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Biogen and Eisai’s Alzheimer’s drug secures support in closely watched AdCom

Pharmaceutical Technology

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

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SNIPR targets antibiotic resistance with CRISPR-based gene therapy trial

Pharmaceutical Technology

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. Subjects were dosed over seven days, and reportedly only experienced mild to moderate side effects with no withdrawals. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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FDA proposes new model for easy-to-understand prescription guides

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The FDA said that the proposed revamp should help limit preventable adverse drug reactions and improve health outcomes.