The European Commission has officially approved Luxturna, Novartis/Spark Therapeutics’ transformative gene therapy. The Swiss firm tells Scrip how the lessons it expects to learn from launching its first gene therapy will inform its future strategy in this new field.
The European Commission has officially approved Luxturna (voretigene neparvovec), Novartis AG’s one-time gene therapy for inherited retinal dystrophy caused by RPE65 gene mutations.
This is the company’s first move into gene therapy and the approval is something of a landmark for Novartis. What...
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
