Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval.
CAR T-cell immunotherapy is designed with different targets depending on the receptors they will bind to. CARs can also contain different tools, like the concept of a Swiss army knife, with several utensils for different tasks. The goal is to make them more effective and durable. During the second session of the Spotlight on Immuno-Oncology conference, “Novel CAR designs and approaches,” Robbie Majzner, of Stanford University, described expanding the main components of CAR T cells to acquire new functions and act on different cell pathways.
A study of the genetic determinants of HIV viral load in 3,879 people of African ancestries has found what is claimed to be the only new variant related to HIV infection discovered in more than two decades of research into how host genomics affects the response to the retrovirus.
“From such a stick, such a splinter,” is a popular Spanish saying to explain how a son resembles his father. Like father, like son. The first Spotlight on Immuno-Oncology conference of the American Society of Gene & Cell Therapy (ASGCT) is the splinter of the ASGCT annual meeting, which brought together a group of experts in this field. It took place on Aug. 1 and 2, 2023, starting with a series of talks on “B Cell Malignancies and Beyond.”
Despite a newly signed $645 million commercialization deal with Neuraxpharm Group for multiple sclerosis drug Briumvi (ublituximab) in Europe, shares of TG Therapeutics Inc. (NASDAQ:TGTX) tanked by 49.3% on Aug. 1 due to a perceived miss in U.S. net sales for the anti-CD20 monoclonal antibody during its first full quarter on the U.S. market.
Heteroaryl compounds acting as interleukin-1 receptor-associated kinase 4 (IRAK-4) inhibitors are described in a recent Accro Bioscience (HK) Ltd. patent. They are reported to be useful for the treatment of endometriosis, systemic lupus erythematosus, multiple sclerosis, psoriasis, rheumatoid arthritis, primary central nervous system and diffuse large B-cell lymphoma.