Paragonix Technologies Inc. will soon release performance data from sterile, temperature-controlled systems for transporting donor organs to recipient patients, this after a breath-taking transport last year of a donor lung and heart from Alaska to Washington and North Carolina. Paragonix’s organ preservation technology provides thermal protection for donor organs for up to 40 hours, making them ideal for transportation over long distances, said the company.
Abbott Laboratories reported the commencement of a pivotal clinical trial for its Aveir pacemaker in a two-device configuration to provide dual-chamber pacing without the need for leads to deliver the charge. This configuration required the development of i2i technology to ensure that the two Aveirs communicated in a manner that ensures consistent pacing, but the 500-enrollee study has a long road ahead of it before the company can finalize the application with the FDA.
Delivering important but likely unwelcome news to Americans increasingly trying put the COVID-19 pandemic behind them, new research published Feb. 11 by the CDC suggested that "protection conferred by mRNA vaccines waned in the months after receipt of a third vaccine dose reinforces the importance of further consideration of additional doses to sustain or improve protection against COVID-19-associated [emergency department or urgent care (ED/UC)] encounters and COVID-19 hospitalizations."
Proqr Therapeutics NV stock lost three-quarters of its value as word got out that its pivotal phase II/III study of sepofarsen in treating a tough, rare and genetic retinal disease failed to hit the primary endpoint. CEO Daniel de Boer said he was “shocked by the unexpected outcome” based on data from earlier studies. He added that he is unsure if Proqr will continue developing its therapy for treating CEP290-mediated Leber congenital amaurosis 10 until it understands the new results.
Cincor Pharma Inc.’s IPO at the start of the year underlined hopes for a new way to attack treatment-resistant hypertension and related diseases, as the Boston-based firm touted what one analyst called it ‘pipeline in a pill,” CIN-107, which selectively targets aldosterone synthase to lower aldosterone levels, in turn knocking down blood pressure.
Redhill Biopharma Inc. continues pushing ahead with efforts to add to the limited arsenal of therapies for treating hospitalized severe COVID-19 infections, with the latest data, based on prespecified analyses from a phase II/III study showing its SK2 inhibitor, opaganib, significantly reduced mortality when given on top of standard-of-care (SOC) Veklury (remdesivir, Gilead Sciences Inc.) and corticosteroids. The Tel Aviv, Israel-based company said potential emergency use and marketing applications are planned in the first half of this year.
A bioelectronic device developed by U.K. startup Ceryx Medical Ltd. has shown potential to restore cardiac performance in preclinical studies. The Cardiff, Wales-based company published data showing its Cysoni technology increased cardiac output by 20% compared to current pacemakers.
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.
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