Drug pipeline 4Q22 — sticking around - Nature Biotechnology

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Drug pipeline 4Q22 — sticking around - Nature Biotechnology
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Preventative antibodies took a front seat in our 4Q22 drug pipeline Data Page, with US_FDA approving AstraZeneca and Sanofi’s Beyfortus for RSV infections and ProventionBio’s Tzield, which slows progression to full-blown T1D

One of the most significant pieces of regulatory news fell just beyond the end of 2022 as the US Food and Drug Administration gave an accelerated approval to Eisai-Biogen’s lecanemab on the basis of amyloid plaque clearance. A second anti-plaque antibody, Lilly’s donanemab, may receive an accelerated approval in early February.

The FDA also granted accelerated approval in non-small-cell lung cancer for Mirati Therapeutics’ Krazati , an irreversible covalent binder of the KRAS oncoprotein. The fortunes of small-molecule splice modulators in Huntington’s disease reversed, however, with an FDA clinical hold for PTC Therapeutics’ PTC518 and a Data Monitoring Committee recommendation to pause the phase 2b trial of Novartis’s branaplam following potential peripheral neuropathies in some patients.

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