A feasibility study conducted by the University of Queensland (UQ) confirmed the utility of Inoviq Ltd.’s exosome-based ovarian cancer screening test for isolating extracellular vesicle (EV) biomarkers. The Ovarian Cancer 97 study (OC97) screened data from 97 plasma samples and identified significant differences between the EV biomarker content of ovarian cancer and healthy control samples.
Even though Cytokinetics Inc. received applause for testing its heart failure drug, omecamtiv mecarbil, in the second largest global heart disease clinical trial ever, the drug didn’t get a standing ovation from the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Dec. 13.
Olive Diagnostics Pvt. Ltd. is looking to raise $10 million in a series A funding round to extend sales and marketing activities, after getting CE approval for its urine analysis device that mounts on any toilet. Among other parameters the device, Olive KG, can measure red blood cells, proteins, nitrates, pH levels volume, pressure and frequency of urination.
What could be Cytokinetics Inc.’s first approved drug will take center stage Dec. 13 at a meeting of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee. But judging from the FDA’s briefing document for the meeting, the spotlight on the heart failure drug, omecamtiv mecarbil, could be harsh.
Enzyre BV reported closing a $12.5 million series A round to ramp development of its micro diagnostics platform used for monitoring blood coagulation status at home.
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.
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