STAT+: Pharmalittle: We’re reading about an FDA rejection, 340B court battles, and more
The FDA rejected a radiopharmaceutical therapy because of manufacturing issues, halting what would have been a competitor for Novartis
On a bright and pleasant day, Pharmalot reported on several noteworthy developments in the pharmaceutical industry. The U.S. Food and Drug Administration (FDA) declined to approve a radiopharmaceutical therapy due to manufacturing concerns, preventing ITM Isotope Technologies Munich SE from entering the competitive market dominated by Novartis.
ITM Isotope Technologies Munich SE, a well-established player in the radiopharmaceutical field, had recently established Lumara Bio to handle the drug's commercialization and distribution. Meanwhile, Hims & Hers, a telehealth company, announced plans to enter the peptides market before the end of the year, capitalizing on the increasing demand for wellness and longevity products, despite limited clinical evidence supporting their efficacy.
The FDA recently held a hearing, where experts suggested easing restrictions on seven different compounds, potentially paving the way for broader access to these products. For further details, readers were directed to the full story on STAT+.
Written by urgent.news from STAT News's reporting — not their text. Machine-written — it may contain errors, so check the original before relying on it.
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