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Latest From Zogenix, Inc.
UCB Wins Two Key US Approvals: Bimzelx In Psoriasis, Zilbrysq In gMG
Two years after its first FDA review, UCB’s next blockbuster Bimzelx finally crossed the finish line. Supplemental filings for more indications will soon follow as the company forecasts €4bn in peak sales.
UCB Bullish On Bimzelx Despite Sluggish Start
While sales for the dual interleukin-17A and IL-17F inhibitor only reached €35m last year, UCB immunology chief Emmanuel Caeymaex is confident that figure will leap over the €200m barrier in 2023, if US approval for Bimzelx for psoriasis comes in the next quarter.
US FDA Advisory Committee ‘Update’ May Result In More Meetings – And More Re-Reviews
Commissioner Robert Califf’s comments offer further context for FDA’s unprecedented decision to reconvene an advisory committee for a second review of Amylyx’ AMX0035 for ALS.
What Might FDA Do Post Roe? Eliminate Mifepristone REMS
Attorneys say the biggest step FDA could take to expand access to medication abortion would be to eliminate REMS requirement for mifepristone. Timeline notes steps Biden administration and Congress have taken since the Supreme Court’s ruling overturning the right to an abortion.
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- Brabant Pharma, Modis Therapeutics, Inc. Zogenix International, Ltd. Zogenix Europe Limited
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