Clearant Inc. eventually aims to apply its gamma pathogen inactivation technology to the blood transfusion market, but it is starting with sterilization of tissue implants and other biological products where the regulatory hurdles are lower and the timeline to commercialization is shorter.
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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
South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.
Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.
Spero and partner GSK have Phase III non-inferiority data to support approval of tebipenem as the first oral antibiotic for complicated urinary tract infections.
