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- Biogen pushing tau drug forward despite Alzheimer’s study failureOne of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial.BioPharma Dive · 2mo ago↗ source
- With new data, Regenxbio to seek FDA approval of Duchenne gene therapyThough two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA leadership will have a “mandate on rare disease flexibility.”BioPharma Dive · 2mo ago↗ source
- FDA’s leadership void leaves biotech with renewed ‘uncertainty’Marty Makary's resignation leaves the agency with temporary directors in three top positions, and a number of newly instituted policies with an unclear future.