With the drug demonstrating superiority over approved psoriasis therapies such as Cosentyx, Stelara and Humira in clinical trials, UCB's bimekizumab will shortly compete against these well-entrenched rivals on the European market, following a thumbs-up from the CHMP.
Having generated a hefty package of positive data, including wins in head-to-head trials with psoriasis market leaders such as Novartis AG's Cosentyx and Johnson & Johnson’s Stelara, UCB S.A.'s bimekizumab is finally set to cross the finishing line after being recommended for approval by EU regulators for psoriasis.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization...
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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