Modra Pharmaceuticals BV is planning to move its oral formulation of docetaxel into a pivotal trial, hoping to offer advanced prostate cancer patients a safer treatment option than intravenous chemotherapy. The Amsterdam, the Netherlands-based company has just announced phase IIb results in metastatic castration-resistant prostate cancer from ModraDoc-006/r, a tablet containing docetaxel and co-administered with ritonavir to enhance bioavailability.
A phase III study of Sage Therapeutics Inc.’s zuranolone in major depressive disorder hit not only its primary endpoint but also its key secondary endpoint. Despite that, the Cambridge, Mass.-based company’s share value (NASDAQ:SAGE) closed 17.4% lower Feb. 16, at $35.91 each.
As investors await the Sept. 10 PDUFA date for deucravacitinib from Bristol Myers Squibb Co. (BMS) in psoriasis, handicappers continue to weigh the odds of other tyrosine kinase 2 (TYK2) inhibitors, and ponder what a regulatory victory – or defeat – might mean for the space.
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.
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.
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.
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