Complete response letter follows July deficiencies letter that made approval seem highly unlikely. Vanda called the setback perplexing and said it plans to continue working to get jet lag disorder added to the Hetlioz label.
The US Food and Drug Administration’s complete response letter for Vanda Pharmaceuticals Inc.’s Hetlioz in jet lag disorder was expected by nearly everyone except the company itself, which said on 19 August that it is “perplexed” by the agency’s assertion that the clinical data backing the sNDA are of “unclear clinical significance.”
The Washington, DC-based firm said it received the CRL on 16 August, which had been the action date for the...
The Swiss pharma company is rebalancing the portfolio, emphasizing best-in-class drugs and moving into new areas like cardiovascular and metabolic disease.
In this week's episode: Trump’s UK drug pricing win; Novo explains semaglutide Alzheimer's rationale; J&J and Novartis on this year’s biggest M&A deals; a look at the mixed performance of CAR-Ts; and Akeso’s goals beyond ivonescimab.
Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
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.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
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