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Alteogen's Aflibercept Biosimilar Eyluxvi Receives Positive Opinion from European Medicines Agency

Drug Approval
  • Alteogen announced that its aflibercept biosimilar Eyluxvi (ALT-L9) received a positive opinion from the European Medicines Agency's CHMP committee, marking a decisive step toward European approval.
  • The positive recommendation is based on Phase 3 clinical trial results from 431 wet age-related macular degeneration patients across 12 countries, demonstrating therapeutic equivalence and safety compared to Eylea.
  • Eyluxvi targets the blockbuster ophthalmology market, with Eylea generating annual sales of $9.5 billion for treating conditions like wet age-related macular degeneration and diabetic macular edema.
  • This represents Alteogen's second biosimilar product following its Herceptin biosimilar ALT-L2, positioning the company for global pharmaceutical market expansion with expected approval by 2025.

Clinical Study of ALT-L9 to Determine Safety, Efficacy and Pharmacokinetics in Neovascular AMD

NCT04058535CompletedPhase 1
Alteogen, Inc.
Posted 2/5/2020

Peptide Drug Conjugates Emerge as Next-Generation Cancer Therapeutics with Over 30 Candidates in Clinical Development

Targeted TherapyOncologyDrug Approval
  • Peptide drug conjugates represent a novel targeted therapy approach that combines disease-targeting peptides with small molecule drugs to deliver treatments directly to diseased tissues while minimizing systemic toxicity.
  • The global peptide drug conjugate market has experienced remarkable growth of over 300% absolute growth and 27% CAGR from 2018-2024, with market opportunities exceeding $1.4 billion.
  • Two peptide drug conjugates have received regulatory approval as of May 2025: Novartis's Lutathera for gastroenteropancreatic neuroendocrine tumors and Oncopeptides' Pepaxti for multiple myeloma.
  • More than 30 peptide drug conjugate candidates are currently advancing through various stages of clinical trials, primarily focused on oncology applications but expanding into neurodegenerative and inflammatory disorders.

FDA Approves Rejoyn, First Prescription Digital Therapeutic for Major Depressive Disorder

Drug Approval
  • Rejoyn (CT-152) became the first FDA-approved prescription digital therapeutic for major depressive disorder on March 20, 2024, marking a significant milestone in digital mental health treatment.
  • The smartphone app is indicated as adjunctive therapy for adults aged 22 and older with MDD who are already taking antidepressants, delivering six weeks of brain training exercises and therapeutic lessons.
  • In the pivotal Mirai study of 286 patients, Rejoyn demonstrated superior efficacy with an 8.78-point reduction in MADRS scores compared to 6.66 points for the control group.
  • Clinical experience shows patients find the evidence-based digital therapeutic engaging and helpful, with some requesting to repeat the program after completion.

NeoGenomics Launches c-MET Companion Diagnostic for Advanced Non-Small Cell Lung Cancer Treatment

Targeted TherapyDrug ApprovalOncologyPrecision Medicine
  • NeoGenomics has commercially launched c-MET CDx for NSCLC, a companion diagnostic assay that detects c-Met protein overexpression in advanced non-small cell lung cancer patients with a 48-hour turnaround time.
  • The diagnostic test supports patient selection for newly FDA-approved targeted therapy EMRELIS™ (telisotuzumab vedotin-tllv), offering a precision medicine approach for a biomarker observed in up to 50% of advanced NSCLC patients.
  • This validated companion diagnostic complements NeoGenomics' broader PanTracer™ portfolio, enhancing comprehensive biomarker profiling capabilities for lung cancer treatment decisions.

Vyloy Leads Claudin 18.2 Targeted Therapy Revolution with 60+ Drug Candidates in Pipeline

Monoclonal AntibodyCAR-TDrug Approval
  • Vyloy (zolbetuximab) has emerged as the first approved Claudin 18.2-targeted therapy for HER2-negative gastric and gastroesophageal junction adenocarcinoma, marking a significant milestone in precision oncology.
  • The global Claudin 18.2 therapy market is rapidly expanding with over 60 drug candidates in clinical trials, including monoclonal antibodies, bispecific antibodies, CAR-T cell therapies, and antibody-drug conjugates.
  • China has become a major innovation hub for Claudin 18.2-targeted therapies, with companies like Innovent, MabWorks, and Biotheus leading development efforts as research expands beyond gastric cancers to other solid tumors.

A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06238843RecruitingPhase 3
Innovent Biologics (Suzhou) Co. Ltd.
Posted 6/30/2024

New Sickle Cell Disease Therapies Expand Options, But Access Barriers Remain

Drug Approval
  • Recent FDA approvals have expanded treatment options for sickle cell disease beyond hydroxyurea, including L-glutamine, crizanlizumab, and two gene therapies, marking significant progress in disease management.
  • Despite these advances, access to new therapies remains limited by age restrictions (minimum age 12), high costs, and availability primarily at large academic centers, creating barriers for many patients.
  • The global impact of these treatments is constrained as the majority of sickle cell patients live in Sub-Saharan Africa, where approximately 20 million children with the disease have little to no access to these advanced therapies.

India's CDSCO Approves Two Cancer Drugs with Phase IV Trial Requirements

Drug ApprovalMonoclonal AntibodyOrphan Drug
  • India's drug regulatory authority has approved Eli Lilly's selpercatinib tablets in multiple strengths for RET fusion-positive non-small cell lung cancer treatment.
  • Intas Pharmaceuticals received approval to import and market serplulimab, a PD-1 inhibitor monoclonal antibody for cancer treatment.
  • Both approvals come with mandatory Phase IV clinical trial requirements to be submitted within three months of marketing authorization.
  • The approvals reflect India's regulatory alignment with global standards for orphan cancer drugs already approved in major markets.

Bausch + Lomb's LUMIFY Preservative Free Eye Drops Demonstrate Non-Inferiority in Phase 3 Trial

Drug Approval
  • Bausch + Lomb's LUMIFY Preservative Free eye drops met the primary endpoint in a phase 3 study, demonstrating statistical non-inferiority to original LUMIFY drops in reducing ocular redness.
  • The randomized, active-controlled study of 380 participants showed comparable efficacy and safety profiles between preservative-free and original formulations over 4 weeks of treatment.
  • The FDA-approved preservative-free formulation provides an alternative for patients with eye sensitivities while maintaining the same fast-acting brimonidine tartrate 0.025% formula.
  • LUMIFY Preservative Free is now available nationwide at major retailers in single-use vials with a suggested retail price of $26.99.

"Efficacy and Safety of Brimonidine Tartrate Preservative-Free Formulation in Adults With Ocular Redness"

NCT05360784CompletedPhase 3
Bausch & Lomb Incorporated
Posted 5/13/2022

Uni-Bio Science Group's Diquafosol Sodium Eye Drops Receives NMPA Approval for Dry Eye Syndrome Treatment in China

Drug Approval
  • Uni-Bio Science Group has received NMPA marketing approval for 金因康® (Diquafosol Sodium Eye Drops), addressing a market of approximately 360 million individuals with dry eye syndrome in China.
  • The novel P2Y2 receptor agonist works by stimulating tear fluid and mucin secretion, offering improved tear layer normalization and corneal epithelial repair for patients with dry eye syndrome.
  • China's dry eye syndrome market is projected to reach RMB 42 billion by 2030, growing at a CAGR of 28.4%, positioning 金因康® as a significant player in the rapidly expanding ophthalmology sector.

A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD

NCT04740671CompletedPhase 3
Shanghai Henlius Biotech
Posted 7/1/2021

Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD

NCT05003245CompletedPhase 3
Shanghai Henlius Biotech
Posted 11/1/2021

Genomic Testing Emerges as Critical Tool in Brain Cancer Treatment, Experts Emphasize

OncologyTargeted TherapyDrug Approval
  • Comprehensive genomic profiling is crucial for brain cancer patients, enabling personalized treatment approaches and identification of actionable mutations like NTRK fusions, according to Dr. Manmeet Ahluwalia.
  • The recent FDA approval of vorasidenib (Voranigo) for IDH-mutant gliomas represents a breakthrough in targeted therapy for brain tumors and provides hope for developing additional brain-penetrating drugs.
  • Clinical trials remain the optimal treatment option for aggressive brain cancers like glioblastoma, with increasing availability in both academic centers and larger community practices.

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