Drug Development
Despite the Phase III failure, Travere and partner CSL Vifor will explore potential regulatory paths for sparsentan as a treatment for focal segmental glomerulosclerosis.
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 FDA granted Breakthrough Therapy Designation to Verttex’s candidate inaxaplin (VX-147). for the treatment of APOL1-mediated focal segment glomerulosclerosis.
Moderna announced its Omicron-containing COVID-19 booster candidate, mRNA-1273.214, demonstrated superior antibody response against Omicron in its Phase II/III study.
Annexon released final data from an open-label phase II clinical trial, showing that its drug candidate ANX005 safely stabilized disease progression in patients with Huntington’s disease.
The Tisch MS Research Center of New York has been researching the concept of using cell therapy as a therapeutic strategy to promote repair and regeneration in certain patients with MS.
On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention to recommend authorization of Novavax’s COVID-19 vaccine.
Seres Therapeutics, Inc. announced that the company’s Phase III Ecospor IV study demonstrated a strong safety profile in addition to statistically significant positive results against C. difficile infection.
The Phase I mechanism of action study, showing that Lilly’s injectable Mounjaro (tirzepatide) induces greater weight loss than placebo and Novo Nordisk’s semaglutide in adults with type 2 diabetes.
Powered by its blockbuster checkpoint inhibitor Keytruda, Merck is forecasting a potential of more than 80 new regulatory approvals in oncology through 2028.
The Phase III ADvocate 1 and 2 studies on lebrikizumab showed that eight out of 10 patients with atopic dermatitis maintained skin clearance in the 12 months they had been under treatment.
BioSpace caught up with Tara Frenkl and Nelson Ambrogio ahead of ASCO to discuss Bayer’s goal of becoming a top 10 oncology company by 2030.