The firm’s BTK inhibitor tolebrutinib has been put on clinical hold by the US FDA following liver injuries, but advanced trials should continue as normal since most patients have passed the 60-day mark.
Sanofi has hit a regulatory road bump as the US FDA placed its MS candidate tolebrutinib on clinical hold following concerns over liver toxicities, but strong enrollment numbers mean impact on studies should be limited.
The US Food and Drug Administration placed a partial clinical hold on Phase III studies of tolebrutinib in multiple sclerosis...
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.
To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.
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.
![Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]](https://web.insights.norstella-labs.com/resizer/v2/3M7ZAWZOBNK7NG4A4WDOIFG6DU.jpg?smart=true&auth=392a1fdb3cfacb29445720c412410e598dbcc5f90f14857652cd498bd0faa0fb&width=400&height=225)