Drug Development
Phase IIa data showed AI Therapeutics’ ALS candidate increased expression of a target engagement biomarker and led to a 73% reduction in a toxic protein aggregate.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
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.
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THE LATEST
A largely untested and unproven treatment for Alzheimer’s disease, called transcranial pulse stimulation (TPS), is becoming popular around the world, although experts are skeptical.
Eligo Bioscience has thought of a way to solve the dysbiosis between our bodies and our microbiomes – gene editing. BioSpace spoke with Eligo Co-founder and CEOXavier Duportet, Ph.D.
Several new biotech and biopharma companies are sharing their strengths to develop new treatments for high-need diseases diabetes, Alzheimer’s and cancer.
The FDA has issued special designations that could improve the lives of millions with recurrent glioblastoma or hemophilia diagnoses.
Axsome Therapeutics published results of its Phase III trial of AXS-05 that demonstrated rapid, substantial and statistically significant improvement in depressive symptoms.
Bristol Myers Squibb (BMS) has announced late-breaking data showing deucravacitinib significant efficacy at the primary endpoint for the treatment of systemic lupus erythematosus (SLE).
Sage Therapeutics and partner Biogen shared news that their phase III Skylark study has yielded promising results for women suffering from severe postpartum depression (PPD).
The U.S. FDA has requested some additional data from BioMarin Pharmaceuticals for the BLA it filed for the hemophilia A therapy valoctocogene roxaparvovec.
Eledon Pharmaceuticals announced positive topline results from its Phase IIa clinical trial evaluating tegoprubart in patients with amyotrophic lateral sclerosis (ALS).
The FDA has decided to extend the Prescription Drug User Fee Act (PDUFA) review date for TG Therapeutics’s ublituximab until December 2022.