FDA Approval for LAMPRENE issued to NOVARTIS

A Mumbai tax tribunal ruled that Novartis's sale of Indian pharmaceutical trademarks was an outright transfer, not a royalty arrangement, involving 4.33 billion rupees ($46.06 million). The decision clarifies the distinction between trademark transfers and licensing.

South Korea approved Novartis' Banrapia (atrasentan) for IgA nephropathy (IgAN), a kidney disease. The drug, first in Korea for this class, targets a separate biological pathway. Approval came via the GIFT fast-track program. IgAN is prevalent in Korea, with Banrapia offering an add-on treatment. Clinical trials showed significant proteinuria reduction, but long-term kidney function benefits are still under study.

Novartis terminated its agreement with BioArctic, abandoning a neurodegeneration pact potentially worth $772M. The deal, focused on BioArctic's BrainTransporter technology, was discontinued by Novartis, according to BioArctic's release. BioArctic has other partners, including Eli Lilly, which recently paid $30M upfront for a similar deal.

Novartis terminated its 14-month-old partnership with BioArctic AB, forfeiting up to $772M in milestones. BioArctic retains a $30M upfront payment, recognizing the remainder in 2026. The termination is unrelated to BioArctic's BrainTransporter technology, according to the company. BioArctic has other collaborations with Bristol Myers Squibb and Eli Lilly.

Novartis terminated its collaboration with BioArctic on a brain-delivery technology, according to a Nov. 2 announcement. BioArctic's shares dropped over 7% in early trading. The deal, worth up to $802M, was specific to a Novartis program and did not affect BioArctic's other partnerships, including one with Eli Lilly. BioArctic will recognize remaining unrecognized upfront payment as revenue in 2026. BioArctic reported SEK 1,990M in cash and short-term investments at the end of June.

Novartis' ianalumab showed greater reductions in Sjögren’s disease activity vs. placebo at 48 weeks in two trials, per NEJM. The 300 mg monthly dose improved ESSDAI scores, but no significant differences in symptom scores. Injection reactions were more common with ianalumab.