Mogamulizumab has met its primary survival endpoint in a comparative Phase III trial in cutaneous T-cell lymphoma, positioning the Kyowa Hakko Kirin product as a potential close follower to Adcetris in the second-line setting.
Kyowa Hakko Kirin Co. Ltd. says it plans to initiate discussions with regulatory authorities this year about pursuing marketing authorizations for mogamulizumab in cutaneous T-cell lymphoma (CTCL), following just-released positive top-line results from a comparative Phase III trial.
The new findings position the CCR4-targeting antibody as a likely “close follower“ in the CTCL setting to Adcetris (brentuximab vedotin),...
The CEO of South Korean biotech shares how his company was able to reach a partnership with Rani so quickly and why it is confident in its GLP-1/GLP-2 dual agonist for obesity and diabetes, despite recent disappointing clinical results for its sole rival.
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.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
