SINGAPORE – Novartis announced today that the Health Sciences Authority (HSA) has approved Kymriah (tisagenlecleucel) as the first commercial chimeric antigen receptor T-cell (CAR-T) therapy in Singapore under the new cell, tissue and gene therapy products (CTGTP) regulatory framework. Kymriah, a CD19-directed genetically modified autologous T-cell immunocellular therapy, is approved to treat two...
treatment News
Basel — Novartis announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted the company’s Supplemental Biologics License Application (sBLA) and Type II Variation, respectively, for Kymriah® (tisagenlecleucel) in adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two prior lines...
Basel — Novartis today reported the final analysis from the NETTER-1 phase III study comparing treatment using Lutathera® (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) plus 30 mg octreotide LAR to 60 mg of octreotide LAR in patients with midgut neuroendocrine tumors. The previously reported primary analysis...
Basel — Novartis announced today that the CANOPY-1 Phase III study did not demonstrate the statistically significant primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients treated with canakinumab (ACZ885) combined with pembrolizumab plus platinum-based doublet chemotherapy, compared to patients receiving placebo in combination with pembrolizumab plus...
BASEL, Switzeland – The FDA on Wednesday approved Novartis’ oral drug iptacopan, a Factor B inhibitor now to be marketed under the brand name Fabhalta, for the treatment of adults with paroxysmal nocturnal hemoglobinuria. Designed to be orally available, Fabhalta is a small molecule inhibitor of Factor B, a key...
Basel, Switzerland – This week Novartis released topline results from the Phase III APPEAR-C3G study showing that its oral factor B inhibitor iptacopan significantly reduced protein in the urine of patients with C3 glomerulopathy, an ultra-rare and progressive kidney disease. In APPEAR-C3G, twice-daily treatment with 200-mg iptacopan—when given on top...
Basel, Switzerland – A new way to treat a painful skin condition shows promise in a phase 2 trial, according to a late-breaking presentation at the American Academy of Dermatology (AAD) Association annual meeting. Novartis’ remibrutinib was well tolerated and showed high responder rates compared with placebo in patients with...
CHICAGO – A newly developed artificial intelligence (AI) system that analyzes specialized MRIs of the brain accurately diagnosed children between the ages of 24 and 48 months with autism at a 98.5% accuracy rate, according to research being presented next week at the annual meeting of the Radiological Society of...
Sendai, Japan – Researchers at Tohoku University have discovered a new approach for treating lymph node metastasis. Anticancer drugs are administered directly into the LNs under ultrasound guidance (Lymphatic Drug Delivery System or LDDS) to target sentinel lymph nodes (LNs) and generate antitumor effects locally, preventing distant metastasis. This approach...
CHICAGO – A newly developed artificial intelligence (AI) system that analyzes specialized MRIs of the brain accurately diagnosed children between the ages of 24 and 48 months with autism at a 98.5% accuracy rate, according to research being presented next week at the annual meeting of the Radiological Society of...