Manufacturing Brief
Having secured deals with AstraZeneca and Novartis, Niowave is constructing a second facility to meet rising demand for actinium-225, which can be used to develop next-generation radiopharmaceuticals.
The agreement is the largest in a series of deals that Gilead Sciences has penned with Korea’s Yuhan.
By partnering with a UN-backed body, Roche has enabled companies to make the medicine for supply in 129 countries.
While the manufacturer is on the list of authorized GLP-1 importers, FDA inspectors found the company relabeled APIs from another site in a potential attempt to “circumvent safeguards.”
Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
A batch of a chemotherapy product made at a Sun facility with a history of quality and compliance issues is being withdrawn from the U.S. market.
MacroGenics is selling the manufacturing plant to Bora, a Taiwan-based CDMO, to raise cash to support the progress of its drug development pipeline.
While Daiichi Sankyo brought in $13.4 billion in 2025, setbacks forced the company to update its antibody-drug conjugate forecast, pushing demand below the minimum supply agreed upon with CMOs and prompting the cancellation of an in-house investment.
Eli Lilly’s latest manufacturing expansion will support production of obesity blockbusters and next-gen assets, while the new Lilly Lebanon Advanced Therapies site will take experimental genetic medicines from research to commercialization.
Implemented as part of a broader initiative to make more targeted and efficient use of inspection resources, the pilot program will use artificial intelligence to enable shorter, focused screenings to complement standard FDA inspections.
PRESS RELEASES