The companion diagnostic (CDx) has been a mainstay of oncology care for several years, but Richard Pazdur, director of the U.S. FDA’s Oncology Center of Excellence (OCE), said recently in a public forum recently that the notion of a single CDx for an investigational drug has not served patients well. Pazdur said OCE and the FDA’s Center for Devices and Radiological Health are working on a pilot program that would entail the publication of performance standards for the tests used in these trials, a development that would lead to more routine development of lab-developed tests (LDTs) for these studies and thus undercut any incentive to develop a patented in vitro diagnostic for that purpose.
Global interest in radiopharmaceuticals is growing, and some big deals in the space have sparked interest in the last few years. Novartis AG has spent about $6 billion in acquisitions and is seen as the global leader.
Global interest in radiopharmaceuticals is growing, and some big deals in the space have sparked interest in the last few years. Novartis AG has spent about $6 billion in acquisitions and is seen as the global leader.
Radiopharmaceutical company Telix Pharmaceuticals Ltd’s TLX250-CDx (Zirconium (89Zr) TX250) met both primary and secondary endpoints in the phase III Zircon study in clear cell renal cell carcinoma, according to top-line data.
Radiopharmaceutical company Telix Pharmaceuticals Ltd’s TLX250-CDx (Zirconium (89Zr) TX250) met both primary and secondary endpoints in the phase III Zircon study in clear cell renal cell carcinoma, according to top-line data.
While weekly global and U.S. confirmed cases of COVID-19 are below each of the last two years, infectious disease experts remain on guard. There are still about 1,500 people dying around the world each day, including 350 in the U.S., and the SARS-CoV-2 virus may continue to find ways to outmaneuver current treatments and vaccines.
Thermo Fisher Scientific Inc. has agreed to acquire The Binding Site Group (BSG) from a shareholder consortium in a $2.6 billion cash transaction that folds in neatly with Thermo Fisher’s existing product portfolio. The acquisition should be completed in the first half of 2023, but while the news had only a modest effect on Thermo’s share prices, this transaction should boost adjusted earnings per share by seven cents in the first full year after the transaction has closed.
Nowadays, there are many tools for cancer diagnosis, from imaging techniques to biopsies. In traditional blood tests, liquid biopsy bursts onto the scene as an explosion of possibilities driven by molecular techniques for the detection and sequencing of proteins or genetic material. But specialists are cautious because they know that in liquid biopsies not everything is detected. At the ENA 2022 session “The role of ctDNA in clinical trials,” Marie Morfouace, a translational researcher at the EORTC, presented “ctDNA in clinical trial practice today,” where she described the balance of the possibilities of the liquid biopsy when confronting it with the results in patients offered by the studies published to date.
Researchers from the University of Saskatchewan have developed a novel theranostic candidate, [67Cu]EB-TATE, as an alternative to [177Lu]DOTATATE, for the imaging of gastroenteropancreatic neuroendocrine tumors (GEP-NET). EB-TATE, which is a derivative of octreotate with evans blue (EB), was radiolabeled with electron linear accelerator-produced 67CuCl2.
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