15 minutes | Jul 19th 2018

160 - darunavir single tablet; pain relief study; Tau modifier gets orphan drug designation; IND for CARMA platform; CAM2038 for opioid use disorder; FDA's speedy oncology review pilot; empowering nonprescription drugs

July 19, 2018  Please subscribe, rate and review if you like this podcast. Thank you! The podcast website is http://newfdaapprovals.com 0:45 Janssen Announces U.S. FDA Approval of SYMTUZA™ (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection https://www.prnewswire.com/news-releases/janssen-announces-us-fda-approval-of-symtuza-dcftaf-the-first-and-only-complete-darunavir-based-single-tablet-regimen-for-the-treatment-of-hiv-1-infection-300682550.html  3:00 PainReform Gets FDA Approval for Phase III Post-Operative Pain Relief Study https://www.prnewswire.com/news-releases/painreform-gets-fda-approval-for-phase-iii-post-operative-pain-relief-study-300682836.html 4:08 Asceneuron's Tau Modifier ASN120290 Receives Orphan Drug Designation for Progressive Supranuclear Palsy From the FDA https://www.prnewswire.com/news-releases/asceneuron-s-tau-modifier-asn120290-receives-orphan-drug-designation-for-progressive-supranuclear-palsy-from-the-fda-859244062.html 6:20 MaxCyte Receives US FDA Investigational New Drug Clearance for First Clinical Program https://www.prnewswire.com/news-releases/maxcyte-receives-us-fda-investigational-new-drug-clearance-for-first-clinical-program-300681147.html 8:17 Camurus Announces PDUFA Date for CAM2038 for the Treatment of Opioid use Disorder https://www.prnewswire.com/news-releases/camurus-announces-pdufa-date-for-cam2038-for-the-treatment-of-opioid-use-disorder-300681160.html 9:33 FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613801.htm 12:16 Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613692.htm Just to let you know, I have a couple of new courses on Udemy. If you type in “Emma Nichols”, you’ll pull up my courses. The latest ones are Cancer Biology 101, How to Read and Interpret a Scientific Paper, and Freelance Medical Writing as a Career Choice. To check those out, just go to Udemy.com (Udemy.com) and type in “Emma Nichols” to pull them up.   Music credit: freemusicarchive.org/music/MindsEye/Yellow_Taxi/
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