Kicking off this year’s American Academy of Neurology annual meeting on Friday morning, AbbVie shared more positive results for its migraine drug, Qulipta (atogepant). Originally approved in 2021 for the preventative treatment of episodic migraine headaches, AbbVie has continued to…
FDA approves allogeneic stem cell transplant therapy
The first allogeneic stem cell transplant therapy to be approved based on Phase III study results has been granted by the US Food and Drug Administration (FDA). Omisirge® (omidubicel-onlv), now US Food and Drug Administration (FDA) approved, is the…
FDA approves first new B-cell lymphoma treatment in 20 years
A first-line B-cell lymphoma treatment shown to reduce the risk of disease progression or relapse by 27 percent has been approved by the FDA. The US Food and Drug Administration (FDA) has approved Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan®…
Vertex/CRISPR file first gene-editing therapy with FDA
Vertex Pharma and CRISPR Therapeutics have become the first companies to file for FDA approval of a therapy based on gene-editing technology. The two partners have submitted a marketing application exagamglogene autotemcel (exa-cel, formerly CTX001) for blood disorders sickle cell…
Novo Nordisk, Aspect sign $2.6bn diabetes cell therapy deal
Novo Nordisk has put $75 million down on the table to partner Canadian biotech Aspect Biosystems’ cell-based therapies for diabetes and obesity. The upfront payment is backed by up to $650 million in milestones for each product that arises from…
AIM secures approval for post-Covid conditions (long Covid fatigue) therapy trial protocol
The trial aims to include around 80 subjects within the age group of 18 to 60 years at up to 10 sites in the US. AIM ImmunoTech has received approval from the central Institutional Review Board (IRB) in the US…
Lung organoids could replace animal testing and boost success in clinical trials
Scientists have developed a step-by-step blueprint to create advanced human lung models in the lab, which they say will accelerate the discovery and development of new drugs and reduce reliance on animal testing. The research due to be published in…