GE Healthcare Technologies Inc. received U.S. FDA approval for its novel radiotracer, Flyrcado (flurpiridaz F-18), for use in the diagnosis of myocardial ischemia or infarction in patients with known or suspected coronary artery disease.
Seoul, South Korea-based Adel Inc. raised ₩17 billion (US$12.39 million) in bridge financing to advance its pipeline of Alzheimer’s disease therapies, including its tau antibody-based ADEL-Y01 candidate, currently in a U.S.-based phase I study.
The U.S. Medicare outpatient draft for 2025 is rich with applications for pass-through payment, but the draft also would boost payment for radiopharmaceuticals, a proposal that drew the applause of industry and physicians alike. The outpatient draft for CY 2025 tackles the implications of some new technologies for the pass-through payment program, but nestled in the draft rule is a proposal to pay separately for diagnostic radiopharmaceuticals.
Astrazeneca plc’s blockbuster Enhertu continued to garner attention as new data released at the American Society of Clinical Oncology (ASCO) annual meeting show the antibody-drug conjugate demonstrated strong progression-free survival in metastatic breast cancer patients. Puma Biotechnology Inc. had advances of its own at ASCO with new biomarker findings from a phase II study of alisertib, an aurora protein kinase 2 inhibitor, in endocrine-resistant metastatic breast cancer.
At a recent meeting on “Research priorities for preventing and treating Alzheimer’s disease and related dementias” (ADRD), convened by the National Academies, one consensus priority on ADRD research was that there needs to be more of it at every stage. Several speakers presented stark numbers on the relative volume of research in cancer and neurodegeneration. Research output, measured in peer-reviewed papers, for dementia is estimated to be around 10,000 papers annually, compared to 150,000 for cancer, while AD clinical trials are also few and far between compared to cancer trials. This final installment of BioWorld’s series on Alzheimer’s explores some of the reasons for this discrepancy along with the latest advances and ongoing efforts to accelerate research and drug development in the field.
While members of the U.S. FDA’s Imaging Drugs Advisory Committee weren’t blown away March 5 by the trial performance of Lumicell Inc.’s Lumisight (pegulicianine) in helping breast cancer patients avoid second surgeries due to negative margins following a lumpectomy, they voted 16-2, with one abstention, that the benefits of the imaging drug outweigh its risks, even though those benefits are incremental.
The March 5 meeting of the U.S. FDA’s Medical Imaging Drugs Advisory Committee could be the gateway to the first approved intraoperative technology for use in breast cancer that directly examines the lumpectomy cavity for residual cancer.
Unless there’s a last-minute meeting of the minds, it looks like any extension of the World Trade Organization’s (WTO) five-year intellectual property waiver for COVID-19 vaccines will be shelved, at least for now.
The U.S. Department of Health and Human Services (HHS) has released a sweeping plan that is designed to help manage vector-borne pathogens, such as the Zika virus, with the ultimate goal of reducing the related disease burden to zero.
Researchers at ETH Zurich have identified a proteomic signature that could recognize long COVID six months after acute infection. Biologically, the signature indicated that the complement system remained active in patients with long COVID six months after infection. Translationally, it could lead to a diagnostic test for long COVID, and suggests that targeting the complement system could be a therapeutic approach to prevent or treat the disorder.
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