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Generics of Complex Drugs Must Pass Korea FDA's Bioequivalence Test; Another Positive Development for MNCs
SEOUL - Korea's Food and Drug Administration will soon require medicines made by Korean generic drug makers to pass the agency's bioequivalence test when producing copies of branded originals with more than two active ingredients, also known as complex drugs
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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.
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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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The company has presented the full set of positive results from the Phase IIb ANTHEM-UC trial in the inflammatory bowel disease.
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Japan's latest Nobel Prize win sparks hopes for renewed investment in biopharma R&D by the national government, including in a venture co-founded by the winner.