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.
The European Society for Medical Oncology Congress 2021 has begun with a mix of education and multidisciplinary sessions in addition to symposia. Silverback Therapeutics Inc. was a presenter and took a hit on the market Sept. 16 with its interim phase I/Ib study results showing SBT-6050’s proof of mechanism was established with activated myeloid and T/natural killer cells when treating advanced or metastatic HER2-expressing solid tumors.
Aerie Pharmaceuticals Inc.’s wide-net endpoint approach with the phase IIb study called Comet-1 seemed less than appreciated by the stock market as the firm unveiled top-line data in dry eye disease with AR-15512.
DUBLIN – Allarity Therapeutics A/S plans to file an NDA with FDA for dovitinib in renal cell carcinoma (RCC) in the fourth quarter this year, after unveiling a new analysis at the European Society for Molecular Oncology’s virtual congress, which suggest that its companion diagnostic, DRP, can identify patients who obtain a survival benefit from the therapy.
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