Import Safety Agreement Further Entwines FDA/China Regulatory Process
Chinese manufacturers of certain drugs or active pharmaceutical ingredients selected by FDA will have to meet new registration standards as part of a memorandum of understanding signed Dec. 11 in Beijing by HHS, FDA and China's State Food and Drug Administration
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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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The company reported positive topline results for ASCENT-04, which also bode well for the ASCENT-03 trial in patients with low PD-L1 expression.
Merck’s immuno-oncology blockbuster was the world’s best-selling drugs by revenues for the second year in a row, with an almost $12bn lead over its closest rival, Novo Nordisk’s GLP-1 drug Ozempic.
AstraZeneca and Daiichi’s DESTINY-Breast09 trial testing Enhertu with pertuzumab versus standard of care showed a statistically significant and meaningful PFS improvement.