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.

Salubris Biotherapeutics Inc. has received clearance by the European Medicines Agency (EMA) to begin a first-in-human basket trial of JK-06.

The U.K. National Institute for Health and Care Excellence endorsed the use of testing for the CYP2C19 genotype for management of clopidogrel usage after ischemic stroke and heart attack, but the agency is specific about the use of tests by Genedrive plc and Genomadix Inc. in point-of-care settings as alternatives to lab testing.

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.

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.

Innorna Co. Ltd.’s IN-016 has received orphan drug status from the U.S. FDA for the treatment of progressive familial intrahepatic cholestasis (PFIC). Earlier in July, IN-016 had been granted Rare Pediatric Disease Designation. PFIC is a group of rare genetic disorders associated with defects in bile acid secretion or transport, resulting in unwanted bile accumulation within the liver.

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.

U.S. federal preemption of state law for devices approved by the FDA is a matter of record, but a recent case affirms the staying power of Supreme Court jurisprudence on that point.

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).