Host: Sara W. Koblitz 


  Guest: Michael J. Thorpy, MD 



  
    Since the release of this activity, the FDA has approved the use of Once-Nightly Sodium Oxybate. Visit the FDA statement dated May 1, 2023.https://firstwordpharma.com/story/5734060 While most clinicians are aware of a drug being either “approved” or “not approved” by the FDA, many are not familiar with the term “tentative approval.” Leading experts, attorney Sara Koblitz, JD, and Dr. Michael Thorpy, review the FDA approval process, explore how “tentative approval” is currently impacting treatment in the field of sleep medicine, and discuss how “non-drug” issues are related to delayed FDA approval. Review the latest safety and efficacy pivotal trial data associated with once-nightly sodium oxybate and find out if we’re truly on the cusp of a new awakening in sleep medicine.

“Tentative Approval”: Understanding the FDA Ruling on Once-Nightly Sodium Oxybate

Primary Care Today features conversations with clinical experts representing a wide range of medical specialties to highlight the latest trends in primary care practice, from clinical pearls to updated guidelines, health informatics, and practice management. This series is hosted by Dr. Brian McDonough, a nationally recognized clinical expert, teacher, and public speaker in primary care.

Science & Medicine

Natural Sciences

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Medicine

Health

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Fitness & Nutrition

Host: Jennifer Caudle, DO 


  Guest: Victoria A. Statler, MD, MSc 



  
    Test-confirmed influenza outcomes provide a specific measure of influenza vaccine effectiveness (VE) and has helped to illustrate the potential benefit of cell-based versus egg-based vaccines.1 So what data support improved VE from cell-based flu vaccines versus egg-based vaccines? To learn more, join Dr. Jennifer Caudle as she speaks with Dr. Victoria A. Statler, Associate Professor of Pediatrics at the University of Louisville and the Director of the Pediatric Transplant and Immunocompromised Host service at Norton Children’s Hospital. Reference:  Stein AN, Mills C, McGovern, et al. Superior effectiveness of cell-based versus egg-based quadrivalent influenza vaccines against test-confirmed influenza over three consecutive seasons in the United States. Paper presented at: The Ninth European Scientific Working Group Influenza (ESWI) Influenza Conference; September 17-20, 2023: Valencia, Spain.  USA-QIVc-23-0119 01/24

Maximizing Flu Protection: The Clinical Value of Cell-Based Vaccines

Guess what? The CDC's Advisory Committee on Immunization Practices had a unanimous vote in favor of a preferential recommendation of vaccines for the cool adults who are 65 and older—one of these options is adjuvanted influenza vaccines.1 Talk about a milestone in the world of public health! Now the burning question is why on earth did they decide on adjuvant vaccines? Let's unravel this immunization mystery together, shall we? Reference:  Grohskopf LA, Blanton LH, Ferdinands JM, Chung JR, Broder KR, Talbot HK, Morgan RL, Fry AM. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices - United States, 2022-23 influenza season. MMWR Recomm Rep. 2022 Aug 26;71(1):1-28. doi: 10.15585/mmwr.rr7101a1  USA-CRP-23-0037 12/23

Adjuvanted Vaccines: The Modern Era in Flu Prevention for Older Adults

Host: Charles Turck, PharmD, BCPS, BCCCP 


  Guest: Wendy Wright, DNP 


  Guest: Elias Chahine, PharmD, FCCP, FASCP 



  
    While the flu may seem benign to some, it may result in up to 710,000 hospitalizations and up to 52,000 deaths every year.1 So how are current and concerning trends in declining flu vaccinations being addressed? To hear the latest updates and recommendations, join Dr. Charles Turck as he speaks with Dr. Wendy Wright, Owner and Family Nurse Practitioner at Wright & Associates Family Healthcare in New Hampshire, and Dr. Elias Chahine, Professor of Pharmacy Practice at Palm Beach Atlantic University in West Palm Beach, Florida and Clinical Pharmacy Specialist at Wellington Regional Medical Center. Reference:  Disease Burden of Influenza. Centers for Disease Control and Prevention. https://www.cdc.gov/flu/about/burden/index.html. Updated October 4, 2022. Accessed November 28, 2023.  USA-CRP-23-0043 01/24

Vax Myths Unveiled: Navigating Flu Vaccine Misconceptions

Several factors impact vaccine effectiveness from year to year. One of them is the phenomenon of strain mismatch which may result from egg adaptation during the egg-based influenza vaccine manufacturing process.1 So what exactly is the process of egg-adaptation? Gather your esteemed colleagues from far and wide, and tune into this episode of World of Tomorrow to learn more. Reference:  Rajaram S, Boikos C, Gelone DK, Gandhi A. Influenza vaccines: the potential benefits of cell-culture isolation and manufacturing. Ther Adv Vaccines Immunother. 2020;8:1-10.   USA-CRP-23-0021 11/23

Eureka for Influenza Prevention! Cell-Based Vaccines of the Future

Host: Joyce Riley 


  Guest: Lance Sloan, MD 



  
    Pneumococcal vaccination isn’t restricted to a specific season. Patients can get vaccinated with Prevnar 20 at any time. Clinicians can help their patients better understand the importance of pneumococcal vaccination. Join Joyce Riley as she gets expert insights from Dr. Lance Sloan, Endocrinologist, Nephrologist, and Metabolist in Lufkin, Texas.     Continuing medical education credits are not available for this program.© 2023 Pfizer Inc. All rights reserved. PP-PRV-USA-0378 

“Tentative Approval”: Understanding the FDA Ruling on Once-Nightly Sodium Oxybate

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