Drug Makers Denounce Court Ruling Overturning Abortion Drug Approval
Industry executives, trade groups and medical organizations said the ruling undermines the US FDA, flies in the face of science and would harm innovation by drug makers if allowed to stand.
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Agency appeals Texas federal court decision staying its approval of the medication abortion pill. It is unclear how the ruling would be implemented if it stands, and what the impact might be from an opposing same-day order from another court for FDA to keep mifepristone available. Texas ruling could have significant consequences for industry, former FDA attorney says.
Novartis envisions the drug, the first oral monotherapy for PNH, as a “pipeline in a pill” that could see $3bn in peak sales, with a Phase III readout in IgAN in October and one in C3G expected this month.
Experts see allogeneic CAR-Ts as less likely to carry potential risks of T-cell malignancies, and an opportunity for differentiation against the crowded autologous CD19-directed CAR-T space.