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Sandoz Receives FDA Approval for First Denosumab Biosimilars in US and Canada

Monoclonal AntibodyDrug ApprovalOncology
  • Sandoz received FDA approval for Jubbonti and Wyost, the first and only denosumab biosimilars approved in the United States and Canada, marking a significant milestone in biosimilar development.
  • The biosimilars are approved as interchangeable with Amgen's reference medicines Prolia and Xgeva for all indications, including osteoporosis treatment and prevention of cancer-related bone complications.
  • More than 10 million US adults aged 50 and over live with osteoporosis, with half of all women over 50 experiencing an osteoporotic fracture during their lifetime.
  • The approvals are based on robust phase I and phase III clinical studies demonstrating no clinically meaningful differences from the reference medicines.

Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

NCT03974100CompletedPhase 3
Sandoz
Posted 7/2/2019

FDA Clears Sequel's twiist AID System, First Insulin Pump to Directly Measure Every Micro-Dose

Drug Approval
  • The FDA granted 510(k) clearance to Sequel Med Tech's twiist automated insulin delivery system for type 1 diabetes patients aged 6 years and older on March 18, 2024.
  • The twiist system represents the first drug delivery device capable of directly measuring the volume and flow of insulin delivered with every micro-dose, powered by Tidepool Loop technology.
  • Developed by Dean Kamen, inventor of the first insulin pump, the system aims to provide more precise insulin delivery and expanded patient choice in diabetes management.
  • The device leverages Tidepool Loop algorithm to automatically adjust insulin delivery based on continuous glucose monitor readings and predicted glucose values.

Chugai's Vabysmo Receives Japanese Approval for Retinal Vein Occlusion Treatment

Drug Approval
  • Chugai Pharmaceutical has received approval from Japan's Ministry of Health for Vabysmo (faricimab) to treat macular edema associated with retinal vein occlusion, making it the first bispecific antibody approved for this condition in Japan.
  • The approval is based on positive results from the global Phase III BALATON and COMINO studies, which demonstrated Vabysmo's ability to rapidly improve vision and reduce retinal fluid in RVO patients.
  • Retinal vein occlusion affects an estimated 28 million adults globally and 1.66 million in Japan, representing the second most common cause of vision loss due to retinal vascular diseases.

India's Indigenous CAR T-Cell Therapy Revolutionizes Cancer Treatment at One-Tenth Global Cost

CAR-TOncologyDrug Approval
  • India has successfully developed NexCAR19, its first indigenous CAR T-cell therapy for blood cancers, priced at approximately Rs 40 lakh ($50,000) compared to $400,000 in the United States.
  • Clinical trials involving 64 patients with advanced lymphoma or leukemia showed promising results, with 67% experiencing significant cancer reduction and about half achieving complete remission.
  • Unlike U.S. approved therapies that use mouse-derived antibody fragments, India's "humanized" CAR T-cells caused fewer severe side effects, with no reported neurologic complications and only 5% experiencing severe cytokine release syndrome.

Bayer's High-Dose Eylea 8mg (Aflibercept) Accepted for Review by China's NMPA Following UK Approval

Drug Approval
• China's National Medical Products Administration (NMPA) has accepted Bayer's application for Eylea 8mg (aflibercept) to treat neovascular age-related macular degeneration for regulatory review.
• The UK's Medicines and Healthcare products Regulatory Agency (MHRA) recently approved Eylea 8mg for both wet AMD and diabetic macular edema, adding to existing approvals in the US, EU, and Japan.
• Phase III PULSAR trial results demonstrated that aflibercept 8mg maintained non-inferior visual acuity compared to the standard 2mg dose, while allowing most patients to extend treatment intervals to 12 or 16 weeks.

Bispecific Antibodies: Promising Advances Amid Adoption Challenges in Cancer Treatment

Drug ApprovalOncologyCAR-TMonoclonal Antibody
  • Bispecific antibodies represent a significant advancement in cancer immunotherapy, targeting both tumor antigens and immune cells to enhance cytotoxicity without requiring patient-derived cells like CAR-T therapy.
  • Despite clinical promise with nine FDA-approved bispecific antibodies, adoption faces challenges including transition between inpatient/outpatient settings, insurance coverage, adverse event management, and financial barriers in community settings.
  • Recent approvals of Mosunetuzumab, Glofitamab, and Epcoritamab have shown impressive response rates in relapsed/refractory indolent B-cell lymphomas, with manageable toxicity profiles when using step-up dosing strategies.

Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma

NCT05783596RecruitingPhase 2
Reid Merryman, MD
Posted 7/18/2023

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

NCT04663347Active, Not RecruitingPhase 1
Genmab
Posted 11/3/2020

CAR-T Followed by Bispecific Antibodies

NCT04889716RecruitingPhase 2
Abramson Cancer Center at Penn Medicine
Posted 11/5/2021

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

NCT05409066Active, Not RecruitingPhase 3
Genmab
Posted 9/20/2022

Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL)

NCT05529524Completed
The Lymphoma Academic Research Organisation
Posted 11/7/2022

Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma

NCT05994235RecruitingPhase 2
Weill Medical College of Cornell University
Posted 11/1/2023

Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma

NCT05169658CompletedPhase 2
University of Washington
Posted 3/23/2022

Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma

NCT06006117RecruitingPhase 3
The Lymphoma Academic Research Organisation
Posted 9/5/2023

A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma

NCT04712097Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/27/2021

Innovent's Mazdutide Achieves Phase 3 Success in Chinese Obesity Trial, Paving Way for First GLP-1R/GCGR Dual Agonist Approval

Drug Approval
  • Innovent Biologics announced that mazdutide, a novel GLP-1R/GCGR dual agonist, successfully met all primary and key secondary endpoints in the GLORY-1 Phase 3 trial for weight management in Chinese adults with overweight or obesity.
  • The 48-week study of 610 participants demonstrated superior weight loss efficacy compared to placebo, with both 4 mg and 6 mg doses showing significant improvements in body weight reduction and cardiometabolic parameters.
  • Mazdutide represents the first GLP-1R/GCGR dual agonist to succeed in Phase 3 trials, with Innovent planning to submit a new drug application to China's NMPA in the near term.
  • The trial results address a critical unmet medical need in China, which has the world's highest number of obese individuals, with obesity-related deaths accounting for 11.1% of chronic disease mortality in 2019.

A Study of IBI362 in Participants With Obesity or Overweight

NCT05607680CompletedPhase 3
Innovent Biologics (Suzhou) Co. Ltd.
Posted 11/14/2022

Travere Therapeutics Advances Filspari Toward FDA Approval Following Pre-NDA Meeting

Drug Approval
  • Travere Therapeutics has completed a pre-NDA meeting with the FDA for Filspari, marking a critical regulatory milestone in the drug's development pathway.
  • The pre-NDA meeting represents a significant step forward in the company's efforts to secure FDA approval for this therapeutic candidate.
  • This regulatory engagement demonstrates Travere's commitment to advancing Filspari through the final stages of the approval process.

CRISPR/Cas9 Technology Revolutionizes CAR-T Cell Therapy: Enhancing Efficacy and Overcoming Treatment Barriers

CAR-TGene EditingDrug Approval
  • CRISPR/Cas9 gene editing technology is being integrated with CAR-T cell therapy to address key limitations including immune checkpoint inhibition, T cell exhaustion, and manufacturing challenges.
  • The technology enables precise knockout of immune checkpoint genes like PD-1 and CTLA-4, significantly enhancing CAR-T cell persistence and anti-tumor activity in preclinical studies.
  • CRISPR/Cas9 facilitates development of universal "off-the-shelf" CAR-T cells by eliminating TCR and HLA genes, potentially reducing manufacturing costs and treatment timelines from weeks to days.
  • Despite promising clinical trial results showing safety and feasibility, researchers continue addressing potential safety concerns including off-target effects and chromosomal instability.

UK Approves World's First CRISPR Gene Therapy for Sickle Cell Disease and β-Thalassemia

Drug ApprovalRare Disease
  • The UK has made a landmark decision to approve the world's first CRISPR-based gene therapy, developed by Vertex Pharmaceuticals, for treating sickle cell disease and β-thalassemia.
  • This one-time treatment offers potential transformation of patient lives by addressing the genetic root cause of these blood disorders, marking a historic milestone in gene editing technology.
  • Despite its therapeutic promise, concerns remain about the high cost of the treatment and questions about accessibility for patients in need, particularly in regions with high disease prevalence.

BEACON: A Study Evaluating the Safety and Efficacy of BEAM-101 in Patients With Severe Sickle Cell Disease

NCT05456880RecruitingPhase 1
Beam Therapeutics Inc.
Posted 8/30/2022

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