Merck's 21-Valent Adult-Specific Pneumococcal Vaccine Accrues New Phase 3 and Real World Data
The novel 21-valent pneumococcal vaccine remains on track for the FDA PDUFA date of June 17, 2024; Merck adds this new data to the body of positive evidence.
Blood-Based DNA Test Shows Sensitivity of 83% for Colorectal Cancer
Findings from the ECLIPSE clinical trial showed the blood-based cancer screening test detects 83% of people with CRC, with a specificity of 90%.
Optinose Xhance approved by FDA as first medical therapy for CRS
Now FDA approved, Optinose’s Xhance is the first nonsurgical option for chronic rhinosinusitis both with and without nasal polyps.
Madrigal's Resmetirom Wins Historic FDA Approval for Noncirrhotic NASH
Resmetirom is the first-ever drug to be approved anywhere for management of the progressive liver disease.
AstraZeneca Launches Phase 3 THARROS Trial of Breztri to Reduce Cardiopulmonary Events in COPD
THARROS is the first phase 3 RCT to evaluate an inhaled triple combination therapy for reduction of adverse cardiopulmonary events in people with COPD, says AstraZeneca.
KDIGO Releases 2024 Clinical Practice Guideline for Evaluation and Management of CKD
The KDIGO 2024 CKD Practice Guideline is the first update since the 2012 iteration and so is based on the newest research on treatment and technology available.
Antisense Molecule against MASH from Ionis Meets Primary Endpoint in Phase 2 Trial
Ionis reports the first clinical evidence that DGAT2 inhibition-driven reduction of hepatic fat correlates with improvements in MASH histologic endpoints.
Pegazofermin Enters Phase 3 ENLIGHTEN Clinical Trial Program for MASH
The 2 phase 3 trials in the 89bio ENLIGHTEN clinical trial program will evaluate the safety and efficacy of the FGF21 analog in MASH, fibrosis.
Risk of Stroke Mitigated by Even Low Levels of Physical Activity
Even activity levels considered "insufficient" by guideline standards were found protective against stroke in this new systematic review and meta-analysis.
Tapinarof Cream 1.0% Effective for Atopic Dermatitis in Persons with Skin of Color: ADORING Phase 3 Program
Study participants self-identified as Black, White, or Asian and significant proportions reached improvement of ≥75% in EASI in both in ADORING 1 and ADORING-2.
Melatonin Implicated in 11K ED Visits for Infants, Children Over 4 Years: MMWR
Melatonin products, particularly flavored gummies and tablets, were documented in 7 out of 10 ED visits for unsupervised medication exposure in children aged ≤5 years.
Semaglutide 2.4 mg (Wegovy) Wins Expanded Indication to Include Reduced Risk of MACE
The label expansion for semaglutide, based on the SELECT trial, includes data showing reduced risk of CV death of 15% and of death from any cause of 19%.
Underrepresentation of Individuals with CKD in CV Medication Trials Found Persistent Over 2 Decades
Authors: Exclusion of people with CKD from CV medication trials has left significant gaps in understanding the effectiveness of these drugs in a highly vulnerable population.
Novo Nordisk Shares Early Findings for Novel Oral Antiobesity Agent
The novel unimolecular pill amycretin combines a GLP-1 and an amylin agonist and led to weight loss of 13% at 12 weeks in a phase 1 trial that just concluded, the company said.
In Pregnant Women with T1D, Greater Time in Range Reduces Adverse Maternal, Neonatal Outcomes
Higher time in optimal glycemic range was associated with reduced risk for preeclampsia and for birth weight larger than gestational age, new research found.
Real-World Studies Show Significant HbA1c Reductions with GLP-1 RA and Freestyle Libre CGM Used Together
One study showed a significant 1.5% decrease in HbA1c 6 months after participants taking a GLP-1 RA started using the Freestyle Libre system.
FDA Clears First-Ever OTC Glucose Sensor: Dexcom Stelo Glucose Biosensor System
The Dexcom system is for adults over the age of 18 years who do not use insulin, such as individuals with T2D who use oral medications, a US population of 25 million.
Zilebesiran Reduces Uncontrolled Hypertension as Addition to Standard of Care in Phase 2 KARDIA-2 Trial
Topline KARDIA-2 findings showed zilebesiran led to clinically and statistically significant reductions in SBP on top of either a diuretic, CCB, or ARB.
Semaglutide Reduces CKD-Related Events by 24% in Population with T2D and CKD: FLOW Findings Announced
Semaglutide 1.0 mg was superior to placebo across the FLOW trial's 5-part primary endpoint with both CKD and CVD components contributing to risk reduction, said Novo Nordisk.
Rapid Progression of CKD Can Be Detected Early Using Simple Markers in Primary Care
The 3-year risk of rapid progression from CKD stage G3 was 15% in a large Danish population. Study authors identified accessible key risk factors to aid early detection.
Resmetirom for NASH: MASESTRO-NASH Phase 3 Data in NEJM Precede PDUFA Date of 3-14-2024
Resmetirom vs placebo led to significantly greater proportion of adults reaching NASH resolution without increased fibrosis and with fibrosis improvement by ≥1 stage.
Global Obesity Rates Top One Billion, Quadrupling Among Youth from 1999-2022
Obesity rates in the US over the 3 decades rose from 11.5% to 21.7% among boys and from 11.6% to 19.4% among girls. US men ranked 10th highest for obesity in 2022.
Abrysvo Efficacy Sustained in Older Adults Through Second RSV Season
The bivalent vaccine demonstrated "durable efficacy" of more than 80% over 2 RSV seasons, according to Pfizer's report of topline findings from the RENOIR trial.
Plasma Immunoassay for Alzheimer Disease Found Highly Accurate and is Commercially Available
The accuracy of the test in detecting Aβ and tau pathology underscores its potential to become an accessible and cost effective tool for Alzheimer diagnosis.
ACIP Recommends Monovalent COVID-19 Booster for Older Adults this Spring
COVID-19 hospitalizations have never fall below 6000/week, according to the ACIP; those aged 65+ have the highest inpatient rate, those aged 75+ have the highest mortality.
Semaglutide Shows Potential for Significant CVD Prevention in Analysis of Real-World Data
Analysis of heart registry data for SELECT trial-eligible adults (obesity, first MI, no diabetes) found an NNT of 49 and 5-year MACE incidence of 10.7%.
Viking Therapeutics Dual GIP/GLP-1 Mimetic Drives Weight Loss of Up to 14.7% in Phase 2 Findings
Viking's VENTURE trial met primary and all secondary endpoints, with GI-related TAEAs reported as mild/moderate and diminishing over the course of the 13-week study.
Atogepant Safe and Effective in Treatment-Resistant Episodic Migraine: ELEVATE Phase 3b Trial
Atogepant once daily reduced mean monthly headache days in adults for whom up to 4 classes of oral migraine preventives were ineffective.
Needle-free Epinephrine Delivery: Perceptions of Physicians, Patients, and Caregivers
AAAAI 2024. Needle phobia is just one of the barriers to not just using an epinephrine autoinjector but to carrying one at all, according to 2 sets of surveys findings.
Survodutide, Dual Glucagon/GLP-1 Mimetic, Improves MASH in 83% of Phase 2 Trial Participants
The statistically significant improvements in MASH with survodutide were seen without worsening fibrosis and included a relative reduction of steatosis of 30%.