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Sandoz received bad news Tuesday when a federal appeals court affirmed the FDA’s decision to deny its challenge and grant Sanofi the exclusive right to market the blockbuster multiple sclerosis drug Aubagio. Read More
India-based Biocon Biologics has received a Complete Response Letter (CRL) from the FDA calling for more data on its biologics license application for a form of regular insulin (insulin-R) and evidence the company has resolved manufacturing problems uncovered in a preapproval inspection. Read More
Indian generics company Sun Pharmaceutical Industries took another hit from the FDA, receiving an FDA warning letter after the company failed to adequately address the agency’s concerns over lapses in aseptic procedures, inadequate media fills, poorly designed and ventilated cleanrooms, and flaws in vial-filling machinery. Read More
More than two dozen lawmakers are asking HHS Secretary Xavier Becerra to lower the cost of Xtandi (enzalutamide), a pricey androgen-blocker developed by Astellas and Pfizer used as maintenance therapy for people with prostate cancer. Read More
More than half of the new drugs the FDA approved in 2022 were aimed at rare diseases, according to the Center for Drug Evaluation and Research’s (CDER) just-released New Drug Therapy Approvals report. Read More
A federal court has declared that HHS may determine how it will pay back the more than $1 billion it owes hospitals for years of underpayments related to the 340B drug discount program. Read More