RESMED | MedPath

Regeneron to Acquire 23andMe for $256 Million, Expanding Genetics-Driven Drug Discovery Capabilities

3 days ago

• Regeneron Pharmaceuticals has won the bankruptcy auction for 23andMe's assets with a $256 million bid, aiming to maintain the consumer genetics service while enhancing its drug discovery platform. • The acquisition includes 23andMe's Personal Genome Service, Total Health, Research Services, and Biobank assets, but excludes the Lemonaid Health business. • Regeneron has committed to prioritizing privacy and ethical use of customer data, working with a court-appointed Customer Privacy Ombudsman to ensure compliance with existing policies.

FDA Clears First Stapler for Single-Port Robotic Surgery with da Vinci SP System

a month ago

• Intuitive Surgical received FDA 510(k) clearance for the SureForm 45 stapler, marking the first stapler designed specifically for single-port robotic surgery in the United States. • The fully-wristed stapler features SmartFire technology that continuously monitors tissue compression before and during firing, helping surgeons enhance staple line integrity and reduce tissue damage risk. • The device is cleared for use with the da Vinci SP surgical system in urologic, thoracic, and colorectal procedures, allowing surgeons greater control without relying on assistants.

ResMed Launches NightOwl: FDA-Cleared Home Sleep Apnea Test Now Available Across US

2 months ago

• ResMed's NightOwl, an FDA-cleared home sleep apnea test utilizing fingertip sensor technology, is now available nationwide to simplify obstructive sleep apnea diagnosis from patients' homes. • The disposable device records up to 10 nights of sleep data, uses auto-scoring algorithms validated against polysomnography, and integrates with ResMed's digital ecosystem to streamline diagnostic workflows. • With obstructive sleep apnea affecting nearly one billion people globally and 80% of cases remaining undiagnosed, NightOwl addresses a critical need for accessible testing as recent research shows CPAP therapy can significantly reduce mortality risk.

Bio-Rad to Acquire Stilla Technologies, Expanding Digital PCR Portfolio

3 months ago

• Bio-Rad Laboratories has entered a binding agreement to acquire Stilla Technologies, enhancing its digital PCR capabilities with Stilla's next-generation systems for applications including oncology diagnostics and infectious disease testing. • The acquisition, expected to close by Q3 2025, aims to serve the full spectrum of digital PCR applications and strengthen Bio-Rad's position in the rapidly growing global digital PCR market, projected to reach $3.68 billion by 2032. • Despite a recent 9.5% stock decline following the announcement, analysts remain optimistic about Bio-Rad's growth potential, with consensus estimates indicating a 12.2% earnings increase for fiscal 2025.

Incannex Healthcare's IHL-42X Shows Positive Pharmacokinetic Results for Obstructive Sleep Apnea Treatment

4 months ago

• Incannex Healthcare's IHL-42X, a combination of dronabinol and acetazolamide, demonstrated bioavailability in a PK study, confirming delivery of both drugs. • The PK profile of IHL-42X was similar to reference listed drugs, potentially allowing leveraging of existing safety data for FDA 505(b)(2) application. • The IHL-42X pharmacokinetic results will inform the analysis of the ongoing Phase 2/3 RePOSA trial data in obstructive sleep apnea patients. • The study reported excellent safety and tolerability for IHL-42X, with no serious adverse events, supporting its further development.

FDA Approves Zepbound as First Drug for Obstructive Sleep Apnea in Obese Adults

5 months ago

• The FDA has approved Zepbound (tirzepatide) as the first medication for treating moderate-to-severe obstructive sleep apnea (OSA) in obese adults. • Clinical trials showed Zepbound significantly reduced breathing disruptions and promoted weight loss compared to placebo, with nearly half of patients experiencing remission of OSA symptoms. • The drug is intended for use alongside a reduced-calorie diet and increased physical activity, offering a new approach to managing OSA and obesity. • While Zepbound shows promise, it's not suitable for all OSA patients, and continued weight loss is required for sustained effectiveness; common side effects include gastrointestinal issues.

ADVENT-HF Trial Shows Promise for Peak Flow-Triggered ASV in Heart Failure Patients with Sleep Apnea

8 months ago

• The ADVENT-HF trial demonstrated that peak flow-triggered adaptive servo-ventilation (ASV) devices improved sleep quality and quality of life in heart failure patients. • Unlike the SERVE-HF trial, ADVENT-HF did not find an increased risk of mortality with ASV use; mortality trended lower, though not statistically significant. • The study highlights that ASV devices are not generic, with efficacy and safety varying based on manufacturer-specific algorithms and triggering mechanisms. • ADVENT-HF used Philips Respironics BiPAP autoSV Advanced, which differs from the minute ventilation-triggered ASV used in SERVE-HF, potentially explaining the divergent outcomes.