HCPLive

The latest edition of the Provider's Digest, HCPLive's monthly newsletter spotlighting regulatory decisions and pipeline news, is now live! In our October 2024 recap, we spotlight 25 pieces of pipeline news, including 13 FDA decisions and 12 announcements of other regulatory updates. Be sure to subscribe for a recap of the therapies, companies, and individuals moving the needle in healthcare during the past month, delivered on the first Saturday of each new month! #FDANews #Healthcare #Medicine

The US Food and Drug Administration (FDA) has provided positive feedback to Aquestive Therapeutics regarding Anaphylm (epinephrine) sublingual film for the treatment of severe allergic reactions, including anaphylaxis. Announced on December 2, 2024, the FDA guidance reaffirmed the company’s plans for New Drug Application (NDA) submission in the first quarter of 2025, with no additional adult clinical trials required before application. Find out more: https://lnkd.in/er8fUZMw

Join our live upcoming broadcast to listen to Dr. Patel, Dr. Weber, MD, and Dr. Bloch discuss a new treatment option for adult patients with difficult to manage hypertension. This expert-led presentation will provide an in-depth discussion about unmet needs in hypertension. See full Prescribing Information including BOXED Warning bit.ly/3AYfsbC and Medication Guide bit.ly/4g3sSSw Register now bit.ly/3Z7LDgL

The US Food and Drug Administration (FDA) has cleared the initiation of a Phase 2 efficacy clinical trial to evaluate the investigational drug ruxoprubart for the treatment of Immunoglobulin A nephropathy (IgAN). According to NovelMed, ruxoprubart is positioned as the next generation of IgAN treatments based on its selective inhibition of the alternative pathway, an important advantage over other complement blockers of the classical pathway. Read more: https://lnkd.in/edPkQXRZ #Nephrology #FDANews #PipelineNews

Have you heard about Medical Ethics Unpacked?   In part 2 of our debut episode, hosts Dominic Sisti, PhD, of University of Pennsylvania Perelman School of Medicine, and Steve Levine, MD, Compass Pathways, explore the intricacies and nuance within the topic of medical assistance in dying and euthanasia.    Check out the preview below and use the link for more: https://lnkd.in/eZA8nkcP    #MedicalEthics #MedicalEthicsUnpacked

Sunday Spotlight 🌟: Inebilizumab was well-tolerated in people with IgG4-related disease and reduced the risk of flares by 87% compared to placebo by CD19-targeted B cell depletion in the Phase 3 MITIGATE study. These primary efficacy and safety findings were presented by primary investigator John Stone MD, MPH, the director of clinical rheumatology at Massachusetts General Hospital, and professor of medicine at Harvard Medical School, at the American College of Rheumatology (ACR) Convergence 2024 in Washington, DC. For more 🔗: https://lnkd.in/e3EDGASs

ONS-5010, an ophthalmic formulation of bevacizumab for wet age-related macular degeneration (AMD), missed the pre-specified non-inferiority endpoint in preliminary topline results reported from the NORSE EIGHT clinical trial. Outlook Therapeutics, Inc. announced plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of 2025, pending the full efficacy and safety results from NORSE EIGHT expected in January 2025. 🔗 https://lnkd.in/e9Yt8hYT

In this panel discussion on primary biliary cholangitis (PBC), panelists Nancy Reau, MD, John M Vierling, MD, FACP, FAASLD, AGAF, Ira Jacobson, MD, and Aparna Goal, MD, examine strategies for distinguishing PBC from other liver diseases with similar clinical presentations, emphasizing key diagnostic markers and assessment techniques. https://lnkd.in/eAHzqCpj #Hepatology  

New Video Series! In part 1, our panel of experts, which includes Jonathan Barratt, PhD, Shikha Wadhwani, MD, Ellie Kelepouris, MD, Brendon L Neuen, MBBS, PhD and Anuja Java, MD discuss how IgA nephropathy presents in patients, often remaining asymptomatic until significant progression occurs, and explore the various subtypes that exhibit distinct clinical features. https://lnkd.in/ebp8yuJ2

The BPROAD trial could reshape how the field sets blood pressure targets for patients with type 2 diabetes. Need a breakdown of the study? #DiabetesDialogue has you covered! In their #AHA24 recap, Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES and Natalie Bellini, DNP, FNP-BC, BC-ADM, CDCES breakdown the trial, how it compares to current guideline recommendations, and what it means for future guideline updates. Learn more: https://lnkd.in/eXVhy53J #Type2Diabetes #Hypertension #BloodPressure