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Clinical Trial News

GSK's Blenrep Receives Breakthrough Therapy Designation in China and Japan Review for Multiple Myeloma

  • GSK's Blenrep (belantamab mafodotin) gains Breakthrough Therapy Designation in China for relapsed or refractory multiple myeloma when combined with bortezomib plus dexamethasone.
  • The designation is based on Phase III DREAMM-7 trial results, demonstrating statistically significant improvements in progression-free survival compared to daratumumab plus BorDex.
  • Japan's health authority also accepted Blenrep for review in combination with BorDex or PomDex, supported by DREAMM-7 and DREAMM-8 trial data, offering new hope for patients.
  • Multiple myeloma incidence is rising in China and Japan, underscoring the need for novel treatments like Blenrep to address resistance to standard therapies.

Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

NCT04484623Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 10/1/2020

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

NCT04246047Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 5/7/2020

Psychedelic Therapy Clinical Trials Show CNS Focus and Rise in Phase II Studies

  • A new report analyzes the increasing number of psychedelic therapy clinical trials, highlighting key trends in sponsor types, geographic distribution, and trial phases.
  • Non-industry sponsors, such as Yale University, lead in the number of psychedelic therapy trials, particularly for central nervous system (CNS) indications like depression.
  • The United States is the leading country for psychedelic therapy trials in North America, with Phase II trials outnumbering other phases since 2013.
  • The report identifies top psychedelic therapies and drugs, offering insights into trial designs, virtual components, and likelihood of approval.

Medication Review Trial Aims to Enhance Quality of Life for Elderly with Polypharmacy

  • A new trial is underway to assess the impact of structured medication reviews on the health-related quality of life (HRQoL) in older adults with polypharmacy.
  • The intervention involves clinical assessment, geriatrician supervision, and collaboration between hospital physicians and general practitioners to optimize medication plans.
  • The primary outcome is HRQoL measured by the 15D instrument at 16 weeks, with secondary outcomes including physical and cognitive function, falls, and healthcare utilization.
  • The study aims to recruit 350 patients to detect a clinically significant difference in HRQoL, contributing to improved care strategies for elderly patients.

Novo Nordisk's Obesity Drug Demand Drives Growth, Outpacing Market Projections

  • Novo Nordisk's Q2 2024 sales increased by 23.9% year-over-year, driven by strong performance in diabetes and obesity care, leading to raised full-year guidance.
  • The global obesity drugs market is projected to grow 15-fold by 2030, with Novo Nordisk poised to capitalize on this expansion with innovative treatments like Wegovy.
  • Recent positive developments, including EMA's positive opinion on Wegovy's label update and a $4.1 billion US manufacturing expansion, support Novo Nordisk's growth trajectory.
  • Analysts predict a 31.1% year-over-year revenue increase for Q3 2024, reflecting confidence in Novo Nordisk's ability to meet surging demand for obesity treatments.

SepTiC Trial Investigates Enhanced Treatment Strategies for Sepsis Patients

  • The SepTiC study aims to refine sepsis treatment by addressing key questions regarding rapid testing, fluid management, and immune system support.
  • Rapid PCR testing is being used to identify infections quickly, potentially reducing the use of broad-spectrum antibiotics and combating antimicrobial resistance.
  • The trial is evaluating whether reducing excess fluid in patients whose condition is improving can aid organ recovery and improve outcomes.
  • Researchers are also assessing if the immune-stimulating medication GM-CSF (Sargramostim) can lower the risk of subsequent infections and enhance recovery in sepsis patients.

Ozempic and Mounjaro Show Promise in Managing Type 1 Diabetes

  • Ozempic (semaglutide) and Mounjaro (tirzepatide) demonstrate potential benefits in managing type 1 diabetes by aiding in weight loss and blood sugar control.
  • Mounjaro users experienced an 18% reduction in daily insulin dosage, indicating improved insulin resistance, according to study findings.
  • Clinical trial data reveals significant weight loss among type 1 diabetics, with 77% of Ozempic users and 93% of Mounjaro users losing at least 5% of body weight.
  • Experts emphasize the need for larger, prospective trials to fully assess the safety and efficacy of these drugs in type 1 diabetes patients with overweight or obesity.

Clarity Pharmaceuticals' 67Cu-SAR-bisPSMA Shows Promise in mCRPC Trial

  • Clarity Pharmaceuticals' SECuRE trial demonstrates a favorable safety profile for 67Cu-SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC).
  • Early data from the multi-dose cohort shows significant PSA declines, with one patient achieving a 92.3% reduction after prior therapy failure.
  • The Safety Review Committee approved continuation to the dose expansion phase based on positive safety and efficacy observations.
  • The trial's success may lead to earlier-stage prostate cancer treatment studies with 67Cu-SAR-bisPSMA.

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

NCT04868604RecruitingPhase 1
Clarity Pharmaceuticals Ltd
Posted 8/11/2021

WHO Prequalifies First Mpox Vaccine to Combat Outbreak in Africa

  • The World Health Organization (WHO) has prequalified the MVA-BN vaccine, manufactured by Bavarian Nordic, as the first vaccine against mpox.
  • This prequalification is expected to facilitate increased access to the vaccine in communities with urgent needs, particularly in Africa, to reduce transmission.
  • The MVA-BN vaccine can be administered in two doses to individuals 18 years and older, with an estimated 82% effectiveness, or a single dose with 76% effectiveness.
  • WHO's prequalification will help accelerate procurement by governments and international agencies like Gavi and UNICEF, and fast-track regulatory approvals worldwide.

FDA Approves Roche's Injectable Ocrevus for Multiple Sclerosis

  • The FDA has approved Roche's subcutaneous injectable version of Ocrevus for treating multiple sclerosis, offering a quicker 7-minute administration time.
  • The approval was based on the OCARINA II trial, demonstrating non-inferiority to the intravenous formulation regarding drug levels and similar safety profiles.
  • The injectable Ocrevus, to be available starting in October, expands treatment access by allowing administration in neurologist offices, avoiding specialized infusion centers.
  • Ocrevus targets CD20-positive B cells, key contributors to nerve cell damage, and has treated over 350,000 MS patients globally with the IV formulation.

Antibody-Drug Conjugates Linked to Peripheral Neuropathy: A Real-World Pharmacovigilance Study

  • A comprehensive analysis of the FAERS database reveals a significant association between antibody-drug conjugates (ADCs) with tubulin-binding payloads and peripheral neuropathy (PN).
  • Enfortumab vedotin exhibits a particularly strong association with PN compared to other ADCs, highlighting the need for careful monitoring in patients receiving this treatment.
  • The study identifies variations in the time to onset (TTO) and severity of PN among different ADCs, emphasizing the importance of personalized risk assessment and management strategies.
  • Trastuzumab emtansine shows the highest mortality rate among ADCs with tubulin-binding payloads, suggesting the need for heightened vigilance and proactive intervention in affected patients.

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