The week in pharma: action, reaction and insight - week to October 15, 2021
By Barbara Obstoj-Cardwell
Significant regulatory news last week included Swiss pharma giant Roche gaining Breakthrough Therapy designation from the US Food and Drug Administration for its Alzheimer’s candidate gantenerumab. Also, Eli Lily last Wednesday was granted FDA approval for its CDK 4/6 inhibitor Verzenio in an early breast cancer indication. Swiss biotech Idorsia suffered a setback last Monday when the firm reported that its Fabry disease hopeful lucerastat missed endpoints in a Phase III trial. An FDA advisory panel last Thursday voted in favor of approving Moderna’s COVID-19 vaccine – Spikevax - to be used for booster jabs. And on Friday the AdCom also backed booster jabs of Johnson & Johnson’s vaccine.
FDA adds a failed Alzheimer's drug to the 'breakthrough' club now looking for a near-term OK
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