All articles by Manish Kumar
Manish Kumar
FDA approves Amgen’s Lumakras with Vectibix for colorectal cancer
The agency has also approved the therascreen KRAS RGQ PCR Kit as a companion diagnostic to identify KRAS G12C-mutated colorectal cancer patients eligible for Lumakras and Vectibix
Charles River and Akron Bio partner to enhance operations with integration of CGMP materials into cell therapy platform
The integration of Akron’s line of liquid cytokines further enables closed system processing, which streamlines operations, minimizes risk, and improves process robustness
Lyndra Therapeutics partners with Thermo Fisher for long-acting therapies
Thermo Fisher will provide clinical research and commercial manufacturing services for Lyndra’s Phase 3 study and long-acting oral therapies using the LYNX platform
Incyte and Syndax announce US FDA approval of Niktimvo 9 mg and 22 mg vial sizes
Niktimvo is the first and only approved treatment for chronic GVHD that targets CSF-1R to reduce the drivers of inflammation and fibrosis
Johnson & Johnson to acquire Intra-Cellular Therapies for $14.6bn
The pharma major will gain access to Caplyta for schizophrenia, bipolar depression, ITI-1284 for GAD and Alzheimer’s, and a complementary clinical-stage pipeline
Lilly to acquire Scorpion Therapeutics’ mutant-selective PI3Kα inhibitor program
The acquisition will expand Lilly’s oncology pipeline with STX-478, the differentiated and potentially best-in-class, mutant-selective PI3Kα inhibitor currently in a Phase 1/2 clinical trial
Telix to acquire ImaginAb’s therapeutic assets for up to $230m
The agreement includes ImaginAb’s therapeutic pipeline, biologics platform, and protein engineering research facility to enhance Telix Pharmaceuticals’ innovation capabilities
Iktos and Cube Biotech announce launch of small molecule AI drug discovery collaboration
Partnership will leverage Iktos’s AI-enabled drug discovery platform and Cube Biotech’s advanced protein technologies to develop novel agonists of the Amylin Receptor
Health Canada approves Vyloy for first-line gastric cancer treatment
The approval was based on results from the Phase 3 SPOTLIGHT and GLOW trials, in which zolbetuximab improved progression-free and overall survival in gastric or GEJ cancer patients
Nipocalimab granted US FDA Priority Review for the treatment of generalized myasthenia gravis
Biologics License Application acceptance supported by results from the Phase 3 Vivacity-MG3 study