FDA rejected a radiopharmaceutical therapy because of manufacturing issues, halting what would have been a competitor to Novartis, STAT reports.
- ITM Isotope Technologies Munich SE developed the drug and last month launched a new division, Lumara Bio, to commercialize and sell it.
- Radiopharmaceuticals are an emerging treatment class designed to deliver radioactive isotopes directly at tumor cells.
- Hims & Hers plans to enter the peptides market before year-end, selling already-allowed compounds that patients seek for wellness and longevity despite limited clinical evidence, Bloomberg News reports.
- The FDA is deciding whether to loosen restrictions on seven peptide compounds, following a hearing last month in which outside advisers recommended easing production limits and expanding access.
Why it matters: The FDA's rejection eliminates a Novartis competitor in a fast-growing cancer treatment category, and the timing stings: ITM had just launched a dedicated commercial arm (Lumara Bio) for this same drug. Separately, Hims & Hers is moving ahead of a pending FDA decision on whether to loosen restrictions on seven peptide compounds.
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