Phase III
At ENDO 2022, Ascendis will share Phase II and III data showing clinical efficacy for its investigational product candidate for hypoparathyroidism. For this and more, see inside.
Results of the Phase III trial showed that Evusheld protected against progression to severe COVID-19 or death in the early outpatient treatment of mild-to-moderate COVID-19.
Aldeyra Therapeutics reported that its reproxalap hit the mark in the Phase III Tranquility-2 study for dry eye disease. The drug showed statistical superiority for its two primary endpoints.
The approval expands the rapidly growing number of indications for Dupixent, which is the first and only biologic medication with the FDA’s nod to treat atopic dermatitis from infancy to adulthood.
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.
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.
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.
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