With time running out on the 118th U.S. Congress, a group of lawmakers is urging the leadership of the House Energy and Commerce Committee to consider a bipartisan path forward on strengthening the 340B drug discount program.
China will deepen its health care reforms and will focus on enhancing its public health care capacity at the primary care level and at public hospitals, according to resolutions passed at the third plenary session of the 20th Central Committee of the Communist Party of China in July.
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.
The possibility of a 2025 approval looks to be off the table for Actinium Pharmaceuticals Inc.’s Iomab-B, at least in the U.S. In a move that H.C. Wainwright analyst Joseph Pantginis dubbed “a major surprise,” the FDA has requested a head-to-head study demonstrating overall survival before it will consider approving the radiotherapy candidate for use in patients with active relapsed or refractory acute myeloid leukemia.
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.
As the Sept. 21 PDUFA date looms for arimoclomol from Zevra Therapeutics Inc. in Niemann-Pick type C (NPC), the U.S. FDA’s newly formed Genetic Metabolic Diseases Advisory Committee (GeMDAC) decided in favor of the drug.
A T-cell therapy from Adaptimmune Therapeutics plc has received accelerated approval from the U.S. FDA to treat advanced synovial sarcoma (SS). Tecelra (afamitresgene autoleucel), a CAR T targeting MAGE-A4, is the first engineered T-cell therapy for solid tumors and the first treatment option for the indication in more than a decade.
The proposal to overhaul the use of terminal disclaimers in U.S. patent filings won over no fans among former directors of the U.S. Patent and Trademark Office, but device and drug makers, too, are concerned about the proposal.
Radiopharmaceutical company Telix Pharmaceuticals Ltd. received a U.S. FDA refusal to file letter for its BLA seeking approval of renal cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) for clear cell renal cell carcinoma (ccRCC).
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.
RSS
