Lilly’s Donanemab Slows Cognitive Decline; FDA Filing Imminent
Full Approval Sought After Accelerated Nod Denied Previously
The company’s anti-amyloid antibody succeeded in Phase III with efficacy at least on par with Eisai/Biogen’s Leqembi, but with ARIA-related deaths unseen with the rival therapy.
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New Therapeutic Areas Ignite Investor Interest Amid Pandemic Reset
Investor attention is turning increasingly to new products and new areas of growth like obesity, Alzheimer’s disease and RSV as big blockbusters face increasing competitive pressure.
Eisai/Biogen’s Leqembi Gets Some Medicare Coverage Certainty In CMS Update
CMS said Medicare will cover anti-amyloid antibodies for early Alzheimer’s disease upon traditional approval from the US FDA if prescribed by doctors participating in a patient registry.
Big Pharma R&D Chiefs On IRA’s Unintended Casualty, Product Life Cycle Compression
R&D heads of Takeda, Amgen, Lilly and Novartis discuss some of the tectonic forces shaping the biopharma sector and the unintended consequences of the IRA on small molecule innovation. Advances in the neurodegenerative diseases segment amid impressive data from donanemab was another key talking point.