Food and Drug Administration (FDA)
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Eisai and Biogen’s BLA for lecanemab for Alzheimer’s disease received FDA Priority Review with a target action date of January 6, 2023, while Roche’s lymphoma drug scored the same designation.
As the calendar pages continue to turn, the FDA has a slew of novel drugs awaiting approval, several of which are likely to become game-changers for patients and key assets for companies.
The FDA lifted the clinical hold on Dyne Therapeutics’ clinical study of DYNE-251 in Duchenne muscular dystrophy (DMD) patients amenable to skipping exon 51. A Phase I/II trial is expected by mid-year.
Following the Supreme Court’s decision to overturn Roe v. Wade, abortion rights activists are calling for the FDA to consider making abortion medication Mifeprex an over-the-counter option for patients.
Seagen announced positive data from its Phase II trial in colorectal cancer, and the FDA provided positive feedback supporting a Phase IIIb trial for ANeuroTech’s MDD drug.
The FDA lifted its clinical hold on Vertex Pharmaceuticals’ Phase I/II clinical trial of VX-880, a pancreatic islet cell replacement therapy for people with Type I Diabetes (TID).
Hyloris did not provide details on the FDA’s concern regarding Maxigesic IV but said it will fully comply with whatever is necessary to move the product forward.
Provention Bio announced the FDA extended its review period by three months for the Biologics License Application (BLA) of its diabetes prevention drug, teplizumab to Nov. 17.
Citing an unnamed FDA insider, the regulator is in the process of devising a plan to enable clinical testing on a larger scale.
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