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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
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
The U.S. Court of Appeals for the First Circuit said that it will not revive several hundred lawsuits accusing GSK of failing to warn female patients that its anti-nausea therapy Zofran (ondansetron) could induce birth defects. Read More
Otsuka and developmental partner Lundbeck have snagged FDA priority review of their supplemental new drug application (sNDA) for Rexulti (brexpiprazole) as a treatment for agitation in people with Alzheimer’s disease. Read More
In a move that could affect many drugmakers and their patient assistance programs, the U.S. Supreme Court has refused to take up Pfizer’s appeal that it should be able to offer a copay assistance plan to patients to help them pay for the company’s expensive heart medication. Read More
The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee struggled to find definitive answers when it met Monday to consider dosing and labeling for Regeneron Pharmaceuticals’ aflibercept as a treatment for retinopathy of prematurity (ROP), a leading cause of childhood blindness. Read More