The Belgian group was stunned by an FDA rejection in May for its dual IL-17A and IL-17F inhibitor and although the refiling is complete, UCB may still have to wait six months to get Bimzelx into the all-important US psoriasis market.
There is light once again at the end of the tunnel for UCB S.A.'s Bimzelx to finally enter the highly competitive US psoriasis market and the Belgian group is also making good clinical progress in other indications, reviving hopes that the IL-17A and IL-17F inhibitor will eventually reach blockbuster status.
Having comfortably secured approval for psoriasis in the EU and the UK in August last year for Bimzelx (bimekizumab), UCB...
Nemluvio is a first-in-class IL-31 inhibitor that the US FDA approved for prurigo nodularis.
New pivotal data on Regeneron and Sanofi’s antibody in chronic urticaria are underwhelming, though probably sufficient for approval. A green light may beckon in bullous pemphigoid, too.
The Danish firm’s dermatology products have made significant strides in the past six months, leading to an upwards revision of its sales forecast for full-year 2024.
TMB-001, a topical formulation of isotretinoin, missed its primary endpoint in the ASCEND study and will not be filed for approval. Leo is turning its attention to hand eczema and dealmaking.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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