Drug Development
GenAI, the youngest of the AI family, is evolving quickly. The global life sciences industry is attempting to evolve with it. However, as a keynote session at DIA’s MASC suggests, taking a pause to understand AI risks and to prepare to comply with the EU AI Act is what is needed.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Jubilant Therapeutics’ differentiated, orally bioavailable molecules address both validated and novel therapeutic targets in oncology and immunology.
The biotech company is collaborating with Israel’s NeuroSense to study how the latter’s amyotrophic lateral sclerosis candidate affects plasma neurofilament levels in patients.
The company announced Monday with its second-quarter earnings that the regulator has officially halted the Phase I study after a child with acute myeloid leukemia died following treatment.
The company teased data for efinopegdutide, a GLP-1/glucagon receptor co-agonist, in nonalcoholic steatohepatitis compared to Novo Nordisk’s semaglutide, which is not yet approved for NASH.
The initial public offering on the Nasdaq is a last-ditch effort by the biotech as there is “substantial doubt” as to the company’s “ability to continue as a going concern” without the IPO, according to its SEC filing.
Data from a Phase II trial showed that Adcetris, used in a combination approach, is effective in early-stage classical Hodgkin lymphoma patients.
Valneva’s chikungunya vaccine candidate VLA1553 showed that the shot safely and rapidly induced high rates of seroprotection. Merck earlier in 2023 discontinued its chikungunya program.
The company is paying $3.2 billion upfront in cash for Chinook’s two immunoglobulin A nephropathy candidates, atrasentan and zigakibart, which will complement its own IgAN hopeful iptacopan.
Data show the potential of Editas’ sickle cell disease and transfusion-dependent beta thalassemia gene therapy candidate, but it might not be enough to overtake Vertex and CRISPR Therapeutics.
The FDA has launched a new super office to prepare for myriad decisions on cell and gene therapies, including the potential first CRISPR therapy and the first gene therapy for Duchenne muscular dystrophy.