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Clinical Trial News

FDA Approves Apple AirPods Pro 2 as Over-the-Counter Hearing Aids

  • The FDA has approved Apple's AirPods Pro 2 as the first over-the-counter (OTC) hearing aid software, expanding accessibility for adults with mild to moderate hearing loss.
  • iOS 18 will introduce a feature enabling AirPods Pro 2 users to utilize the earbuds as hearing aids, leveraging the device's noise cancellation and H2 chip.
  • This approval marks a significant step in advancing the availability and acceptability of hearing support, potentially transforming the hearing aid market.

Apple Watch Receives FDA Clearance for Sleep Apnea Detection

  • Apple's watchOS 11 has gained FDA approval for its sleep apnea detection feature, set to launch on Monday.
  • The feature monitors wrist movements during sleep to identify potential respiratory pattern interruptions, a key indicator of sleep apnea.
  • This approval follows similar clearances for sleep apnea detection in Samsung's Galaxy Watch and Apple's AirPods Pro as hearing aids, marking a growing trend of tech companies entering the health sector.

STRIDE Regimen Shows Unprecedented 5-Year Survival in Unresectable Hepatocellular Carcinoma

  • The STRIDE regimen (single tremelimumab with regular interval durvalumab) demonstrated a 19.6% overall survival rate at 5 years in patients with unresectable hepatocellular carcinoma (uHCC).
  • STRIDE sustained an overall survival benefit compared to sorafenib, with a median OS of 16.43 months versus 13.77 months, respectively, and a hazard ratio of 0.76.
  • Patients treated with STRIDE experienced deeper tumor responses and enhanced overall survival, especially those achieving disease control, compared to those treated with sorafenib.
  • The safety profile of STRIDE remained consistent with previous analyses, showing no new serious treatment-related adverse events at the 5-year data cut-off.

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

NCT03298451Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/11/2017

ESMO 2024: Immunotherapy and Novel Antibody-Drug Conjugate Show Promise in Gynecologic Cancers

  • Pembrolizumab plus chemoradiotherapy significantly improved overall survival in high-risk locally advanced cervical cancer, establishing a new standard of care.
  • In high-risk endometrial cancer, pembrolizumab added to chemotherapy after surgery showed clinically meaningful improvements in disease-free survival specifically in dMMR tumors.
  • TORL-1-23, a novel antibody-drug conjugate targeting claudin 6, demonstrated promising antitumor activity and tolerability in heavily pretreated ovarian and endometrial cancers.
  • Combination therapies and personalized medicines, including neoantigen vaccines, hold potential for future advancements in gynecologic cancer treatment.

FDA Clears Apple Watch Feature for Sleep Apnea Detection

  • The FDA has cleared Apple's new sleep apnea detection feature for Apple Watch Series 9, Series 10, and Ultra 2, accessible via a software update.
  • The feature monitors breathing disturbances using the Apple Watch's accelerometer, alerting users to consistent signs of moderate or severe sleep apnea.
  • Experts suggest the technology could increase early detection and healthcare visits, potentially reducing long-term healthcare costs associated with untreated sleep apnea.
  • While promising, healthcare professionals advise users to confirm Apple Watch data with a formal diagnosis before pursuing treatments.

FDA Approves Ebglyss (lebrikizumab-lbkz) for Moderate-to-Severe Atopic Dermatitis

  • The FDA has approved Eli Lilly's Ebglyss (lebrikizumab-lbkz) for treating moderate-to-severe atopic dermatitis in adults and children 12 years and older.
  • Ebglyss, a biologic therapy, targets the IL-13 pathway, addressing systemic inflammation linked to eczema symptoms like dry, itchy skin.
  • Clinical trials (ADvocate 1, ADvocate 2, ADhere) demonstrated significant improvements in skin clearance and itch relief compared to placebo.
  • Common adverse events included eye inflammation, injection site reactions, and shingles, with safety profiles consistent across studies.

FDA Approves Eli Lilly's Ebglyss (lebrikizumab) for Moderate-to-Severe Atopic Dermatitis

  • The FDA has approved Eli Lilly's Ebglyss (lebrikizumab) for treating moderate-to-severe atopic dermatitis in adults and children 12 years and older when topical treatments are insufficient.
  • Ebglyss, a monoclonal antibody targeting IL-13, offers a less frequent, once-monthly maintenance dosing schedule compared to existing biologics like Dupixent and Adbry.
  • Clinical trials demonstrated that 38% of patients achieved clear or almost-clear skin at 16 weeks with Ebglyss, and 77% maintained these results at one year with monthly dosing.
  • Ebglyss also provided significant itch relief, with 43% of participants reporting relief at 16 weeks, and 85% maintaining relief at one year with monthly maintenance dosing.

AstraZeneca's Imfinzi Shows Positive Results in Bladder Cancer Trial

  • AstraZeneca's Imfinzi demonstrated a statistically significant improvement in overall survival for patients with locally advanced, unresectable bladder cancer who did not progress on prior platinum-based chemotherapy.
  • The Phase III NIAGARA trial results support Imfinzi as a potential new treatment option, addressing a critical unmet need in this patient population.
  • The safety profile of Imfinzi in this trial was consistent with previous studies, reinforcing its established tolerability.
  • These findings could potentially change the standard of care for patients with advanced bladder cancer, offering a new hope for improved outcomes.

FDA Approves Biotronik Lead and Catheter for Left Bundle Branch Area Pacing

  • The FDA has approved Biotronik's lead and catheter system for left bundle branch area pacing (LBBAP), offering a new option for physiological pacing.
  • LBBAP aims to improve heart failure outcomes by pacing the heart in a more natural way compared to traditional right ventricular pacing.
  • The new system provides physicians with specialized tools designed to facilitate accurate and stable lead placement in the left bundle branch area.
  • This approval expands the options available for patients needing pacing therapy, potentially reducing the risk of heart failure progression.

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