Biopharmas and investors have been warning of the Inflation Reduction Act’s potential to hurt patients — concerns that had been theoretical until last week, when Alnylam became the first company to announce that it may abandon plans to add an indication to an orphan drug’s label. On the latest BioCentury This Week podcast, BioCentury’s editors discuss why a provision in the IRA prompted the biotech to pause plans to start a Phase III trial of vutrisiran for Stargardt disease, what other therapies might be affected and the impact on patients. The BioCentury podcast team also discusses how Argenx is applying lessons of past orphan drugs to the launch of myasthenia gravis drug Vyvgart, as well as non-profit Accumulus Synergy Inc.’s plans to bring interactions between drug sponsors and regulators, and among regulators, into the 21st century.

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