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CMS Finalizes Transitional Coverage for Emerging Technologies (TCET) Pathway

  • The Centers for Medicare & Medicaid Services (CMS) has finalized the Transitional Coverage for Emerging Technologies (TCET) pathway to expedite Medicare coverage of breakthrough devices.
  • The TCET pathway allows time-limited Medicare coverage for technologies that show promise but don't yet meet standard coverage requirements, balancing early access with evidence development.
  • CMS aims to accept up to five TCET candidates annually, striving to finalize national coverage determinations within six months of FDA market authorization.
  • The TCET pathway includes pre-market reviews, evidence previews, and evidence development plans to ensure appropriate use and benefit for Medicare beneficiaries.

Benmelstobart Plus Anlotinib Shows Superior Outcomes in Advanced Renal Cell Carcinoma

  • The combination of benmelstobart and anlotinib significantly improved progression-free survival (PFS) compared to sunitinib in advanced renal cell carcinoma (RCC).
  • The ETER100 phase 3 trial demonstrated a median PFS of 18.96 months in the combination arm versus 9.76 months in the sunitinib arm.
  • Overall response rates were notably higher in the benmelstobart plus anlotinib arm (71.6%) compared to the sunitinib arm (25.1%).
  • The combination therapy presented a manageable safety profile, aligning with the known profiles of each individual agent.

A Study of TQB2450 or Placebo Combined With Anlotinib, Etoposide and Carboplatin Versus Etoposide and Carboplatin in Subjects With Extensive Small Cell Lung Cancer (ETER701)

NCT04234607Unknown StatusPhase 3
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Posted 1/1/2020

A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer

NCT04523272Active, Not RecruitingPhase 3
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Posted 8/25/2020

iView Therapeutics Completes Enrollment in Phase 1/2 Trial of IVW-1001 for Dry Eye Disease

  • iView Therapeutics has finished enrolling patients in its Phase 1/2 clinical trial of IVW-1001, an ophthalmic eyelid wipe for treating dry eye disease.
  • The trial is a randomized, multicenter, double-masked study assessing the safety, tolerability, and efficacy of IVW-1001 at different doses compared to a placebo.
  • IVW-1001 is a novel TRPM8 agonist designed to enhance tear secretion and alleviate pain by targeting the TRPM8 channel on corneal and eyelid sensory neurons.
  • Topline data from the Phase 1/2 trial are expected in the first quarter of 2025, potentially offering a new treatment option for dry eye disease.

IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease

NCT06400459CompletedPhase 1
IVIEW Therapeutics Inc.
Posted 6/25/2024

Human Stem Cell-Derived Organoids Repair Damaged Intestines in Rodent Model

  • Researchers at Cincinnati Children's have successfully repaired damaged intestines in a rodent model using human pluripotent stem cell (hPSC)-derived organoids, marking a significant step toward clinical trials.
  • The study demonstrated that the lab-grown human tissue induced repairs across all layers of the intestine, including the mesenchyme and epithelium, with human cells forming new blood vessels.
  • Safety assessments revealed that the transplanted human cells remained localized to the repaired intestinal regions without migrating to other organs, mitigating potential risks.
  • This advancement, supported by substantial investments, paves the way for novel therapies for conditions like Crohn's disease and ulcerative colitis, addressing unmet needs in regenerative medicine.

Patritumab Deruxtecan Shows PFS Improvement in EGFR-Mutated NSCLC

  • Patritumab deruxtecan significantly improved progression-free survival (PFS) versus chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) patients after TKI failure.
  • The HERTHENA-Lung02 Phase 3 trial evaluated patritumab deruxtecan against platinum plus pemetrexed chemotherapy in patients with advanced EGFR-mutated NSCLC.
  • The safety profile of patritumab deruxtecan was consistent with previous trials, with most interstitial lung disease events being low grade.
  • Daiichi Sankyo and Merck are planning to discuss these findings with regulatory authorities for potential future approval and use.

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

NCT05338970Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 7/8/2022

A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors

NCT06172478RecruitingPhase 2
Daiichi Sankyo
Posted 2/26/2024

Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer

NCT02980341CompletedPhase 1
Daiichi Sankyo Co., Ltd.
Posted 11/28/2016

HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer

NCT04676477Active, Not RecruitingPhase 1
Daiichi Sankyo
Posted 6/11/2021

U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer

NCT03260491RecruitingPhase 1
Daiichi Sankyo
Posted 10/30/2017

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

NCT04619004Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 2/2/2021

Loyal's STAY Study: Clinical Trial Aims to Extend Healthy Lifespan in Senior Dogs

  • Loyal's STAY study is a nationwide clinical trial assessing a novel drug's ability to extend healthy lifespan in senior dogs, potentially delaying age-related metabolic dysfunction.
  • The double-blind, placebo-controlled trial involves 1,000 dogs and requires daily oral administration of the drug, with all costs covered by Loyal.
  • Participating dogs must be at least 10 years old, weigh over 14 pounds, and live near a participating veterinary clinic, excluding those with serious conditions like cancer or severe heart disease.
  • Early observations from pet owners suggest increased energy levels in dogs participating in the trial, though the study's double-blind design prevents confirmation of drug efficacy.

Arcturus Therapeutics Gains Momentum with Regulatory Approval and Clinical Advancements

  • Arcturus Therapeutics' Kostaive vaccine receives Japanese regulatory approval for updated JN.1 formulation, expected to generate $85 million in revenue.
  • The company's cystic fibrosis treatment, ARCT-032, advances to Phase 2 study after promising Phase 1/1b trial results.
  • Arcturus is awaiting European Medicines Agency (EMA) decision on Kostaive approval, anticipated in the third quarter of 2024.

Medical Marijuana Use Linked to Rapid Improvements in Quality of Life

  • A new study reveals that medical marijuana users experience rapid and significant improvements in health-related quality of life within the first three months of use.
  • Participants reported notable gains in pain reduction, increased energy levels, and enhanced emotional, social, and physical functioning.
  • The study, involving nearly 400 adults, highlights the potential benefits of medical marijuana for conditions like anxiety disorders and chronic pain.
  • Researchers emphasize the importance of understanding which patients may benefit most from specific cannabis therapies in the era of precision medicine.

Intensified Therapy Reverses Poor Prognosis in Prostate Cancer Patients with HSD3B1 Mutation

  • A new study identifies that intensified treatment with androgen deprivation therapy (ADT) plus enzalutamide improves survival for prostate cancer patients with the adrenal-permissive HSD3B1 allele.
  • The research, analyzing the ENZAMET trial, demonstrates that upfront treatment intensification can effectively block adrenal androgens, reversing the poorer prognosis typically associated with the HSD3B1 mutation.
  • Findings suggest that genetic analysis of HSD3B1 could help tailor more effective therapies for advanced prostate cancer, potentially reducing mortality and improving survival outcomes.
  • The discovery offers a significant step forward in understanding the genetics of advanced prostate cancer and focusing future clinical trials on targeted treatments.

Metformin Use Linked to Reduced Long COVID Risk in Diabetes Patients

  • A new study reveals that metformin, a common diabetes drug, may lower the risk of developing Long COVID or dying within six months of COVID-19 infection.
  • The research, analyzing data from nearly 76,000 Americans with type 2 diabetes, found a 13% to 21% reduction in Long COVID or death among metformin users.
  • Scientists speculate that metformin's protective effects may stem from its ability to reduce inflammation, decrease viral levels, and suppress disease-related protein formation.
  • The findings support earlier research suggesting metformin's potential benefits in preventing Long COVID, regardless of diabetes status.

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