Successful entry into the nascent US biosimilars market is fraught with unknowns, but an analysis by independent research service BioMedTracker concludes that aspiring big pharma would be well advised to partner early, ideally when the drug is in development outside the US, and to use the 351(k) abbreviated pathway to get the quickest regulatory approval.
Successful entry into the nascent US biosimilars market is fraught with unknowns, but an analysis by independent research service BioMedTracker concludes that aspiring big pharma would be well advised to partner early, ideally when the drug is in development outside the US, and to use the 351(k) abbreviated pathway to get the quickest regulatory approval.
"In observing partnerships signed over the past 15 years we found that there is a strong incentive to partner early...
Optimizing Drug Pipelines With Biophysical Methods”, your view into how using biophysical techniques can enhance and streamline processes throughout the drug discovery and validation cycle.
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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Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
