Months after a disappointment in Duchenne muscular dystrophy, the US firm’s pamrevlumab has missed the mark in a pivotal idiopathic pulmonary fibrosis trial, boding poorly for other trials and forcing the firm to enter cost-cutting mode.
Pamrevlumab missed the primary endpoint of change in forced vital capacity versus placebo.
FibroGen, Inc.’s monoclonal antibody candidate pamrevlumab has disappointed in the Phase III ZEPHYRUS-1 trial in idiopathic pulmonary fibrosis (IPF), rendering the drug’s future prospects even more uncertain and triggering cost-saving measures.
FibroGen said it would terminate a second ongoing Phase III trial in the same indication – ZEPHYRUS-2 – as the...
Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.
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.
The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.
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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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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