MPR Weekly Dose

Recent regulatory and clinical developments include the approval of Weltruza — the first once-monthly subcutaneous long-acting formulation of olanzapine for schizophrenia — as well as the first subcutaneous therapy for thyroid eye disease and Hovilpri for refractory mucocutaneous HSV. In addition, the FDA expanded Tecentriq’s reach with newly approved regimens, while Vanda Pharmaceuticals reported disappointing trial results for its social anxiety disorder candidate. Hosted by Simplecast, an AdsWizz company. See https://pcm.adswizz.com

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New FDA approvals for Juvmo in Parkinson disease and Camzyos in pediatric obstructive hypertrophic cardiomyopathy, a Priority Review green light for fenebrutinib in MS, and the sudden BLA withdrawal for a key lung cancer candidate. Hosted by Simplecast, an AdsWizz company. See https://pcm.adswizz.com

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Results for weight loss treatment combo cagrilintide and semaglutide; positive results for treatment of rare form of ALS, and for sefaxersen in adults with primary IgA nephropathy; gene therapy approved for Sanfilippo syndrome; and Lyrfigtu gains approval for FGFR2+ advanced cholangiocarcinoma.

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Approvals for spinal muscular atrophy and chronic kidney disease; Joenja gains expanded approval in APDS; LSD derivative earns Breakthrough status to treat major depressive disorder; and zasocitinib is granted Priority Review for psoriasis.

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First treatment approved for Alexander disease; Hyrnuo and Etcamah are approved for lung cancer and breast cancer, respectively; Pelacarsen misses endpoint in the phase 3 HORIZON trial, and atogepant shows promise from relieving menstrual migraines.

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Mounjaro approval expanded to reduce the risk of major cardiovascular events; The American Academy of Pediatrics has issued updated recommendations for RSV immunization; BTK inhibitor shows promise in relapsing MS; and The FDA adds a boxed warning to Injectafer.

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Mounjaro approval expanded to reduce the risk of major cardiovascular events; The American Academy of Pediatrics has issued updated recommendations for RSV immunization; BTK inhibitor shows promise in relapsing MS; and The FDA adds a boxed warning to Injectafer.

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In a special episode of the MPR Weekly Dose podcast, Dr William Schaffner — professor of preventive medicine and infectious diseases at Vanderbilt University School of Medicine and former CDC Epidemic Intelligence Service officer — discusses the clinical rollout of mFlusiva, the newly-approved mRNA-based influenza vaccine. Dr Schaffner breaks down how this modern platform differs from traditional egg- and cell-based manufacturing, detailing its mechanism of action as a genetic "blueprint" and analyzing the trial data behind its approval for adults aged 50 and older.

Beyond the science, Dr Schaffner offers actionable guidance for health care providers navigating the realities of modern clinical practice. He addresses practical logistics like coadministering mFlusiva alongside routine fall immunizations, including COVID-19, RSV, and pneumococcal vaccines. He also offers empathetic strategies for overcoming vaccine hesitancy, urging clinicians to look beyond technical lectures and focus on patient reassurance and emotional comfort.

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Moderna's mRNA influenza vaccine gains FDA approval; approvals for prostate cancer, narcolepsy type 1 and Mucinex 12HR; and peanut allergy treatment gains Fast Track status.

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An over-the-counter acetaminophen/naproxen sodium fixed-dose tablet gains approval; Simtriyo approved for ADHD; Xocova approved for COVID-19 postexposure prophylaxis; A new contraceptive patch is approved; and Furoscix ReadyFlow approval is expanded to treat edema in CHF, CKD.

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