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Clinical Trial News

Paxlovid's Efficacy Questioned in Lower-Risk COVID-19 Patients

  • A recent randomized clinical trial found that Paxlovid did not significantly reduce the duration of COVID-19 symptoms in lower-risk adults compared to placebo.
  • The study population consisted mainly of individuals under 65 with prior SARS-CoV-2 immunity and mild to moderate symptoms during the Delta and early Omicron variant periods.
  • Secondary analyses suggested a potential reduction in severe disease outcomes within a higher-risk subset, aligning with previous Paxlovid studies.
  • Experts suggest Paxlovid is unlikely to improve acute symptomatic disease outcomes for younger, healthy adults with prior vaccination or infection.

MediciNova's Ibudilast (MN-166) Shows Promise in COMBAT-ALS Trial: Interim Analysis to be Presented at International Symposium

  • MediciNova's MN-166 (ibudilast) abstract, detailing the COMBAT-ALS trial for ALS treatment, has been accepted for a poster presentation.
  • The presentation will feature an update and interim analysis results from the Phase 2b/3 COMBAT-ALS trial of MN-166 (Ibudilast) in ALS.
  • MN-166 (ibudilast) is a small molecule compound targeting PDE4 and inflammatory cytokines, currently in late-stage development for neurodegenerative diseases.
  • The poster will be presented by the trial's lead Principal Investigator, Björn Oskarsson, at the 35th International Symposium on ALS/MND in Montreal.

Withings Sleep Rx Receives FDA Clearance for Home Sleep Apnea Testing

  • Withings Sleep Rx has received FDA clearance, marking a significant advancement in sleep apnea diagnosis by offering a convenient alternative to traditional in-lab testing.
  • The device is non-intrusive, fitting under any mattress, and provides detailed analysis of sleep, breathing, and cardiovascular activity for accurate sleep apnea diagnosis.
  • Sleep Rx aims to improve access to diagnosis and patient outcomes through early detection and treatment, potentially reducing the $150 billion annual economic burden of undiagnosed sleep apnea.

Apple Watch Receives Regulatory Clearance for Sleep Apnea Detection

  • Apple Watch's new sleep apnea detection feature has been approved by both the FDA in the United States and Health Canada, paving the way for its rollout.
  • The feature, available on Apple Watch Series 9, Series 10, and Ultra 2, utilizes the accelerometer to detect breathing disturbances during sleep.
  • Apple plans to launch the sleep apnea detection feature in over 150 countries, aiming to address the widespread undiagnosed cases of this condition.
  • The technology monitors breathing patterns and notifies users of potential moderate to severe sleep apnea, encouraging them to seek medical evaluation.

Perioperative Pembrolizumab Demonstrates Survival Benefits in Early-Stage NSCLC and Advanced HNSCC

  • A Phase III trial (KEYNOTE-671) showed that perioperative pembrolizumab significantly improves overall survival in patients with resectable, early-stage non-small cell lung cancer (NSCLC).
  • In NSCLC, 71% of patients receiving pembrolizumab were alive after 36 months, compared to 64% in the placebo group, with median event-free survival of 47 months versus 18 months, respectively.
  • KEYNOTE-689 trial results indicate that perioperative pembrolizumab improves event-free survival in patients with stage III/IVA resected head and neck squamous cell carcinoma (HNSCC).
  • KEYNOTE-689 marks the first positive trial in 2 decades for patients with resected, locally advanced HNSCC, potentially changing clinical practice.

Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma

NCT02641093Active, Not RecruitingPhase 2
Trisha Wise-Draper
Posted 1/1/2016

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

NCT03765918Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 12/17/2018

Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma

NCT02296684Active, Not RecruitingPhase 2
Washington University School of Medicine
Posted 3/25/2015

Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

NCT03164616Active, Not RecruitingPhase 3
AstraZeneca
Posted 6/1/2017

A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)

NCT02775435CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 6/9/2016

Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC

NCT03625323CompletedPhase 2
Immutep S.A.S.
Posted 2/18/2019

Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

NCT03425643Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 4/24/2018

Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC

NCT04811027Active, Not RecruitingPhase 2
Immutep S.A.S.
Posted 8/27/2021

DeepWell DTx Gains FDA Clearance for Digital Therapeutic SDK Targeting Stress and Hypertension

  • DeepWell Digital Therapeutics (DTx) received FDA 510(k) clearance for its biofeedback software development kit (SDK) designed for stress reduction and hypertension management.
  • The SDK integrates into video games and other media to stimulate the vagus nerve, reduce sympathetic nervous system activation, and enhance patient engagement.
  • DeepWell's technology may qualify for reimbursement under proposed Digital Mental Health Treatment (DMHT) device codes by CMS, effective potentially in 2025.
  • The clearance enables media developers to efficiently create FDA-cleared digital therapeutics, potentially expanding access to mental and physical health support.

Dose Escalation Patterns in Psoriasis Biologic Therapies: A Swedish Registry Study

  • A Swedish registry study analyzed dose escalation patterns of adalimumab, etanercept, and ustekinumab in psoriasis treatment, revealing ustekinumab had the highest escalation frequency.
  • The study found that about 50% of adalimumab and etanercept patients discontinued treatment within a year post-dose escalation, while ustekinumab patients showed longer treatment duration.
  • Findings suggest potential cost-effectiveness concerns for adalimumab and etanercept, especially with biosimilar availability, and highlight the need for further research comparing dose escalation strategies.

Aumolertinib Significantly Improves PFS in Stage III EGFR+ NSCLC After Chemoradiotherapy

  • Aumolertinib demonstrates an 80% reduction in disease progression or death compared to placebo in patients with unresectable, stage III EGFR-mutated NSCLC after chemoradiotherapy.
  • The POLESTAR trial showed a median progression-free survival of 30.4 months with aumolertinib versus 3.8 months with placebo, as assessed by blinded independent central review.
  • Aumolertinib exhibited a favorable safety profile, with most treatment-related adverse events being manageable and lower rates of grade 3 or higher TRAEs compared to placebo.
  • The study suggests aumolertinib as a novel treatment option, significantly improving outcomes for patients with locally advanced EGFR-mutated NSCLC following chemoradiotherapy.

A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer

NCT04951635RecruitingPhase 3
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Posted 3/18/2021

Eyenovia and Formosa Pharma Launch FDA-Approved APP13007 for Postoperative Ocular Inflammation

  • Eyenovia and Formosa Pharmaceuticals have launched APP13007 (clobetasol propionate ophthalmic suspension, 0.05%) for postoperative inflammation and pain, the first FDA-approved ophthalmic drug using clobetasol propionate.
  • The U.S. ophthalmic steroid market is valued at $1.3 billion, with nearly seven million surgeries performed annually, highlighting the potential impact of APP13007.
  • APP13007's twice-daily dosing offers a more convenient and cost-effective option compared to other treatments requiring up to four doses per day.
  • Eyenovia is initiating full-scale commercialization of APP13007 in September 2024, following Formosa Pharmaceuticals' initial shipment to the U.S.

Solid Biosciences Tracks Long-Term Cardiac Effects of SGT-001 Gene Therapy for Duchenne Muscular Dystrophy

  • Long-term follow-up data from the IGNITE-DMD trial indicate preserved cardiac function in most Duchenne muscular dystrophy (DMD) patients treated with SGT-001 gene therapy.
  • The Phase 1/2 study assessed SGT-001, an AAV9 vector-based gene therapy delivering a microdystrophin gene to address the underlying cause of DMD.
  • Solid Biosciences is shifting focus to SGT-003, a next-generation gene therapy for DMD, currently under evaluation in the INSPIRE-DUCHENNE clinical trial.
  • SGT-003 leverages a novel capsid, AAV-SLB101, designed for more potent muscle transduction and contains a differentiated transgene.

A Study of SGT-003 Gene Therapy in Duchenne Muscular Dystrophy (INSPIRE DUCHENNE)

NCT06138639RecruitingPhase 1
Solid Biosciences Inc.
Posted 5/6/2024

Microdystrophin Gene Transfer Study in Adolescents and Children With DMD

NCT03368742Active, Not RecruitingPhase 1
Solid Biosciences Inc.
Posted 12/6/2017

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