Rx Spending Growth To Be Driven By New Drug Entries, CMS Says
Advances in cancer, diabetes, and Alzheimer's could lead to expensive new treatments, contributing to spending increases in next decade, according to CMS projections.
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Draft guidance says US FDA will not assume a product has launched, the final requirement to receive the promised 180-day exclusivity, unless notified by the sponsor.
The recent failure of the CREAD studies to show a therapeutic effect for crenezumab in Alzheimer’s disease stunned developers. However, an ongoing clinical study of the MAb, and a series of other innovations being explored at Switzerland’s AC Immune, might still provide answers to this intractable condition.
Years of regulatory fine-tuning culminated in record low average time to approval of 9.9 months for novel agents at US FDA’s drug center.