Phase 3 Results Show Reduced Agitation in Alzheimer Patients
One evaluated dose of AVP-786 significantly improved scores in patients with moderate-to-severe agitation related to Alzheimer dementia, compared to placebo.
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Compressed Vaccination May Reduce Influenza Cases, Deaths
Modeling showed that waiting until October to vaccinate would reduce flu cases in older adults, provided vaccination rates don’t decrease and flu season doesn’t peak early.
IV Meloxicam Receives Second CRL from FDA
The FDA’s response noted that the onset and duration of intravenous meloxicam would not meet prescriber expectations for an IV drug.
FDA Issues CRL for Sotagliflozin
The FDA’s decision regarding sotagliflozin (Zynquista), an investigational treatment for type 1 diabetes, followed a split Advisory Committee vote in January.
FDA Approves Optimizer Smart Device for Chronic Heart Failure
The breakthrough device is indicated to improve 6-minute walk distance for certain patients with chronic heart failure.
Novo Nordisk Submits 2 NDAs for Oral Semaglutide
The applications seek FDA approval for blood sugar control and cardiovascular risk reduction in adults with type 2 diabetes.
FDA Accepts AR101 BLA for Peanut Allergy
The oral immunotherapy seeks approval as a treatment to reduce the risk of anaphylaxis in peanut-allergic children and adolescents following exposure to peanut.
Empagliflozin Reduces Heart Failure Re-Hospitalization, Mortality
Among participants of the EMPA-REG OUTCOME trial who experienced heart failure, empagliflozin was associated with lower rates of short-term re-hospitalization and death.
Midwest Hospital Infective Endocarditis Rates Spiked During Opioid Crisis
Admissions for infective endocarditis related to intravenous drug use increased 436% from 2012-2017 at an Ohio medical center.
Dapagliflozin Improves Measures of Left Ventricular Function in T2DM Patients
A prospective study found that daily dapagliflozin significantly improved mitral flow, left ventricular mass index, and left atrial volume index after 6 months of treatment.
Neal Walker, MD: Investigating a Topical Treatment for Warts
There are currently no FDA-approved prescription treatments for common warts, instead dermatologists must rely on painful alternatives like cutting, burning, and freezing.
Patrick Burnett, MD, PhD: Pipeline Progress of VP-102 for Molluscum Contagiosum
Following the completion of 2 pivotal trials, a new drug application for VP-102 will be submitted later this year.
FDA Expands Indication for MitraClip Valve Repair Device
Originally approved in 2013, the MitraClip is now approved for treating certain cases of secondary mitral regurgitation.
FDA Approves Venovo Stent for Iliofemoral Venous Occlusive Disease
The Venovo venous stent is the first indicated to treat this condition.
Amid Drug Shortage, FDA Approves Generic Valsartan
Recalls on Diovan (valsartan) began last July when the FDA detected trace amounts of a probable carcinogen in certain lots of the blood pressure drug.
FDA Accepts NDA for Investigational Insomnia Drug Lemborexant
An FDA decision on the application is expected by December 27, 2019.
Larry Green, MD: Efficacy of Halobetasol & Tazarotene Lotion
In a post hoc analysis, Green and colleagues examined the effect of halobetasol and tazarotene lotion on plaque psoriasis in a Hispanic population.
Larry Green, MD: Halobetasol & Tazarotene Lotion in a Hispanic Population
Green introduces the combination lotion tested in this clinical trial of patients with moderate-to-sever plaque psoriasis.
Ken Gordon, MD: Role of Placebo in the UltIMMa Trials
Even in trials like UltIMMA that compare 2 drugs, a placebo control grounds the data, says Ken Gordon, MD.
FDA Accepts Botox Applications for Pediatric Limb Spasticity
The supplemental BLAs seek to expand onabotulinumtoxinA label to treat pediatric patients with upper and lower limb spasticity.
John Durkin, MD: Benefits of Confocal Microscopy Versus Biopsy
Confocal microscopy is especially useful for diagnosing pigmented lesions, moles, melanoma, and basal cell carcinoma.
FDA Grants Priority Review to Galcanezumab for Episodic Cluster Headache
Galcanezumab was previously given a Breakthrough Therapy Designation for this indication.
John Durkin, MD: Confocal Microscopy and its Benefits
Confocal microscopy is an emerging technique that can offer a non-invasive alternative to biopsy.
Hyperhidrosis Associated with Higher Anxiety, Depression, ADD
The prevalence of anxiety, depression, and ADD was higher in patients with this excessive sweating disorder than the general population.
Ken Gordon, MD: Clinical Implications of the UltIMMa Trials of Risankizumab
Aside from the efficacy and safety of risankizumab, Gordon addresses the convenience, ease of use, and persistence of efficacy for patients with psoriasis.
Melinda Gooderham, MD: Clinical Implications of the reSURFACE 2 Trial
Gooderham addresses what the 3-year results of the reSURFACE 2 trial of tildrakizumab for plaque psoriasis mean for prescribers.
Ken Gordon, MD: Insights on Risankizumab for Plaque Psoriasis
The analysis of the UltIMMa 1 & 2 trials of risankizumab demonstrated efficacy and safety in the treatment of moderate-to-severe plaque psoriasis.
Dedee Murrell, MD: Results of the Believe-PV Pemphigus Vulgaris Trial
Investigational treatment PRN1008 demonstrated efficacy in this difficult-to-treat condition.
Melinda Gooderham, MD: 3-Year Results of the reSURFACE 2 Trial
This extension study investigated the long-term efficacy and safety of tildrakizumab for patients with plaque psoriasis.
Patrick Burnett, MD, PhD: More Data from CAMP 1 & 2
Patrick Burnett shares about the secondary endpoints and safety data of the CAMP 1 & 2 clinical trials.