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The Department of Justice (DOJ) has resolved criminal antitrust charges against Teva Pharmaceuticals and Glenmark Pharmaceuticals for price fixing with deferred prosecution agreements, hefty fines, admission that the DOJ’s facts are true and a requirement to divest key lines of business. Read More
Ten years and $2.5 billion — that’s what it takes, on average, to bring a new drug to market in the United States. Artificial intelligence (AI) promises to supercharge this process, drastically reducing the time and costs of bringing life-saving therapies to market. Read More
The FDA has issued multiple draft and revised product-specific guidances that provide recommendations on the design of bioequivalence studies to support ANDAs and facilitate generic drug product availability. Read More
After suffering the setback of a complete response letter (CRL) concerning its contract manufacturing plant, Regeneron has bounced back with FDA approval of two drugs — Eylea HD (aflibercept 8 mg) and Veopoz (pozelimab-bbfg). Read More
Krystal Biotech is offloading its priority review voucher (PRV) for a cool $100 million to an undisclosed buyer, a practice that nets companies cash — in highly variable amounts. Read More
The FDA’s Circulatory System Devices Panel will review premarket applications for two investigational renal denervation devices this week, both designed to help control refractory hypertension by ablating some of the sympathetic nerves that wrap around the renal artery. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
A federal appeals court has rejected four provisions of an Oklahoma law regulating prescription benefit managers (PBM), arguing the provisions were preempted by existing federal law. Read More
The FDA cites inadequate product labeling as the reason for marking Abiomed’s June recall of its Impella RP Flex with Smart Assist system catheter as class I, the most serious type of recall as use of the device may cause injury or death. Read More
After numerous setbacks, Ipsen has won FDA approval for Sohonos (palovarotene), the first treatment for fibrodysplasia ossificans progressiva (FOP), a disease that causes connective tissue — muscle, tendons and ligaments — to gradually turn to bone. Read More
Florida has continued its pursuit of a program to import prescription drugs from Canada, this week filing an amended complaint about the FDA’s delay in responding to its July 2022 Freedom of Information Act (FOIA) request for documents on reasons the FDA hasn’t yet made a decision. Read More
Over the past week, the FDA issued final guidance on informed consent and premarket notification for magnetic resonance devices and extended the comment period for a draft guidance on demonstrating bioequivalence for type A medicated articles containing certain active pharmaceutical ingredient(s). Read More