For the second time, Novartis AG unit Sandoz Inc. is trying to "reap the commercial benefits" provided to biosimilar manufacturers under the Biologics Price Competition and Innovation Act (BPCIA), while seeking to avoid the obligations Congress established under the 2010 law "to protect innovators," Amgen Inc. and Roche AG charged in new court documents.
For the second time, Novartis AG unit Sandoz Inc. is trying to "reap the commercial benefits" provided to biosimilar manufacturers under the Biologics Price Competition and Innovation Act (BPCIA), while seeking to avoid the obligations Congress established under the 2010 law "to protect innovators," Amgen Inc. and Roche AG charged in new court documents.
Sandoz is seeking the FDA's blessing to market a biosimilar version of Amgen's tumor necrosis factor (TNF) alpha inhibitor Enbrel...
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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