Data Exclusivity Remains A Top Issue In U.S. Trade Representative's 2011 Special 301 Report
The failure of U.S. trading partners to adequately protect pharmaceutical test data remains one of the top concerns of the United States Trade Representative in its 2011 Special 301 Report on intellectual property rights
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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 C-suite changes at Essential Pharma, plus Kyverna Therapeutics gets new chief financial officer from Alector.
The Swiss company believes its platform can make radiopharmaceuticals easier to produce and more accessible to patients.
Lupin's choice of a Cimzia biosimilar candidate and partnering with Zentiva reflect a strategy to sort the wheat from the chaff. Of 118 biologics to lose patent protection between 2025 and 2034 as per IQVIA, it’s going for a biosimilar with a single competitor though there could be other spoilers