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Although unanimously endorsing the safety of Medtronic’s Symplicity Spyral Multi-electrode Renal Denervation system, members of the FDA’s Circulatory System Devices Panel were split on both the efficacy and risk/benefit balance of the ultrasound-powered device, intended to treat hypertension by ablating sympathetic nerves in the renal arteries. Read More
Apellis Pharmaceuticals’ safety probe into reports of retinal vasculitis linked to its eye drug-device combo Syfovre (pegcetacoplan) has discovered that the culprit is likely the company’s injection kits, not the therapy itself. Read More
In a brief filed Monday, Amgen and Horizon argue that the U.S. District Court of Northern Illinois shouldn’t let the Federal Trade Commission (FTC) block their union over concerns that a dangerous monopoly on two blockbuster drugs will result. Read More
Intarcia Therapeutics will continue its seven-year quest for FDA approval of its drug-device diabetes treatment with an alternative form of hearing — a public hearing before an advisory committee on Sept. 21to discuss CDER’s refusal to approve the product. Read More
Upcoming events in the coming weeks include seven FDA advisory committee meetings as well as the the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, and webinars from FDAnews, a WCG company on medical device risk management tools and calculating sample sizes for verification and validation activities. Read More
An FDA advisory panel has endorsed ReCor Medical’s novel ultrasound renal denervation system, agreeing unanimously that it’s safe for use in adults with uncontrolled or inadequately controlled hypertension, although the 12 voting members disagreed about how effective the ReCor Paradise system will be in the long run. Read More
Should the FDA get the 11 percent increase in funding that it’s gunning for from Congress, a large chunk will be spent improving internal data quality at the agency, said FDA Commissioner Robert Califf on Tuesday. Read More
The legal fight around the Inflation Reduction Act’s (IRA) drug price negotiation policy continues as the AARP and Public Citizen have submitted amicus briefs supporting the law and Boehringer Ingelheim filed a lawsuit, joining other drugmakers’ and the U.S. Chamber of Commerce’s challenges. Read More
Philips has issued an urgent field safety notice for certain of its imaging systems for a potentially faulty foot switch that may lead to unintended radiation. Read More
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