Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
LONDON – Orthox Ltd. is primed for an assault on the mountain that is knee cartilage repair after raising $12.5 million in a series A funding round. After more than a decade of translational and preclinical research, these funds will allow the company to start a trial of Fibrofix, a tissue regeneration product derived from silk, in the middle of this year. An initial cohort of six patients in the U.K. will be treated for sports injury-related cartilage damage, with six months follow up to demonstrate safety. Assuming positive results, that will be followed by treating a further 75 patients in the U.K., Hungary and elsewhere in mainland Europe.
Lyme disease is the most common vector-borne disease in the U.S. and is also common in certain areas of Europe. Yet, despite this, there are no FDA-approved vaccines available to treat it, meaning those diagnosed must receive a dose of antibiotics. But antibiotics are problematic because of the risk of treatment-resistant strains emerging. That leaves a pressing need for a vaccine or other way to prevent infections from the tick-borne bacterium Borrelia burgdorferi.
More than 100 million people worldwide are thought to have post-acute COVID-19 syndrome, roughly 40% of everyone on the planet who’s had COVID. Now, thousands of them are beginning to cycle through clinical and preclinical studies designed to get a better look at this little understood aspect of the pandemic.
Know Labs Inc. has received approval from an independent institutional review board for an internal clinical study of its noninvasive glucose monitoring technology. The aim is to further validate the Bio-RFID (radio frequency identification) platform’s ability to accurately measure and detect changes in blood glucose levels. The study will be conducted at the Seattle-based company’s new research and development laboratory and include 200 subjects.
Wall Street nicked shares of Karyopharm Therapeutics Inc. after the firm offered top-line results from the 263-subject phase III study with Xpovio (selinexor) in advanced or recurrent endometrial cancer (EC). Shares (NASDAQ:KPTI) closed at $8.19, down $2.05, or 20%, having dropped as low as $7.66.
Scientists from Healthbiocare GmbH, System Biologie AG and the University of Austria have published data indicating pan-cancer detection could be achieved by combining genetic and epigenetic biomarkers in plasma. The scientists developed a classification model that distinguished between healthy subjects and patients with solid tumors with 95.4% accuracy, 97.9% sensitivity, and 80% specificity.
LONDON – Three patients with complete spinal cord injury are able to walk independently after having specialized electrodes implanted below their lesions. The details were published in Nature Medicine on Feb. 7. This is a significant new milestone for the researchers at École polytechnique fédérale de Lausanne (EPFL), Switzerland, who in 2018 delivered proof that electrical stimulation can reactivate spinal neurons, in that case in three patients with partial spinal cord injury. “Here for the first time, we have developed purpose-made technology in order to precisely stimulate the spinal cord to restore movement after paralysis,” said Gregoire Courtine, professor of spinal cord repair at EPFL.
The pivotal, multicenter trial commissioned by Envveno Medical Corp. is intended to show its first-in-class Venovalve implant is safe and effective for treating deep venous chronic venous insufficiency (CVI), which occurs when damaged valves inside the veins of the leg prevent blood from flowing up the leg and into the heart and lungs.
San Francisco-based startup Mirvie Inc. has released data demonstrating how its RNA platform technology can predict preterm birth. The research, presented at the Society for Maternal-Fetal Medicine 42nd Annual Pregnancy Meeting (SMFM 2022), showed the company’s test predicted the condition months before symptoms occurred and identified biological pathways that drive changes in pregnancy.
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