SironRX Therapeutics Inc. is betting that a product encoding a protein naturally produced by the body in response to tissue injury, and known to recruit stem cells, can become a drug effective at healing wounds and preventing skin scarring. The start-up got rights to Stromal cell-Derived Factor-1 from Juventas Therapeutics and Cleveland Clinic.
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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
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Cipla’s partnered filgrastim biosimilar is expected to debut in the US in Q2 FY26 and the Indian firm expects an investment return ratio for its biosimilar engine “not too far” from that of a complex generic product amid an enabling regulatory environment.
Celltrion is set to acquire a US biologics manufacturing facility that will "eliminate" its US tariff risks and provide a ready-made production base for future expansion.
