The lack of data surrounding the efficacy of Chinese COVID-19 vaccines against the Delta variant has had many questioning them, especially after a recent study showed that one of those vaccines, Sinovac Biotech Ltd.’s Coronavac, was less effective than Pfizer Inc. and Biontech SE’s Comirnaty in Chile.
Approval could come next year for Furoscix from Scpharmaceuticals Inc. (Scpharma), a solution of the standard-of-care heart failure diuretic furosemide formulated to a neutral pH and designed for outpatient use.
All the primary endpoints were met in Hepion Pharmaceuticals Inc.’s phase IIa trial of CRV-431 for treating nonalcoholic steatohepatitis (NASH). The market, however, wasn’t celebrating as the Edison, N.J.-based company’s stock (NASDAQ:HEPA) sagged 15.27% on July 13 to close at $1.72 per share.
Safety will be the focus July 15 when the FDA’s Cardiovascular and Renal Drugs Advisory Committee dives into the data for Fibrogen Inc.’s roxadustat as a treatment for anemia due to chronic kidney disease.
Europe’s clinical trial registry is a mess with patchy and incomplete data, according to a scathing review of the system from researchers based at the U.K.’s University of Oxford, who hope that a revamp at the end of the year could improve matters.
DUBLIN – Inotrem SA has received €45 million (US$53 million) in public funding commitments to move its Trem-1 inhibitor, nangibotide, into a phase II/III trial in COVID-19 patients who are critically ill and on ventilation.
Riding high on dramatic phase Ib results with KIT receptor-binding monoclonal antibody CDX-0159 in urticaria (hives), Celldex Therapeutics Inc. plans to begin phase II work in the first half of next year. Shares of Hampton, N.J.-based Celldex (NASDAQ:CLDX) closed July 12 at $40.67, up $8.26, or 25%, as Wall Street reacted to favorable data from the trial in antihistamine-refractory cold urticaria and symptomatic dermographism, the two most common forms of chronic inducible urticaria (CindU).
RSS
