Fresh data from Johnson & Johnson show COVID-19 protection dramatically increased with a booster shot of its single-dose vaccine, adding momentum to the U.S. drive for boosters.
Prophet, Oncohost Ltd.’s artificial intelligence-driven proteomics profiling platform, predicted response to immune checkpoint inhibitor (ICI) therapy in non-small-cell lung carcinoma (NSCLC) patients in a study presented at the European Society for Medical Oncology Virtual Congress 2021. While ICI can generate a significant positive response in some patients with advanced NSCLC, in others the therapy promotes tumor growth, making identification of likely responders prior to treatment critical.
Sanofi SA’s high-profile phase III blow-up Sept. 9 with the oral BTK inhibitor rilzabrutinib in pemphigus brought fresh attention to the group of rare diseases – which cause blisters on the skin and mucous membranes throughout the body – and to players pushing for a new treatment.
Despite Beyondspring Pharmaceuticals Inc.’s phase III study meeting its primary and key secondary endpoints of a plinabulin/docetaxel combination in treating non-small-cell lung cancer (NSCLC), the company stock (NADAQ:BYSI) took a pounding. Shares sunk 32.9% on Sept. 20 to close at $15.36 each.
Pfizer Inc. and Biontech SE have announced new data that could pave the way for childhood COVID-19 vaccine programs, with findings of a trial showing their shot is safe and effective in children of 5 to 12 years of age.
Shares of Protagonist Therapeutics Inc. (NASDAQ:PTGX) fell 62% to $17.53 on Sept. 17 after it reported finding malignant skin tumors in a mouse model test of its most advanced candidate, rusfertide for blood disorders. After the company notified the FDA, the regulator put the program on a clinical hold, leading dosing of patients in all ongoing trials of rusfertide to be halted for now. The development could impact Protagonist's ability to start phase III testing of the candidate in polycythemia vera (PV) early in 2022, as well as efforts to expand its development to a third indication beyond PV and hereditary hemochromatosis (HH) by the end of this year, as it has planned.
Nearly 18% of clinical data reported in August were focused on the COVID-19 pandemic, representing the highest percentage for any single month this year. During the month, as the Delta variant took hold throughout the U.S., news of COVID-19 efforts spiked, doubling the amounts seen in both June and July, in which about 9% of the news was pandemic-related, and up significantly from 10% in May.
A multicenter study has found that a multiplex diagnostic panel developed by Opgen Inc. can reduce the use of inappropriate antibiotic therapy by 45.1%. Opgen’s Unyvero Hospitalized Pneumonia (HPN) panel uses PCR technology that can detect 21 pathogens and 17 antibiotic resistance markers in less than five hours. During the European Respiratory Society conference, Rockville, Md.-based Opgen presented data showing that combined with antibiotic stewardship, its HPN panel decreased time on inappropriate antibiotic therapy in hospitalized patients with pneumonia at risk for Gram-negative rods.
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