Exalenz Of Israel, Pfizer Of U.S. In Deal With FDA-Approved Test Kit
Israel's Exalenz Bioscience has signed a replacement deal with U.S.-based Pfizer to use the BreathID noninvasive diagnostic kit to test Pfizer drugs for treating gastrointestinal disorders
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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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Recent moves in the industry include changes at the top at Novo Nordisk and Takeda, plus Nxera Pharma nabs chief commercial officer from AstraZeneca.
China’s imposed large retaliatory tariffs on US pharmaceuticals on 10 April, but some domestic firms with in-licensed, US-origin assets were already moving to localized manufacturing.
The end of semaglutide and tirzepatide shortages means large-scale compounding is declining, ICER noted. But compounded versions – and the demand for them – are likely here to stay.