Clinical Trial News
Bayer Targets Expanded Use Approval For Prostate Cancer Drug, Reveals Encouraging ...
Bayer's darolutamide plus ADT reduced radiological progression or death risk by 46% in mHSPC patients, with positive data both with and without docetaxel. The results were presented at the 2024 ESMO Congress and published in The Journal of Clinical Oncology. Bayer plans to submit the ARANOTE trial data to health authorities for expanded darolutamide use in mHSPC.
Biotronik earns expanded FDA nod for pacing lead, delivery catheter system - MassDevice
Biotronik receives FDA approval for Selectra 3D catheter and Solia S lead for left bundle branch area pacing (LBBAP), making it the first stylet-driven lead and dedicated delivery catheter system approved for this use. The products have been used in over 80,000 patients globally, with BIO-CONDUCT trial showing 95.7% implant success and 1.7% lead-related complications at three months.
Addressing Disparities in Food Allergen Immunotherapy Trials - JAMA Network
Suffian et al. found racial and ethnic disparities in food oral immunotherapy (FOIT) clinical trials, raising concerns about generalizability. They suggest addressing structural and social determinants of health to achieve health equity in FOIT research and practice.
First group of healthy volunteers dosed in QRL-101 MAD study - ALS News Today
Quralis completes dosing in Phase 1 trial of QRL-101, an oral small molecule for ALS, with 60 volunteers divided into five groups. QRL-101 targets Kv7.2/7.3 channels to reduce motor neuron hyperexcitability, with results expected in early 2025.
Epitomee Medical Announces FDA Clearance of its Capsule, Weight Management Device
The FDA has cleared Epitomee® Capsule, a drug-free, ingestible device for weight management in adults with BMI 25-40, promoting fullness and supporting diet and exercise.
Some Men with Prostate Cancer Can Benefit from Immunotherapy
Men with MMRd prostate cancer mutation had 33-month progression-free survival with dual immunotherapy, compared to 4 months for other mutations.
Apple Watch sleep apnea detection gets FDA clearance - The Verge
Emma Roth, a news writer covering streaming wars, consumer tech, crypto, social media, and more, previously a writer and editor at MUO.
Weekly review: Dupilumab, lebrikizumab FDA approved, plus much more - Contemporary Pediatrics
FDA approves dupilumab for adolescent CRSwNP, lebrikizumab for atopic dermatitis, and updated COVID-19 vaccines for all children. Research identifies metabolic markers linked to SIDS. Phase 2 data for LUM-201 in pediatric growth hormone deficiency discussed.
Ozempic Could Curb Progression of Diabetes-Linked Liver Disease
GLP-1 meds like Ozempic reduce risk of cirrhosis and death in diabetes patients with metabolic dysfunction-associated steatotic liver disease (MASLD), according to a study in JAMA Internal Medicine. Semaglutide (Ozempic/Wegovy) was particularly effective if taken early in MASLD progression. GLP-1s work by reducing body weight, blood sugar, and inflammation, potentially reversing fatty liver disease.
Three Apple Watches get FDA approval for sleep apnea detection, from today - 9to5Mac
Three Apple Watches (Series 9, Series 10, Ultra 2) receive FDA approval for sleep apnea detection, leveraging built-in accelerometer to monitor breathing disturbances during sleep, available in watchOS 11.