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Sarepta Therapeutics was “surprised” to receive a complete response letter from the FDA for its new drug application for Vydonos 53 (golodirsen) for treatment of Duchenne muscular dystrophy. Read More
Progressive groups organized a series of rallies across the country Tuesday as part of a “People Over Pharma Profits” day of action. The coalition — dubbed “Lower Drug Prices Now” — includes Public Citizen, Health Care for America Now, Families USA, and MoveOn. The group planned 51 “People Over Pharma Profits” events across 32 states. Read More
The FDA is planning a small pilot program to test how it handles nonclinical study data submitted electronically in SEND 3.1 format — a Clinical Data Interchange Standards Consortium (CDISC) standard the agency has moved towards to gather more study data. Read More
Novartis is facing fresh scrutiny after a Swiss newspaper revealed on Sunday that an unnamed executive at the drugmaker sold nearly $1 million in company stock just weeks before news broke of the data manipulation surrounding Zolgensma, its $2 million spinal muscular atrophy treatment. Read More
Syneos Health offered some suggestions for the FDA’s draft guidance for drugmakers on assessing the risks and benefits of opioids, urging the agency to highlight prior opioid exposure, guidance on tapering use and proper disposal. Read More