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A federal judge in Massachusetts ruled that seven former Insys Therapeutics executives must pay nearly $57 million in restitution for their role in the company’s scheme to boost prescriptions of its sublingual fentanyl spray Subsys. Read More
Sen. Chuck Grassley (R-Iowa) said he expects his drug pricing bill S. 2543 to pass in the Senate by May 20, just two days before the deadline to renew expiring healthcare programs. Read More
The FDA and the government of India stopped hundreds of shipments of illicit prescription drugs and combination products from entering the U.S. during their first joint enforcement operation, the two regulators announced yesterday. Read More
FDA Commissioner Stephen Hahn said the agency is taking a “forward-leaning approach” to identify supply chain shortages caused by the coronavirus outbreak and isn’t waiting around for drugmakers to report them. Read More
Nearly 600 pediatric drugs across various therapeutic areas are currently being tested in clinical trials, according to a report from the Pharmaceutical Research and Manufacturers of America (PhRMA). Read More
A federal appeals court in Ohio stayed an order requiring pharmacies to submit 14 years of nationwide opioid dispensing data in the state’s ongoing multi-district opioid litigation, limiting the scope to just the state of Ohio. Read More
CBER unveiled its guidance agenda for the 2020, including planned draft guidances on gene therapy for neurodegenerative diseases, CAR-T cell therapies and genome editing. Read More