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US Food and Drug Administration (FDA)
Using a natural language-inspired technique, researchers at the University of Central Florida, US, developed an interpretable and generalisable drug target interaction model that achieves 97 percent accuracy in identifying drug candidates for a broad variety of target proteins. Here, Dr Ozlem Ozmen Garibay and Aida Tayebi, who worked on the…
The FDA has cleared the Simcere's investigational new drug application for SIM0237, an anti-PD-L1/IL-15 bi-functional fusion protein, for the treatment of adult patients with advanced solid tumours.
Incannex Healthcare has completed a pre-IND meeting with the FDA for IHL-216A, a drug product for treatment of traumatic brain injury.
Following FDA clearance, Cellenkos will initiate Phase I and Phase Ib trials of CK0803, allogeneic regulatory T cells, in patients with ALS.
Drug-initiated activity metabolomics screening discovers the metabolite myristoylglycine, that converts white fat cells to brown fat cells.
Decibel Therapeutics has submitted an IND application for a Phase I/II trial of DB-OTO, a gene therapy candidate to restore hearing.
Silo Pharma says it is preparing a pre-IND package and meeting with the FDA for a topical formulation of ketamine to treat fibromyalgia.
Clarametyx says the FDA has accepted an IND application for first-in-human trials of CMTX-101, an antibody to treat bacterial pneumonia.
A geometric deep-learning model is faster and more accurate than state-of-the-art computational models, reducing the chances and costs of drug trial failures.
In this Q&A, Immunexpress Chief Executive Officer Dr Rolland Carlson and Chief Scientific Officer Dr Richard Brandon discuss key aspects for molecular diagnostic discovery and development platforms, including how to best leverage microarray and next-generation sequencing (NGS) tools.
The endocannabinoid system may play a role in the development of autism spectrum disorder and might be key to treating people with severe forms of the condition. In this commentary, Dr Karen Litwa, Assistant Professor at East Carolina University’s Brody School of Medicine, US explores how a bioelectronic assay is…
Viral vectors to deliver gene therapies are utilised by clinically approved therapies. However, this method is not the only option for advanced therapeutics. In this piece, Brent Warner, President, Gene Therapy at Poseida Therapeutics, discusses the balance between efficacy and safety in gene therapy, highlighting positive pre-clinical data for non-viral…
While the full potential of gene therapies continues to be realised, their successes in rare diseases promote them as a promising treatment modality. Dr Gaurav Shah, Chief Executive Officer of Rocket Pharmaceuticals discusses the future of gene therapies as well as the company’s progress in in vivo and ex vivo programmes.