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Novartis’ sickle cell disease therapeutic Adakveo (crizanlizumab) is under review by the European Medicines Agency’s Committee for Medicinal Products for Human Use after failing to replicate previous efficacy results in a Phase III trial.
“As we invest to scale production of our commercial biomaterial products to meet expected demand in the United States and the Middle East, we are prioritizing our most promising cell therapy product candidates and programs and are rebalancing our workforce and identifying targeted expense reductions to support these priorities,” said CEO Robert J. Hariri.
The FDA approved Merck’s Keytruda for the treatment of stage IB, II or IIIA non-small cell lung cancer after resection or platinum-based chemotherapy.
Following the death of a patient, Magenta Therapeutics placed a hold on Phase I/II dose-escalation trial of its acute myeloid leukemia therapy.
A biotech company focused on short-duration psychedelic-assisted therapies for mental health conditions announced positive top-line results from the first placebo-controlled efficacy study exploring a short-duration psychedelic for the treatment of major depressive disorder.
A group of 25 senators, led by Sen. Elizabeth Warren (D-MA), requested that HHS Sec. Xavier Becerra exercise march-in rights for Xtandi, a prostate cancer therapeutic. March-in rights give the government the right to take a license for itself if it helped to fund the product owner’s research.
The FDA’s Peripheral and Central Nervous System Drugs advisory committee will discuss the merits of Biogen and Ionis’s ALS candidate tofersen on March 22nd.
Company president and CEO Bernard Coulie, M.D., Ph.D. called the data “unprecedented in IPF clinical drug development”.
J&J’s Janssen terminated its integrin research collaboration with Morphic Therapeutics. This follows the June 2022 termination of a partnership with AbbVie.
Findings from the pivotal Phase III NAPOLI 3 trial show Ipsen’s Onivyde (irinotecan liposome injection), when used as part of the investigational NALIRIFOX regimen, boosted overall survival in metastatic pancreatic ductal adenocarcinoma, the company announced Friday.
