Hims & Hers Super Bowl Ad for Semaglutide "Nothing Short of Reckless," Says Partnership for Safe Medicines
In letters to the FDA and Fox Broadcasting, PSM enumerated the laws abrogated and the potential harms of the ad being viewed by 200 million people on February 9, 2025.
Opioid Prescribing Has Come a Long Way, According to Stanford Pain Expert Edward Mariano, MD, MAS
Opioid prescribing has seen its extremes, from the 5th Vital Sign era in the aughts to the CDC restrictions of 2016. Mariano talks about the environment right now.
Diabetes Caution: FDA Warns of Risk of Missing Critical Alerts from Smartphone-Compatible Diabetes Devices
Hardware or software changes as well as user adjustments may disable or mute alerts for elevated glycemia, medication use, and other diabetes management essentials, the agency said.
Viking Therapeutics Advances 3 Potential Obesity Treatments Based on Promising 2024 Clinical Trial Results
A GLP-1/GIP dual agonist in both subcutaneous and oral tablet formulations and a novel dual amylin and calcitonin receptor agonist lead the company's pipeline for antiobesity medications.
Premature Menopause May Increase Risk of Type 2 Diabetes Suggests Study of 1.1 Million Women
Premature menopause, authors said, should be included in diabetes management guidelines as a risk factor to support screening and prevention.
New ACP Guidelines on Prevention of Episodic Migraine Cite Lack of Comparative Evidence for Treatments
Pharmacologic treatment to prevent episodic migraine should follow a sequential trial approach that considers medication cost, headache triggers, adherence, and lifestyle interventions.
Delgocitinib Effective in Adolescents with CHE in Phase 3 DELTA TEEN Trial
With no FDA-approved treatments for moderate-to-severe chronic hand eczema in the teen population, the late-stage topline data are very promising.
World Cancer Day 2025: 7 Screening Recommendations from the USPSTF
World Cancer Day 2025 urges focus on the unique personal journey underlying every cancer diagnosis; individual recommendations for regular screening is where that can start.
Inhaled Psychedelic GH001 Significantly and Rapidly Reduces Symptoms in Treatment Resistant Depression in Phase 2b Clinical Trial
GH001, an inhalable 5-MeO-DMT therapy, led to a -15.5 MADRS score reduction by day 8 in patients with treatment-resistant depression.
Where Will the New Nonopioiod Suzetrigine (Journavx) Fit Best Along the Acute Pain Management Continuum? Phase 3 Investigator Shares Thoughts
Suzetrigine (Journavx) PI Todd Bertoch, MD, identifies the sweet spot where he thinks the new NaV1.8 inhibitor will be most effective in post-surgical and other moderate-to-severe acute pain.
Global Migraine Burden Rising Fastest Among Men and Adolescents, New Research Finds
The global burden of migraine rose by 58% between 1990 and 2021 to more than 1 billion, a pace projected to continue and most rapidly among men and young people.
Vaccine Distrust, Emboldened During the Pandemic, Runs Deep: An Expert Perspective
Robert Hopkins, Jr, MD, says of official communications during the COVID-19 pandemic that not enough was explained to the public about policy shifts, leaving people wondering.
Symbravo (AXS-07) for Treatment of Acute Migraine in Adults: Phase 3 Trial Primer
The pivotal INTERCEPT and MOMENTUM phase 3 clinical trials served as foundational evidence for the efficacy of the combination therapy across migraine presentations.
Pain Expert Edward Mariano, MD, MAS, Highlights Journavx and the Newly-Approved Nonopioid's Mechanism of Action
Mariano, a well-known researcher in regional anesthesiology and acute pain medicine, talks about the Journavx difference, including the drug's safety profile.
Journavx Approval: Lead Investigator Highlights Pivotal Phase 3 Clinical Trials
Todd Bertoch, MD, reviews the significant findings on relief of pain from the 2 pivotal studies and lauds the remarkable safety profile of the novel nonopoid analgesic Journavx.
FDA Approves Journavx, First-in-Class Nonopioid Analgesic for Moderate-to-Severe Acute Pain
Journavx is the first and only approved non-opioid oral pain signal inhibitor and the first new class of pain medicine approved in more than 20 years.
Axsome Therapeutics: FDA Approves Symbravo for Acute Treatment of Migraine
A single oral dose of Symbravo provided rapid migraine pain freedom and return to normal functioning within 2 hours, and sustained efficacy through 24 and 48 hours.
Tezepelumab Misses Primary Endpoint in Phase 2a COURSE Trial of Moderate to Very Severe COPD
Although the study missed the primary endpoint, subgroup analyses found variable efficacy based on baseline BECs, suggesting potential benefits in specific subgroups.
5 Drug Classes Linked to Increased Fall Risk Among Adults with COPD Near End of Life
Furosemide Fails to Reduce Risk of Dangerous de novo Postpartum Hypertension: New Research
Close monitoring for dnPPHTN during the first 2 weeks post-delivery is highly recommended for women determined to be at high risk for the hypertensive disorder of pregnancy.
Investigational Nonopioid Cebranopadol Meets Primary Endpoint in Pivotal Phase 3 ALLEVIATE-1 Clinical Trial
Cebranopadol developer Tris Pharma expects to submit an NDA to the FDA for the dual-NMR agonist to treat moderate-to-severe acute pain later this year.
Tris Pharma's Cebranopadol Shows Low Potential for Misuse in Intranasal Human Abuse Potential Study
The novel dual NMR agonist was scored significantly less "likable" when crushed and taken intranasally compared with oxycodone, the company reported.
Alzheimer Assessment Update: Alzheimer's Association Publishes New Appropriate Use Criteria for Amyloid and Tau PET
Neurocrine Biosciences Launches Phase 3 Registration Program for Osavampator in Major Depressive Disorder
The investigational and potentially first-in-class therapy may enhance AMPA receptor sensitivity to glutamate, enhancing neuronal transmission.
Patient Selection for Lecanemab to Treat Early Alzheimer Dementia: Details with R Scott Turner, PhD, MD
Dr Turner reviews the profile of the individual who is most likely to benefit from lecanemab therapy.
Enobosarm Preserves Lean Body Mass in Older Adults Treated with Semaglutide for Weight Reduction: Topline Phase 2b Data
In preliminary findings of the phase 2b QUALITY trial, 32% of weight loss in the semaglutide group was from lean mass reduction vs 9.4% in the combined semagutide/enobosarm group.
Tapinarof 1% Cream Significantly Improves Patient Reported Outcomes, Including Family QoL, in Atopic Dermatitis
Tapinarof 1% cream when used as topical monotherapy led to statistically significant and sustained improvements in QoL, sleep, and other PROs across age groups.
Lecanemab Monthly IV Maintenance Dosing: Research Highlights with R Scott Turner, PhD, MD
Georgetown University memory disorders expert R Scott Turner, PhD, MD, reviews the science behind approval of lecanemab for monthly maintenance dosing of lecanemab.
FDA Approves Monthly IV Maintenance Dosing of Lecanemab for Adults with Early Alzheimer Dementia: A First in Long-Term Disease Management
Once every four weeks maintenance dosing of lecanemab may be easier for patients and care partners to continue treatment.
3 Studies on Major Depressive Disorder: Physical, Pharmacologic, and Neuromodulatory Interventions Explored
Findings on the efficacy of treatments for MDD include the favorable effects of exercise, of CBT, and the robust outcomes of ECT among neuromodulatory modalities.
