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MacuCLEAR's lead molecule for AMD, based on a marketed anti-hypertensive, stimulates choroidal blood flow so that cellular wastes in the eye can be cleared and never cause the breakdown of critical tissues that diminish vision. The company has received IND clearance to shepherd its treatment down the 505(b)(2) approval pathway with fast track status.
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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
Dr Reddy’s CEO discusses the growth opportunity for semaglutide, including production capacity and ‘crazy’ demand indications, and a potential 20-plus product GLP-1 portfolio. All eyes are also on an upcoming hearing in India pertaining to Novo Nordisk’s semaglutide patent in the country.
Deal Snapshot: The addition of Hengrui's HRS-9821, a China-originated fast-follower of Verona’s Ohtuvayre in chronic obstructive pulmonary disease, should enable GSK’s COPD therapy portfolio to stack up well against increasing competitors in the indication, including biologics and small molecules.
In this week's episode: Sanofi’s Vicebio buy; Sarepta halts US Elevidys shipments; Novartis warning over Europe; US CRL for Genentech’s Columvi; and an interview with Novavax.