11 minutes | Jun 21st 2018

153 - ACX-362E for CDI; Cosentyx and inhibition of joint damage progression; new assays from Grifols; personalized optimization of insulin pump therapy; FDA and drug shortages for critical products; FDA guidance on attacks on food supply

June 21, 2018 Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com  0:47 FDA Grants QIDP Designation to Acurx's Lead Antibiotic Product Candidate, ACX-362E for Clostridium Difficile Infection https://www.prnewswire.com/news-releases/fda-grants-qidp-designation-to-acurxs-lead-antibiotic-product-candidate-acx-362e-for-clostridium-difficile-infection-300669455.html 2:14 Novartis receives FDA approval for inclusion of new evidence that Cosentyx® inhibits progression of joint structural damage in psoriatic arthritis https://www.prnewswire.com/news-releases/novartis-receives-fda-approval-for-inclusion-of-new-evidence-that-cosentyx-inhibits-progression-of-joint-structural-damage-in-psoriatic-arthritis-300668938.html 3:22 Grifols Expands its NAT Solutions Portfolio with New FDA Approvals for Two Assays https://www.prnewswire.com/news-releases/grifols-expands-its-nat-solutions-portfolio-with-new-fda-approvals-for-two-assays-300668493.html 4:30 DreaMed Diabetes Granted FDA Authorization to Market Advisor Pro, Offering Personalized Optimization of Insulin Pump Therapy https://www.prnewswire.com/news-releases/dreamed-diabetes-granted-fda-authorization-to-market-advisor-pro-offering-personalized-optimization-of-insulin-pump-therapy-300667617.html 5:56 FDA responds to ongoing drug shortages for critical products https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611215.htm https://www.fiercepharma.com/manufacturing/fda-says-drug-shortages-again-rise-after-5-years-improvements 8:03 New FDA guidance to help manufacturers implement protections against potential attacks on the U.S. food supply https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611177.htm http://www.cidrap.umn.edu/news-perspective/2018/06/fda-releases-new-guidance-food-defense Please check out my weekly podcast AI in Medicine. Podcast website is aimedicinenews.com  
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