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The 61-patient study met the primary endpoint of improved physiologic liver function and secondary endpoints, which included established non-alcoholic steatohepatitis biomarkers, Hepion reported Monday.
Sanofi and Regeneron reported positive results for the anti-inflammatory drug in a chronic obstructive pulmonary disease trial. The companies hope to see approval before a 2024 read-out of a second trial.
The topical treatment Vyjuvek got the FDA’s greenlight, making it the first redosable gene therapy and the first therapeutic for the rare skin disease dystrophic epidermolysis bullosa.
With Friday’s approval, Epkinly edges out Roche’s bi-specific antibody glofitamab, which is also being proposed for diffuse large B-cell lymphoma.
Crohn’s disease is Rinvoq’s seventh approved indication and could potentially help AbbVie weather declining sales for its blockbuster biologic Humira.
Blueprint Medicines, Indivior PLC and Lexicon Pharmaceuticals are all awaiting FDA decisions this week.
The regulator’s approval makes Miebo the first DED treatment that directly addresses tear evaporation. The drug is expected to hit U.S. markets in the second half of 2023.
According to the FDA, the majority of therapies prescribed for children were not tested in pediatric populations. The new guidance aims to change that.
The extensive discussion between the FDA’s advisory committee, company representatives and other interested parties could serve as a cautionary tale to developers of future gene therapies.
The U.S. Supreme Court unanimously ruled Amgen’s cholesterol drug Repatha patents invalid, ending a protracted legal battle with competitors Sanofi and Regeneron.
Under a non-exclusive agreement, AstraZeneca is licensing biotech Revvity’s base editing technology to help create cell therapies for the treatment of cancer and immune-mediated diseases.
A three-judge panel is reviewing the legal challenge to the FDA’s approval of mifepristone. Any action by the court may result in further appeals, and possibly another Supreme Court decision.