This week on Pharm5:
- Oral tebipenem noninferior to IV ertapenem for complicated UTIs
- Stelara’s potential biosimilar ustekinumab ABP 654’s promising results
- SODIUM-HF trial finds no benefit to extreme sodium restriction in heart failure
- InspectIR COVID-19 Breathalyzer receives EUA
- Avastin’s third biosimilar bevacizumab-maly (Almsys) approved
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References:
- Eckburg PB, Muir L, Critchley IA, et al. Oral tebipenem pivoxil hydrobromide in complicated urinary tract infection. New England Journal of Medicine. 2022;386(14):1327-1338. doi:10.1056/nejmoa2105462.
- Amgen announces positive top-line results from phase 3 study of ABP 654, Biosimilar candidate to STELARA® (ustekinumab). Amgen. https://www.amgen.com/newsroom/press-releases/2022/04/amgen-announces-positive-topline-results-from-phase-3-study-of-abp-654-biosimilar-candidate-to-stelara-ustekinumab. Published April 18, 2022. Accessed April 20, 2022.
- Jeremias S. Amgen releases Positive Phase 3 results for Stelara Biosimilar. The Center For Biosimilars. https://www.centerforbiosimilars.com/view/amgen-releases-positive-phase-3-results-for-stelara-biosimilar. Published April 19, 2022. Accessed April 20, 2022.
- Ezekowitz JA, Colin-Ramirez E, Ross H, et al. Reduction of dietary sodium to less than 100 mmol in heart failure (Sodium-Hf): An international, open-label, randomised, controlled trial. The Lancet. 2022;399(10333):1391-1400. doi:10.1016/s0140-6736(22)00369-5.
- Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure. Journal of the American College of Cardiology. April 2022. doi:10.1016/j.jacc.2021.12.012
- Commissioner of the Coronavirus (COVID-19) update: FDA authorizes first COVID-19 diagnostic test using breath samples. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-diagnostic-test-using-breath-samples. Published April 14, 2022. Accessed April 20, 2022.
- Pharmacypracticenews.com. https://www.pharmacypracticenews.com/FDA-Approvals/Article/05-22/Third-Biosimilar-to-Bevacizumab-Approved/66766. Published April 19, 2022. Accessed April 21, 2022.
