The FDA has classified the action as a Class II recall, indicating that the affected product may cause temporary or medically reversible adverse health effects, although the likelihood of serious health consequences remains low.
The approval authorises the company to collect plasma in Indonesia and process it through its global manufacturing network while the country develops its own plasma infrastructure.
The setback comes at a crucial time as competition intensifies in the fast-growing market for lower-cost versions of Novo Nordisk’s blockbuster diabetes and obesity medicine.
The agreement gives Apollo-managed funds and affiliates a non-controlling interest in a newly created entity that will hold Bayer’s LARC portfolio.
MindRank developed MAP as an AI-native drug discovery engine that combines computational biology, chemistry, laboratory experiments and clinical data into a single research platform.
Evonik will use the funding to upgrade major production assets, including large reactors and other critical processing systems.
Under the agreement, researchers will gain access to an integrated platform that combines Evogene’s AI-powered computational chemistry engine, ChemPass AI, with the BCDD’s laboratory infrastructure and drug discovery expertise.
The Nottingham site also supports Codis’ commercial spray-drying operations in Haverhill, U.K., where the company is increasing capacity by installing a new GEA Pharma-SD PSD-4 commercial spray dryer, with validation planned for 2027.
The EC signed the framework agreement after a request from six participating countries, including Austria, Denmark, Ireland, Luxembourg, Norway, and Portugal.
Under the agreement, Novo Nordisk will internally assess Vivani’s investigational NPM-139 implant, which utilizes the company’s proprietary NanoPortal technology to deliver semaglutide continuously over extended periods through a miniature subdermal device.