FDA Proposes Sustained 5% Weight Loss to Establish Efficacy of New Antiobesity Medications
In an unusual step, the agency's draft guidance recommends the efficacy benchmark for drug approval while emphasizing clinical trial structure and cohort development.
Migraine Therapeutics Research that Made News with Neurologists in 2024: Interview with Peter McAllister, MD
Significant strides were made in 2024 in evaluating a wide range of treatments for migraine, including phase 2 findings with PACAP inhibition, PI McAllister said.
Results of Novel Assay Shed Light on Impact of Lecanemab on Neurodegeneration in Alzheimer Disease
The first study to quantify lecanemab-captured Aβ-PF species in human CSF shows a strong correlation with neurodegeneration and may help explain the drug's MOA.
9 Fast Fact about Avian Influenza for Primary Care
The bird flu threat remains low, according to public health authorities, but awareness and vigilance will help keep it that way. Here are 9 things you need to know.
Bird Flu: First US Death Reported, NIH Updates Risk Assessment
The first death of an American from the H5N1 virus was reported in Louisiana on Monday, though authorities maintain the risk of widespread infection remains low.
The Electrical Origins of Migraine May be Under the Microscope, Neurologist Peter McAllister, MD, Explains
The onset of migraine with its wide range of symptoms may be telegraphed as early as 2 days before by the frequency of neuronal oscillation deep in the brain.
Neumora Therapeutics Reports Disappointing Results from Phase 3 Study of Navacaprant in MDD
The failure of the novel kappa opioid receptor antagonist to best placebo in the first of triplicate phase 3 studies has Neumora concerned but not deterred.
Novel Nonopioid Dual Action Analgesic Highly Effective Against Post-Surgical Pain in Phase 2b Trial
The new chemical entity from Xgene Pharmaceuticals, XG005, targets both anti-nociceptive and anti-neuropathic pain pathways.
For Alzheimer Agitation, a Novel, Oral NMDA Inhibitor Could be the Next Targeted Treatment
Geriatric psychiatrist and neurocognitive researcher George Grossberg, MD, highlights the mechanism of action for the new dextromethorphan/bupropion combination.
Axsome Completes Phase 3 Clinical Program with AXS-05 in Alzheimer Disease Agitation
Axsome plans to submit a New Drug Application to the FDA in the second half of 2025 that is based on positive results from 4 pivotal phase 3 clinical trails and long-term data.
US Adolescent Substance Use Holding Steady or Declining: Highlights from the 2024 Monitoring the Future Survey
Substances of choice used in the previous 12 months were alcohol, nicotine vaping, and cannabis but the trends among the 8th, 10th, and 12th graders are very encouraging.
FDA Adds Black Box Warning to Fezolinetant Label, Advising of Rare but Serious Liver Injury
The black box warning, the agency's most prominent alert, follows earlier additions to the original fezolinetant label about hepatic injury and regular LFT testing.
Crinecerfont for Congenital Adrenal Hyperplasia Now Commercially Available, Neurocrine Biosciences Announces
The first in class CRF-1 receptor antagonist allows people with CAH to reduce glucocorticoid doses while androgen levels are maintained or improved.
CagriSema Leads to Weight Reduction of Approximately 23% in Phase 3 REDEFINE 1 Clinical Trial, Short of the 25% Expected
The 22.7% weight loss at 68 weeks places CagriSema essentially on par with, not superior to, competing antiobesity drugs including Lilly's tirzepatide.
Women are at Higher Genetic Risk for PTSD than Men, According to Large Twin-Sibling Study
In the largest twin-sibling study to date of the inherited biological risk of PTSD, researchers found additive genetic and unique environmental effects contributed to the disorder.
Vertex Nonopioid Analgesic on Par with Placebo in Phase 2 Study of Lumbosacral Radiculopathy
Pain relief with suzetrigine was comparable to that seen with placebo, an issue Vertex plans to address with study design as the drug moves to the pivotal phase 3 trials.
Vaccination Information and Educational Resources from the National Foundation for Infectious Diseases
Robert Hopkins, Jr, MD, NFID medical director, details a range of resources on the foundation's website including in-depth vaccine recommendations, live webinars, plus much more.
CDC Adds Heplisav-B to Recommendations for HepB Vaccination During Pregnancy
The addition, based on an approved update to labeling, expands to 4 the recommended vaccination options that health care professionals can offer to pregnant people.
Sanofi Investigational COVID-19/Influenza Combination Vaccines Granted FDA Fast-Track Designation
The 2 novel vaccine candidates each combine a Sanofi licensed influenza vaccine with the Novavax adjuvanted recombinant COVID-19 vaccine.
A Vaccination Imperative: "Please, Let's Do It," NFID Medical Director Robert Hopkins, Jr, MD, Urges
The National Foundation for Infectious Diseases medical director appeals to the community at large to set politics and personal grievance aside and to "first, do no harm."
10 Essential Vaccine Updates for Primary Care: Winter 2024-2025
From ACIP updates on age eligibility and research on vaccine efficacy to US adults' attitudes toward recommended shots, these 10 at-a-glance news briefs are must-reads for PCPs.
FDA Accepts NDA for TNX-102 SL, Tonix Nonopioid Analgesic for Fibromyalgia
If approved, the nonopioid, centrally acting analgesic would be the first in a new class of medications for fibromyalgia in more than 15 years, Tonix said.
Expert Perspectives 2024: Breakthrough Therapy for Congenital Adrenal Hyperplasia with PI Richard Auchus, MD, PhD
The lead investigator of the largest clinical trial program in people with CAH discusses the condition, its burden, and the novel drug just approved that will change lives.
FDA Accepts Merck's BLA for Clesrovimab, an Investigational mAb Against RSV in Infants
Clesrovimab, if approved, would be the only immunization for both healthy and at risk infants using the same dose. FDA set A PDUFA date of June 2025.
FDA Receives sNDA for Roflumilast Cream 0.05% to Treat Atopic Dermatitis in Children Aged 2 to 5 Years
Arcutis Biotherapeutics announced submission of the sNDA today, citing the the supporting positive data from the phase 3 INTEGUMENT-PED and INTEGUMENT-OLE trials.
Tapinarof Cream, 1%, Gets FDA Green Light for Atopic Dermatitis in Individuals Aged 2 Years and Older
Approval for the topical nonsteroidal therapy, based on data from the phase 3 ADORING clinical trial program, helps fill a gap in current offerings for atopic dermatitis.
Richard J Auchus, MD, PhD, Details Pivotal Phase 3 Trial That Supported FDA Approval of Crinecerfont for Congenital Adrenal Hyperplasia
Auchus details findings from the unique study of the CRF-1 antagonist crinecerfont, the first new therapy for CAH approved in 70 years.
FDA Approves Crinecerfont for Congenital Adrenal Hyperplasia in Adults and Children in Landmark Decision
Crinecerfont approval makes available the first new treatment for the life-altering endocrine disorder in more than 70 years, according to Neurocrine Biosciences.
Expert Perspectives 2024: Treatment for Agitation in Alzheimer Disease with George Grossberg, MD
Agitation affects at least one half of adults with Alzheimer disease; geriatric psychiatrist Grossberg explains the symptoms and new treatments in this year's video series.
Expert Perspectives 2024: Nonsteroidal Topicals for Atopic Dermatitis with Mona Shahriari, MD
The new nonsteroidal topical treatments for atopic dermatitis are targeted and modify the disease process, explains thought leader Shahriari in this year's video series.
