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.
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.
The U.K. is launching a £230 million (US$260 million) project to build a database linking the health records and genetic information of 5 million people, which will be open for discovery research and as a source of clinical trial recruits for academics and companies.
Enhanc3D Genomics Ltd. has raised £10 million (US$11.3 million) in a series A round to advance development of its Genlink3D technology for directly linking gene regulators in non-coding DNA to their target protein coding genes.
Synaptive Medical Inc. has introduced a free water correction feature to its Modus Plan software to restore tracts in areas surrounding brain lesions affected by edema and which interferes with automated mapping of the brain. Water from edema obscures retrieval of diffusion tensor imaging (DTI) data and tractography mapping used to evaluate white matter pathways in the brain.
Radiopharm Theranostics Ltd.’s phase II F-18 Pivalate positron emission tomography trial in brain metastases saw positive results with high uptake regardless of the origin of primary tumors, showing that Pivalate could be used to monitor brain metastases.
Spectral MD Holdings Ltd. has delivered stark evidence of the need for its Deepview wound imaging system, in a study showing that medics in emergency rooms making initial judgments on the severity of burns were accurate only in 74% of cases. The critical feature is the depth of a burn.
RSS
