Drug Development
Yescarta is the first treatment in nearly 30 years to improve overall survival in relapsed/refractory large B-cell lymphoma R/R LBCL, according to Gilead’s Kite Pharma.
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
The American Society of Clinical Oncology and the Association of Community Cancer Centers are combining their efforts to increase racial and ethnic diversity in clinical trials.
Several biopharma companies are opening the week with positive clinical trial news. Read on for updates from Cytokinetics, Concert Pharmaceuticals, Idorsia and Seagen.
Burlingame, CA-based Innoviva is buying all of Waltham, MA-based Entasis Therapeutics’ available shares at $2.20 per share. Currently, Innoviva owns about 60% of Entasis’ outstanding shares.
Biohaven Pharma’s NDA for its nasal spray zavegepant was accepted by the FDA, while Phase III results for its drug troriluzole to treat spinocerebellar ataxia were disappointing.
Lifting the clinical hold will allow Ocugen to continue to assess the vaccine in its ongoing study and potentially support its efforts to achieve EUA or full approval.
A small research study published in Jama shows people with a lower body mass index (BMI) tended to maintain immunity against COVID-19 longer.
Regeneron Pharmaceuticals shared positive results from its Phase III trial of an evinacumab for children with homozygous familial hypercholesterolemia.
Vir Biotechnology terminated a two-year-old COVID-19-related antibody collaboration with Wuxi Biologics that included sotrovimab, which lost EUA in the U.S. earlier this year.
Based on topline data, Pfizer stated that three doses of the COVID-19 vaccine met all immunobridging criteria required for EUA. The FDA’s advisory committee will meet June 15 to discuss the matter.
Elicio Therapeutics published data on the preprint server bioRxiv, describing preclinical research into its cancer vaccine that shows a lot of promise.