Katama Pharmaceuticals Inc. was built around tolperisone, a generic, oral small molecule muscle relaxant manufactured and sold in Europe for the treatment of muscular pain and neuromuscular spasms. Katama aims to launch its version in the US, initially for treating acute lower back pain.
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
Abeona plans to offer an outcomes-based payment model for Zevaskyn, which likely will see complementary use with Krystal’s Vyjuvek in recessive dystrophic epidermolysis bullosa patients.
CEO Len Schleifer explained on the company’s Q1 earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.
CEO Vas Narasimhan urged European governments to spend more to support drug innovation during Novartis's first-quarter results call.
