News that Belgium's Galapagos and partner Gilead are to advance a higher dose of JAK1 inhibitor filgotinib into Phase III help allay lingering doubts over testicular toxicity with the drug, the rights to which AbbVie had unexpectedly handed back.
Galapagos NV and partner Gilead Sciences Inc. have gained US and EU regulatory endorsement for a Phase III program of their oral Janus kinase 1 (JAK1) inhibitor filgotinib that includes both the 100mg dose allowed for its Phase II program, and also a higher 200mg dose that had previously been omitted from some of its trials in humans because of concerns about testicular toxicity.
Galapagos had excluded the higher daily 200mg dose in male subjects in the US in its DARWIN Phase II program...
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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