The new stockpile builds on the Access and Allocation Mechanism established in 2024 during the mpox Public Health Emergency of International Concern (PHEIC).
The guidance recommends that Ervebo® should currently be used against Bundibugyo virus (BDBV) only within a research protocol.
AusperBio will use a significant portion of the proceeds to advance AHB 137, an antisense oligonucleotide therapy for CHB, through its Phase III registrational programme and toward potential commercialisation.
Kowa is seeking approval based on results from the pivotal Phase III Mont Blanc and Denali trials.
Photonova Spectra uses the company’s Deep Silicon detector technology to produce high-definition images while providing spectral and spatial imaging capabilities.
Cushing’s syndrome of endogenous origin occurs when the body produces excessive amounts of cortisol and other steroid hormones.
Amyl Therapeutics will expand its laboratory facilities at the LegiaPark life sciences campus in Liège, Belgium, to accommodate its growing research programme.
The acquisition will give Lilly access to Merida’s technology for developing biologics that selectively eliminate disease-causing autoantibodies.
The decision follows positive results from the Phase III VALOR trial (NCT05437263), which showed that Lisraya improved several measures of dermatomyositis disease activity.
The new site will complement RayzeBio’s existing 77,000-square-foot radiopharmaceutical manufacturing facility in Indianapolis, located about 20 miles southwest of Whitestown.