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Spectrum Pharmaceuticals failed to impress an FDA advisory committee, which unanimously voted against recommending approval of the company’s treatment to prevent recurrence of low-grade non-muscle invasive bladder cancer. Read More
The National Institute for Occupational Safety and Health is holding a public meaning on a testing protocol for universal closed system drug-transfer devices (CSTDs). Read More
A year from now, each drug product processed and moved through the U.S. supply chain could have its own unique identifier under the Drug Supply Security Act, FDA and industry officials said at a meeting Monday. Read More
The Regulatory Affairs Professionals Society has named longtime member Paul Brooks as its new executive director, effective Sept. 12. Brooks, an expert on medical device regulation, joins RAPS after a 35-year career at the British Standards Institution. Read More
Eisai presented data from two Phase III studies of adjunctive therapies for epilepsy—one evaluating the non-inferiority of Zebinix compared to carbamazepine, and an open-label extension study of long-term Fycompa, which demonstrated sustained seizure control for up to two-and-a-half years. The two studies were presented at the European Congress on Epileptology. Read More
Novo Nordisk presented two separate Phase III studies in type 2 diabetes—evaluating semaglutide and Xultophy—at the annual meeting of the European Association for the Study of Diabetes. Read More