In December 2020, Servier Pharmaceuticals LLC bought Agios Pharmaceuticals Inc.’s approved acute myeloid leukemia drug, Tibsovo (ivosidenib), and the rest of its oncology business in a deal valued at up to $2 billion. Now, the U.S. FDA has approved one of those assets, with the brand name Voranigo (vorasidenib), for treating gliomas.
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.
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.
In June 2024, BioWorld covered 221 clinical trial updates, compared to 298 in May. BioWorld recorded 23 phase III trial successes in June, seven failures, and one with mixed results.
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.
The U.S. FDA has approved Sun Pharmaceutical Industries Ltd.’s Leqselvi (deuruxolitinib), a JAK1 and JAK2 inhibitor for adults with severe alopecia areata, a chronic autoimmune disease. The twice-daily, oral treatment will be targeting a company-estimated market of about 300,000 people in the U.S. This is the third FDA-approved treatment for severe alopecia areata in the past three years.
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