The U.S. Department of Health and Human Services (HHS) is 6-1 so far in blocking court challenges to the Medicare price negotiation program mandated by the Inflation Reduction Act (IRA). The department’s latest victory came July 31 when a federal district judge in New Jersey tossed a complaint filed by Novo Nordisk A/S, citing a lack of jurisdiction on the court’s part and the company’s lack of standing.
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.
Zevra Therapeutics Inc. will make its case Aug. 2 for its Niemann-Pick type C (NPC) candidate, arimoclomol, when the U.S. FDA’s Genetic Metabolic Diseases Advisory Committee (GeMDAC) meets for the first time.
For the first time in six years, the U.K.’s National Institute for Health and Care Excellence (NICE) is refusing to recommend a breast cancer treatment. It cited price as the issue.
With the COVID-19 pandemic still visible in the rearview mirror, the World Health Organization (WHO) is taking no chances as it preps for human avian influenza, or H5N1, a subtype of influenza A.
As the U.S. FDA and the Advanced Research Projects Agency for Health (ARPA-H) move forward with new guidance and foundational data, they both recently issued requests for information (RFIs) to help them advance their agendas.
Even as U.S. lawmakers continue to push back against the rising price of prescription drugs and patients with life-threatening diseases clamor for access to new treatments, the FDA is considering a step that could increase the cost and lengthen the development time of therapies targeting non-small-cell lung cancer and perhaps other solid tumors.
The July 25 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) could impact the future development of immune checkpoint inhibitors, such as Astrazeneca plc’s Imfinzi, to treat patients with non-small-cell lung cancer (NSCLC) both before and after surgery. Although much of the discussion will focus on an sBLA for Imfinzi (durvalumab), the committee will be asked to vote on whether the FDA should require that new trial design proposals for perioperative regimens for resectable NSCLC include adequate within-trial assessment of the contribution of the treatment phase to efficacy results.
Noting that the median list price of new drugs that entered the U.S. market last year hit $300,000, senior officials of the three biggest pharmacy benefit managers (PBMs) in the country once again denied responsibility for those prices as they testified before the House Oversight Committee July 23 in the third hearing the committee has held on PBM practices.
As the U.S. Congress continues to pass laws that require federal agencies to issue rules to implement new statutory provisions, a group of lawmakers is reminding the agencies that it will be looking over their shoulders to ensure they don’t stray beyond the scope of the law or overstep their authority.
