July 24 Company Quick Takes: Samsung's Humira biosimilar gets FDA approval; plus Intra-Cellular, Sage and more
FDA approves Samsung's Humira biosimilar
Samsung Bioepis Co. Ltd. (Incheon, South Korea) said FDA approved Hadlima adalimumab-bwwd, a biosimilar of autoimmune drug Humira from AbbVie Inc. (NYSE:ABBV). Samsung's partner Merck & Co. Inc. (NYSE:MRK) will begin marketing the drug in the U.S. on June 30, 2023, per a licensing agreement with AbbVie.
Intra-Cellular clarifies committee meeting cancellation
In response to the cancellation of a July 31 FDA advisory committee meeting to discuss the NDA for schizophrenia candidate lumateperone, Intra-Cellular Therapies Inc. (NASDAQ:ITCI) said the agency needed more time to review new information it had provided regarding non-clinical studies. The company said the candidate's Sept. 27 PDUFA date could be extended...