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Active pharmaceutical ingredient (API) manufacturer Bioiberica of Barcelona, Spain, was hit with a warning letter from the FDA for problems with contamination and lack of process controls. Read More
Labeling for proposed ready-to-use products that contain a range of drug strengths in a single container should contain instructions for determining the correct dose to be administered based on a patient’s weight or body surface area (BSA), according to a new FDA draft guidance. Read More
More than 180 House lawmakers have sent a letter to the Biden administration pressuring the Department of Health and Human Services (HHS) to penalize companies that limit 340B drug discounts — the latest move in an ongoing tussle between drugmakers and the U.S. government. Read More
The proprietary therapy “has the potential to significantly advance the treatment of gliomas,” says Vijay Agarwal, the company’s founder and CEO, who is a practicing brain tumor surgeon. Read More
Novo Nordisk is going after Biocon Pharma, claiming patent infringement over a generic version of Novo’s weight loss drug Saxenda (liraglutide injection), a glucagon-like peptide-1 (GLP-1) receptor agonist. Read More