MedPath

Tagged News

Bayer Submits Low-Dose MRI Contrast Agent Gadoquatrane for Global Regulatory Approval

Drug Approval
  • Bayer has submitted marketing authorization applications for gadoquatrane, an investigational MRI contrast agent that delivers 60% lower gadolinium dosing compared to standard agents while maintaining diagnostic efficacy.
  • The pivotal Phase III QUANTI studies involving 808 patients across 15 countries demonstrated non-inferior efficacy to comparator agents in visualization parameters and lesion detection with similar safety profiles.
  • Gadoquatrane represents the first low-dose macrocyclic contrast agent targeting the $3.5 billion global MRI contrast market, with particular benefits for pediatric patients and those requiring multiple lifetime scans.
  • Japan's submission marks the first regulatory application, with further global submissions planned as Bayer positions the agent to address growing safety concerns about gadolinium retention in tissues.

Five-Year Data Show Lasting Survival Benefits from Single-Dose TIL Therapy in Advanced Melanoma

Drug Approval
  • Long-term follow-up data from the C-144-01 Phase 2 trial demonstrate that lifileucel TIL therapy achieved tumor shrinkage in 79.3% of patients with treatment-refractory advanced melanoma.
  • Nearly one in five patients (19.7%) remained alive at five years following a single infusion, with 31.4% of responders maintaining their response at the five-year mark.
  • The therapy represents the first FDA-approved cellular treatment for solid tumors and is currently under regulatory review in Europe and the UK for broader clinical use.

Pembrolizumab in Treating Patients With Desmoplastic Melanoma That Can or Cannot Be Removed by Surgery

NCT02775851Active, Not RecruitingPhase 2
National Cancer Institute (NCI)
Posted 2/6/2017

Eisai's LENVIMA Combination Therapy Receives Chinese Approval for Unresectable Hepatocellular Carcinoma

Drug Approval
  • China's NMPA approved LENVIMA (lenvatinib) combined with pembrolizumab and TACE for treating unresectable, non-metastatic hepatocellular carcinoma based on Phase III LEAP-012 trial results.
  • The combination therapy demonstrated a 34% reduction in disease progression risk compared to TACE alone, with median progression-free survival extending from 10.0 to 14.6 months.
  • This approval addresses a critical unmet need in China, which accounts for over 40% of global liver cancer cases with approximately 367,000 new cases and 316,000 deaths in 2022.
  • The treatment represents a significant advancement for patients with unresectable HCC, where TACE has been standard care but many patients experience disease progression within one year.

Biocon Receives Indian Regulatory Approval for Generic Liraglutide, Expanding GLP-1 Diabetes Treatment Access

Drug Approval
  • Biocon Limited has received approval from India's CDSCO for its generic version of Victoza (liraglutide), marking the company's first vertically integrated GLP-1 diabetes therapy clearance in the country.
  • The approval covers both the drug substance and a 6 mg/ml solution for injection in pre-filled pens and cartridges, indicated for Type 2 diabetes treatment in adults, adolescents, and children aged 10 years and above.
  • With over 77 million people living with diabetes in India, this regulatory milestone addresses a critical unmet medical need and aligns with Biocon's mission to provide affordable access to lifesaving medications.
  • The company is preparing to launch the product through commercialization partners as part of its strategic focus on GLP-1 therapies as a future growth driver.

Outlook Therapeutics Launches First Approved Ophthalmic Bevacizumab in Europe for Wet AMD Treatment

Monoclonal AntibodyDrug Approval
  • Outlook Therapeutics has commercially launched LYTENAVA™ (bevacizumab gamma) in Germany and the UK, marking the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment in Europe.
  • The launch addresses a significant market need, with approximately 2.8 million injections of repackaged off-label bevacizumab administered annually in Europe for retinal diseases.
  • LYTENAVA™ has potential to mitigate certain risks associated with current off-label use of repackaged bevacizumab, while the company plans additional European launches throughout 2025 and 2026.
  • The company has partnered with Cencora to support global commercial distribution and market access, with a BLA resubmitted to the FDA for potential U.S. approval.

Vera Therapeutics' Atacicept Achieves 46% Proteinuria Reduction in Phase 3 IgA Nephropathy Trial

Drug Approval
  • Vera Therapeutics' Phase 3 ORIGIN trial met its primary endpoint, demonstrating a statistically significant 46% reduction in proteinuria versus baseline and 42% improvement over placebo (p<0.0001) at 36 weeks.
  • The company plans to submit a Biologics License Application for atacicept in Q4 2025, targeting accelerated approval for IgA nephropathy with a potential PDUFA decision by mid-2026.
  • Atacicept has received FDA Breakthrough Therapy Designation and could become a first-in-class therapy for IgAN, addressing a critical unmet need in a market affecting approximately 3 million patients globally.
  • Director Patrick Enright demonstrated strong insider confidence with a $5.28 million stock purchase in June 2025, coinciding with the finalization of Phase 3 data.

Vera Therapeutics' Atacicept Achieves 46% Protein Reduction in Phase 3 IgA Nephropathy Trial

Drug Approval
  • Vera Therapeutics' atacicept demonstrated a statistically significant 46% reduction in proteinuria in patients with IgA nephropathy, exceeding the 35% reduction seen in Phase 2 trials.
  • The positive ORIGIN 3 Phase 3 results drove Vera's stock price up over 65% in pre-market trading, with the company planning FDA submission in Q4 2025.
  • Atacicept faces competition from Otsuka Holdings' sibeprenlimab, which has already filed for FDA approval and may reach market 6-9 months earlier than Vera's drug.
  • IgA nephropathy affects up to 50% of patients who may progress to end-stage kidney disease, representing a significant unmet medical need in nephrology.

NICE Recommends Eli Lilly's Mirikizumab for Crohn's Disease Treatment Following Positive Phase 3 Trial Results

Drug ApprovalMonoclonal Antibody
  • The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending mirikizumab (Omvoh) for adults with moderately to severely active Crohn's disease who have not responded to or cannot tolerate previous biological treatments.
  • Phase 3 VIVID-1 trial results demonstrated that 45% of mirikizumab-treated patients achieved clinical remission at one year compared to 20% on placebo, with 38% showing visible intestinal healing versus 9% on placebo.
  • The recommendation comes less than two months after UK regulatory approval, with the treatment targeting interleukin-23p19 protein to reduce gastrointestinal inflammation in patients with this lifelong condition affecting over 200,000 people in the UK.

MHRA Approves Serplulimab as First Anti-PD-1 Therapy for Small Cell Lung Cancer in UK

Monoclonal AntibodyDrug ApprovalOncology
  • The UK's Medicines and Healthcare products Regulatory Agency approved serplulimab (Hetronifly) as the first anti-PD-1 monoclonal antibody for treating extensive-stage small cell lung cancer.
  • Clinical trial data showed patients receiving serplulimab with chemotherapy lived an average of 15.4 months compared to 10.9 months with chemotherapy alone.
  • The approval provides a new treatment option for an aggressive cancer type that accounts for 10-15% of lung cancer cases and typically has poor prognosis.
  • Serplulimab is administered intravenously every three weeks in combination with carboplatin and etoposide chemotherapy for first-line treatment.

A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

NCT04063163Unknown StatusPhase 3
Shanghai Henlius Biotech
Posted 9/12/2019

Sandoz Launches First Interchangeable Denosumab Biosimilars in US, Expanding Access for Osteoporosis and Cancer Patients

Monoclonal AntibodyDrug Approval
  • Sandoz has launched WYOST® and Jubbonti®, the first and only FDA-approved interchangeable denosumab biosimilars in the United States, providing cost-effective alternatives to reference medicines XGEVA® and Prolia®.
  • The biosimilars target over 10 million US adults with osteoporosis and approximately 330,000 patients living with bone metastases from cancer.
  • Both products are human monoclonal antibodies that bind to RANKL protein and are approved for all indications of their respective reference medicines with identical dosing regimens.
  • The launch represents a significant milestone in biosimilar accessibility, potentially reducing treatment costs for patients with bone-related conditions and cancer complications.

A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

NCT04757376CompletedPhase 3
Celltrion
Posted 6/17/2021

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.