FDA Pushes Back PDUFA Date 3 Months for Tapinarof, 1% Cream for Atopic Dermatitis in Adults and Children
The standard 3-month extension is required by the FDA to review what it considered a "major amendment" to the Organon sNDA, ie, new data from ADORING 3.
Semaglutide 2.4 mg Reduces Risk for Hospitalization for Any Cause in Adults with CVD, Obesity
ObesityWeek 2024. Semaglutide 2.4 mg reduces rates of composite CV outcomes in high-risk patients without diabetes and now is shown to reduce inpatient care and length of stay.
Semaglutide 2.4 mg: Shows Superior Improvement in Liver Fibrosis, MASH Resolution in Pivotal Phase 3 Trial
Novo Nordisk announced the topline findings from the pivotal ESSENCE trial and intends to file applications in early 2025 with US and EU regulators.
The RSV Vaccine Population was Narrowed for Good Reason, says Robert Hopkins, Jr, MD, Medical Director of the NFID
ACIP recommendations for the most appropriate older population for the RSV vaccine has shifted and the NFID medical director explains why.
Eisai Announces Completion of Rolling BLA for SQ Autoinjector-Delivered Lecanemab
The autoinjector delivers a weekly maintenance dose of 360 mg lecanemab for individuals who have completed biweekly treatment initiation by IV infusion.
Sotagliflozin Setback: Cautionary FDA AdComm Vote Reflects Continued Concern for Negative Risk/Benefit Ratio in T1D with CKD
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 against recommending the SGLT1/SLGT2 inhibitor to treat adults with T1D and CKD.
Greatest Increase in Mortality from Early-Onset Colorectal Cancer Seen Among Youngest US Adults
ACG: Mortality associated with both early- and late-stage EO-CRC rose most significantly among young adults aged 20 to 44 years between 2000 and 2022, new research reveals.
New Phase 3 Data Suggest Benefits of Early Lecanemab Initiation on Alzheimer Disease Progression, Support Long-Term Safety
New data from phase 3 Clarity AD OLE trial show sustained treatment benefit among participants with low baseline tau and brain amyloid with no new safety signals.
Roche Amyloid Plasma Panel for Alzheimer Disease Demonstrates Negative Predictive Value of 96%, Company Announced
CATD 2024: The Elecsys plasma panel also demonstrated high sensitivity and specificity for AD, building strong evidence for streamlined early disease detection.
Atopic Dermatitis: Final ADORING 3 Open-Label Extension Trial Findings with Tapinarof Cream, 1% Announced
Over 80% of participants, (2 to 17 y/o) achieved clear or almost clear skin during the 48-week trial, and treatment-free intervals lasted more than 2 months.
Early Detection of Skin Cancer Will Keep Getting Better Using AI-Based Technology: Expert Perspective
Rebecca Hartman, MD, MHP, assistant professor of dermatology at Brigham and Women's Hospital and Harvard Medical School, reviews new point-of-care detection technology.
Topical Steroids Still Have a Role in Atopic Dermatitis Treatment, But It is Limited Expert Says
Topical corticosteroids, once revolutionary for treatment of atopic dermatitis, are used just sparingly today; dermatologist Mona Shahriari, MD, lists the reasons.
A Skin Cancer Triage Tool for Primary Care: One Specialist's Take on the DermaSensor Device
Dermatologist Rebecca Hartman, MD, MPH, said that reliable point-of-care screening results can help reduce unnecessary specialist referral for benign lesions.
Dermatologist Mona Shahriari, MD, Relies on Primary Care Colleagues as First-Line Prescribers for AD
Not all atopic dermatitis requires treatment by a specialist, says this dermatologist, and she collaborates regularly with her primary care colleagues.
Lead Author Rebecca Hartman, MD, MPH, Highlights Unique Design of New DermaSensor Study
The DermaSensor skin cancer screening device was pitted against clinical impressions of lesions suspected with high confidence to be melanoma. Results, here.
The DermaSensor Device vs the Dermatologist and the Pathologist: Lead Author Details New Study
Dermatologists at high volume dermatology centers referred suspicious lesions to pathology for biopsy and diagnosis. The results were compared with DermaSensor read-outs.
Knowledge Gaps in How to Manage Anaphylaxis, Epinephrine Use, Persist for Patients, Even EMS
ACAAI 2024. Two studies here showed that anaphylaxis protocols for EMS are outdated in many states and that many patients don't know how to use epinephrine.
Monotherapy with Rifaximin vs Lactulose More Effective for Reducing Recurrence of Overt Hepatic Encephalopathy: New Post Hoc Analysis
Rifaximin monotherapy may also confer a survival benefit, according to the study, which was awarded ACG Outstanding Research Award in the Liver Category.
A Melanoma Diagnosis is a 3-Part Process, Dermatologist Rebecca Hartman, MD, MPH, Explains
A rapid increase in the rate of melanoma diagnoses could be the result of multiple factors, explains the Harvard assistant professor of dermatology.
Semaglutide Linked with Reduced Risk of Alzheimer Disease in Large Observational Study
Semaglutide significantly reduced risk of a first-time diagnosis of AD in a cohort of more than 1 million, suggesting an opportunity for controlled clinical trials.
Primary Care Assessment of Suspicious Skin Lesions: A Dermatologist Highlights DermaSensor
A bothersome skin lesion is typically first seen and assessed in primary care. An AI-based point-of-care device may help enhance triage, says Rebecca Hartman, MD, MPH.
ACIP Supports Lowering Age for Pneumococcal Vaccination to 50 from 65 Years
The expanded recommendation includes shots from Merck (PCV21) and Pfizer (PCV20), and could be a "practice-changing milestone," one executive said.
Make Early Alzheimer Disease Medications Accessible to All, Now
FDA-approved early Alzheimer medications should be covered by Medicare and other insurers and made immediately available to all those who will benefit.
FDA Expands Indication for RSV Vaccine Abrysvo to Include Adults Aged 18 to 59 with Chronic Conditions
Pfizer announced the FDA approval on October 22 that makes Abrysvo now the RSV immunization with the broadest indication for adults, the company said.
FDA Updates Flublok Label with Safety Data for Pregnant Individuals
The safety data used to update the Flublok label is from a study of more than 48 000 pregnant women across multiple flu seasons, according to Sanofi.
Why is Atopic Dermatitis Prevalence Rising? Dermatologist Mona Shahriari, MD, Parses the Trends
Shahriari, assistant clinical professor of dermatology at Yale University School of Medicine, says greater understanding of the condition has expanded the population for the diagnosis.
Exclusive Physician Survey Results on GLP-1 Receptor Agonists: The Hype Is Real
Three-quarters of primary care survey respondents prescribe GLP-1 RAs for weight loss and half get questions daily about the drugs. See all the results.
Vertex Presents Phase 3 Data on Nonopioid Suzetrigine to Treat Acute Pain at Anesthesiologists' Annual Meeting
The FDA has set a PDUFA date of January 30, 2025 for the investigational oral nonopioid therapy for acute pain, which could be a first-in-class win for Vertex.
Oral Semaglutide Shows 14% Reduction in MACE in Adults with T2D, ASCVD, and/or CKD: Topline Results from Phase 3 SOUL Trial
Novo Nordisk plans to file for regulatory approval this year of an expanded label for oral semaglutide, with an indication for reduction of MACE in high-risk adults with T2D.
Atopic Dermatitis is Not "Just" Eczema: Disease Primer with Mona Shahriari, MD
Dermatology thought leader Mona Shihriari, MD, offers a brief overview of the inflammatory skin disease for primary care clinicians.
