Isatuximab could be the next building block in Sanofi's ambitions to rebuild in oncology. The CD38-targeting antibody extended PFS in relapsed/refractory multiple myeloma in combination with Celgene's Pomalyst and dexamethasone.
Sanofi's CD38-targeting antibody isatuximab could be the company's next new cancer drug as it looks to rebuild in oncology. The pharma said Feb. 4 that it will file isatuximab with regulatory authorities in the US and Europe in the first half of 2019 based on the positive results from a Phase III trial in relapsed/refractory multiple myeloma (r/rMM).
But isatuximab, if approved, will be in a come-from-behind position following Johnson & Johnson/Genmab AS's Darzalex (daratumumab), which...
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.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
