Coming as no surprise, the U.S. Senate’s Feb. 13 confirmation of Robert Kennedy as the next secretary of the Department of Health and Human Services (HHS) did nothing to ease the uncertainty hanging over the FDA and other HHS agencies.
The fast pace in which the Trump administration has rolled out changes to how government and businesses operate – a disruptive effort that appears to be creating a new world order – has caught the attention of biopharma industry leaders who spoke Tuesday at the Biotechnology Innovation Organization’s CEO and Investor Conference in New York.
With key officials yet to be confirmed at the U.S. Department of Health and Human Services, the acting secretary imposed an immediate pause throughout the department on publicly issuing any document or communication without first getting it approved by a presidential appointee.
Inflation continues to take a toll on U.S. FDA drug and device user fees with some of the fees increasing as much as 44% for fiscal 2025. While most fee increases for generics and innovative drugs and biologics are below 10%, the ANDA fee is jumping 28% to $321,920.
Nearly four years after the COVID-19 pandemic closed government offices and sent federal employees home to work remotely, the U.S. FDA is returning to some semblance of normalcy, with its drug and biologics centers expanding in-person face-to-face industry meetings to include all PDUFA and BsUFA meeting types, beginning Jan. 22.
Five years after Gilead Sciences Inc. gave up on momelotinib in the wake of two phase III failures in myelofibrosis, the JAK1/2 and ACVR1 inhibitor has found its way to the market in the hands of GSK plc. Branded Ojjaara, the drug gained U.S. FDA approval for use in intermediate- or high-risk myelofibrosis patients with anemia regardless of prior administration with JAK inhibitors such as Jakafi (ruxolitinib, Incyte Corp.).
HLB Co. Ltd. is ready to take half of the liver cancer treatment market with its potential first-line treatment, rivoceranib, currently undergoing U.S. FDA review, company chairman Jin Yang-gon said, backed by positive survival data that beat out competitors by three months.
Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies.
Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies. No additional efficacy or safety data has been requested.
Phathom Pharmaceuticals Inc.’s shares sank 31% on news that the U.S. FDA will not take action on the company’s NDA for oral small-molecule potassium-competitive acid blocker vonoprazan by the Jan. 11 PDUFA date.
