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Newly-launched Massachusetts biomanufacturing facility will be something like a conveyor belt from the academic bench to the early startup.
GSK is pulling the plug on an experimental monoclonal antibody therapy for rheumatoid arthritis following a significant miss in one of three Phase III trials.
The FDA has upheld the accelerated approval of Jazz Pharmaceuticals’ Zepzelca (lurbinectedin), even though the drug failed to reach its primary endpoint in the confirmatory Phase III ATLANTIS trial.
Alnylam Pharmaceuticals released its report for Q3, in which the company stated it will no longer initiate a Phase III trial for vutrisiran in Stargardt disease.
Two Phase III trials of Genentech (Roche)'s Vabysmo hit the primary endpoint in macular edema caused by branch and central retinal vein occlusion, showing non-inferiority to Regeneron’s Eylea.
Minneapolis-based DiaMedica Therapeutics plans to conduct additional studies in order to resolve a clinical hold on its DM199 program for the treatment of acute ischemic stroke (AIS).
Candel revealed a collaboration with the University of Pennsylvania to assess the combination of Candel’s viral immunotherapy and UPenn’s CAR-T cell treatments in solid tumor models.
With diagnostics for Alzheimer’s already approved and therapeutics in late-stage clinical trials, the next hurdle is to translate these advances into clinical practice. The Davos Alzheimer’s Collaborative is working on it.
VitroLabs Inc, the California based biotech company leading the commercialization of cell cultivated animal leather, announces the appointment of two new members to its Board of Directors
The FDA’s Oncologic Drugs Advisory Committee voted unanimously against approving l-omburtamab for children with a rare form of neuroblastoma, citing complex review issues.
Merck, Bristol Myers Squibb, Biogen and others presented their latest data from MS programs at the 38th ECTRIMS conference.
An FDA adcomm that met Wednesday to vote on GlaxoSmithKline’s daprodustat for adult patients with anemia due to chronic kidney disease (CKD) produced mixed results.
