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A July 10-20 FDA inspection of a Biocon manufacturing facility in Malaysia turned up eight observations including a repeat observation of failure to follow procedures that prevent microbiological contamination of drugs intended to be sterile, and inadequate review and investigation of failed batches. 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 a webinar from FDAnews, a WCG company on medical device risk management tools. Read More
Amgen and Horizon have launched a return volley in their battle with the FTC, asking the U.S. District Court of Northern Illinois to deny the FTC’s July motion that sought to strike down arguments that Amgen and Horizon’s constitutional defenses are legitimate considerations in the case. Read More
In a recent court filing, HHS lambasted the U.S. Chamber of Commerce’s recent call to slow down implementation of pricing negotiations within the Inflation Reduction Act (IRA), calling the group’s efforts “hyperbolic” and accusing it of just trying to lobby Congress in court to stop the Act’s efforts to drive down the cost of prescription drugs. Read More
This first European Edition of Quick Notes includes a PDUFA date extension for a chikungunya vaccine candidate, NICE approved AI technologies for radiotherapy treatment therapies, Novartis cited for claims made on an Entresto podcast and comments on the EU proposal for compulsory licensing. Read More
Oncopeptides is appealing a formal request from the FDA to withdraw its blood cancer therapy drug Pepaxto (melphalan flufenamide) as the agency flexes its newfound regulatory authority for pulling drugs that receive an accelerated approval but fail confirmatory studies. Read More
PhRMA, the National Infusion Center Association and the Global Colon Cancer Association have filed a motion for summary judgment — a final decision made by a judge without going to trial — in their case against HHS over the Inflation Reduction Act’s (IRA) drug price negotiation program. Read More
More than 60 percent of the drugs approved last year won their FDA nod on the basis of a single clinical trial that was conducted by the drug sponsor, a new analysis has determined. 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
In July, the court said that PTAB used incorrect legal framing and conducted an erroneous obviousness analysis in its opinion on separate but related Medtronic patents. Read More