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CDSCO Releases Draft Guidelines on Good Clinical Practices for Consultation

  • The Central Drugs Standard Control Organization (CDSCO) has released draft guidelines on good clinical practices (GCP).
  • These guidelines aim to standardize clinical trials and ensure data integrity in pharmaceutical research.
  • The draft is open for consultation, inviting feedback from stakeholders to refine the regulatory framework.
  • The move is expected to enhance the quality and reliability of clinical trial data in the Asia-Pacific region.

Pembrolizumab Plus Lenvatinib and TACE Improves Progression-Free Survival in HCC

  • The LEAP-012 trial demonstrated that pembrolizumab plus lenvatinib in combination with TACE significantly improved progression-free survival in patients with unresectable, nonmetastatic hepatocellular carcinoma (HCC).
  • The combination therapy reduced the risk of disease progression or death by 34% compared to TACE alone (HR = 0.66; 95% CI = 0.51–0.84; P = .0002) with a median follow-up of 25.6 months.
  • Median progression-free survival was 14.6 months for the pembrolizumab/lenvatinib-based regimen versus 10.0 months for TACE alone.
  • A trend toward improved overall survival was observed, though the data are not yet mature; the safety profile of the combination was consistent with previous studies.

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

NCT04246177Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/22/2020

FDA Approves Subcutaneous Tecentriq Hybreza for Multiple Cancer Types

  • The FDA has approved Tecentriq Hybreza, a subcutaneous formulation of atezolizumab, for various cancer indications, offering a new administration route.
  • Approval was based on the IMscin001 trial, which demonstrated comparable atezolizumab exposure between subcutaneous and intravenous administrations.
  • Tecentriq Hybreza combines atezolizumab with hyaluronidase to enhance subcutaneous tissue permeability, facilitating drug delivery.
  • The new formulation provides a faster, approximately 7-minute subcutaneous injection option compared to intravenous infusions.

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT03735121CompletedPhase 3
Hoffmann-La Roche
Posted 12/14/2018

FDA Approves Subcutaneous Ocrevus Zunovo for Multiple Sclerosis

  • The FDA has approved Ocrevus Zunovo, a subcutaneous formulation of ocrelizumab, for all forms of multiple sclerosis, including relapsing MS and primary progressive MS.
  • Ocrevus Zunovo offers a quicker 10-minute injection compared to the 2-4 hour intravenous infusion required for the original Ocrevus formulation.
  • Approval was based on the OCARINA II trial, demonstrating similar efficacy and safety profiles between subcutaneous and intravenous formulations of ocrelizumab.
  • This new formulation provides greater flexibility for healthcare providers and patients, potentially expanding treatment access to centers with limited IV infrastructure.

A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

NCT05232825Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 5/3/2022

Sanofi Ships Beyfortus in US to Protect Infants Against RSV

  • Sanofi is shipping Beyfortus (nirsevimab-alip) doses in the US to help protect infants against RSV, aiming for equitable access through partnerships with government agencies.
  • The FDA approved a new Beyfortus filling line, expanding manufacturing capacity to meet anticipated demand for the 2024/2025 RSV season.
  • Beyfortus is the first and only long-acting monoclonal antibody approved for preventing RSV lower respiratory tract disease in newborns and infants.
  • RSV affects two out of three babies in their first year, leading to significant hospitalizations; Beyfortus offers fast-acting protection without immune system activation.

EASi-KIDNEY Trial Investigates Vicadrostat for Chronic Kidney Disease

  • The EASi-KIDNEY trial will assess vicadrostat's efficacy in slowing chronic kidney disease (CKD) progression when combined with existing treatments like empagliflozin.
  • The global trial aims to enroll approximately 11,000 participants across 15-20 countries, with initial recruitment in Oxford, UK.
  • Vicadrostat, developed by Boehringer Ingelheim, previously demonstrated promising results in a Phase II trial, reducing albuminuria, a marker of kidney benefit.
  • The trial will use Protas' new Cantata platform to streamline clinical trial management and aims to provide results by 2028/2029.

Velsera Technology Drives Advanced Cancer Diagnostics with FDA Approval of Illumina TruSight Oncology Comprehensive IVD

  • Velsera's tumor profiling technology is a key component of the knowledge base supporting the Illumina TruSight™ Oncology (TSO) Comprehensive IVD results report, enhancing personalized treatment.
  • The collaboration between Velsera and Illumina, started in 2018, aims to advance cancer diagnostics and improve the accessibility of targeted therapeutics nationwide.
  • Velsera's Knowledge Base classifies cancer mutations, enabling more personalized and effective treatment plans for patients, and facilitating NGS-based diagnostics adoption.
  • The FDA-approved TruSight™ Oncology Comprehensive test simplifies the identification of important cancer biomarkers, enhancing patient care through precise biomarker identification.

Kisqali Plus Endocrine Therapy Reduces Breast Cancer Recurrence by 28.5% in Phase 3 Trial

  • Novartis' Kisqali, combined with endocrine therapy (ET), significantly reduced the risk of breast cancer recurrence by 28.5% in patients with stage II or III HR+/HER2- early breast cancer compared to ET alone.
  • The Phase 3 clinical trial data showed a sustained benefit beyond the three-year treatment period, offering a potential new treatment option for patients at risk of recurrence.
  • Novartis has submitted these results to the FDA and EMA, with an FDA decision on approval for this treatment anticipated this quarter, marking a potential advancement in breast cancer therapy.

CAR T-Cell Therapy Not Linked to Increased Risk of Second Cancers, Study Shows

  • A systematic review of over 5,500 lymphoma and myeloma patients found a 5.8% overall incidence of second primary malignancies (SPMs) after CAR T-cell therapy.
  • The risk of developing SPMs was similar between patients receiving CAR T-cell therapy and those undergoing standard of care treatments in randomized trials.
  • Hematologic malignancies were the most common SPM subtype, followed by solid tumors and nonmelanoma skin cancers, with T-cell malignancies being rare.
  • Factors like treatment setting, follow-up duration, and number of prior treatment lines were identified as potential risk factors for SPM development.

INmune Bio Announces $12 Million Offering to Advance Clinical Programs

  • INmune Bio is offering 2,341,260 shares of common stock along with warrants to raise approximately $12 million for clinical trials and corporate purposes.
  • The offering includes warrants exercisable beginning March 16, 2025, at $6.40 per share, expiring on March 16, 2030, subject to certain acceleration conditions.
  • Net proceeds will fund the Phase 2 Alzheimer's disease trial of XPro, initiate a Phase 2 trial for treatment-resistant depression, and continue INKmune programs.
  • Insider participation includes officers, directors, and employees purchasing approximately $800,000 of shares and warrants under similar terms.

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