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Lupin Receives Four FDA Observations at Pune Biotech Facility Following Pre-Approval Inspection

Drug Approval
  • Lupin's Pune biotech facility received four observations from the US FDA following a product-specific pre-approval inspection conducted from September 8-19, 2024.
  • The company committed to addressing all observations within the FDA's stipulated timeframe while maintaining cGMP quality standards across all facilities.
  • Separately, Lupin secured FDA approval for its Lenalidomide Capsules ANDA in the 2.5 mg to 25 mg range on September 18.
  • The Mumbai-based pharmaceutical company operates globally with products distributed in over 100 markets, specializing in branded generics and biotechnology products.

FDA Approves Injectable Keytruda, Marking New Era in Cancer Treatment Convenience

Drug ApprovalOncology
  • The U.S. Food and Drug Administration has approved an injectable subcutaneous form of Merck's blockbuster immunotherapy Keytruda, representing a significant advancement in cancer treatment administration.
  • This new formulation promises enhanced patient experiences and streamlined clinic operations by offering a more convenient mode of drug delivery compared to traditional intravenous administration.
  • The approval marks what the FDA describes as "a new era in cancer treatment," potentially improving accessibility and patient compliance for this widely-used immunotherapy.
  • The development comes as part of broader healthcare sector evolution, with companies reevaluating treatment delivery methods to optimize patient care and operational efficiency.

FDA Approves Subcutaneous Pembrolizumab Formulation for Solid Tumors, Reducing Treatment Time by Nearly 50%

Drug Approval
  • The FDA approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for subcutaneous injection on September 19, 2025, covering all previously approved solid tumor indications for adult and pediatric patients 12 years and older.
  • A phase 3 trial with 377 metastatic NSCLC patients demonstrated non-inferior pharmacokinetics for the subcutaneous formulation compared to intravenous pembrolizumab, with similar efficacy outcomes including 45.4% vs 42.1% objective response rates.
  • The subcutaneous formulation significantly reduces healthcare burden, cutting patient in-chair time by 49.7% and healthcare professional active treatment time by 45.7%, with injection taking only 2 minutes.
  • Safety profiles were comparable between formulations, with 47% vs 47.6% experiencing grade 3 or higher adverse events in subcutaneous versus intravenous groups respectively.

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)

NCT05722015Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 2/14/2023

Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)

NCT04956692Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 8/5/2021

A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread

NCT04810078Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 5/21/2021

Otsuka Receives Japanese Approval for NEXLETOL as Novel Non-Statin Cholesterol Treatment

Drug Approval
  • Otsuka Pharmaceutical has received approval from Japan's Ministry of Health, Labour and Welfare for NEXLETOL (bempedoic acid) to treat hypercholesterolemia and familial hypercholesterolemia.
  • NEXLETOL offers a novel mechanism of action by inhibiting ACLY enzyme upstream of statin targets, providing an alternative for patients who cannot achieve cholesterol goals with statins or experience adverse events.
  • A Phase 3 Japanese trial demonstrated NEXLETOL's efficacy with a 25.25% reduction in LDL cholesterol compared to 3.46% with placebo, showing statistical significance (p<0.001).
  • The approval establishes NEXLETOL's presence across major global markets including the United States, Europe, and Japan, with Esperion eligible for milestone payments and tiered royalties from 15% to 30% on Japanese sales.

A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia

NCT05683340CompletedPhase 3
Otsuka Pharmaceutical Co., Ltd.
Posted 2/13/2023

Alvotech Secures Japanese Approval for Three Biosimilars Including First Global Golimumab Biosimilar

Drug ApprovalMonoclonal AntibodyOncology
  • Alvotech's partner Fuji Pharma received Japanese regulatory approval for three biosimilars: AVT03 (denosumab), AVT05 (golimumab), and AVT06 (aflibercept) from the Ministry of Health, Labor and Welfare.
  • AVT05 represents the first golimumab biosimilar approved for sale in major global markets, marking a significant milestone in biosimilar development.
  • The approvals expand treatment access for multiple conditions including bone lesions, rheumatoid arthritis, and various eye disorders in the Japanese market.
  • This achievement builds on Alvotech and Fuji Pharma's successful partnership, which previously launched Japan's first Stelara biosimilar in May 2024.

European Regulators Recommend Approval for Novo Nordisk's Weekly Diabetes Combination Therapy Kyinsu

Drug Approval
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Novo Nordisk's once-weekly injectable diabetes treatment Kyinsu for adults with type 2 diabetes.
  • Kyinsu combines insulin icodec and semaglutide in a pre-filled pen injection designed for patients whose disease remains insufficiently controlled on basal insulin or GLP-1 receptor agonists.
  • The positive recommendation is based on three Phase III clinical studies demonstrating clinically relevant effects on glycemic control in target patient populations.
  • CHMP recommendations typically result in full European Commission approval within three months, which would make Kyinsu available across European markets.

FDA Approves Medtronic's Altaviva Implantable Device for Urge Urinary Incontinence

Drug Approval
  • The FDA approved Medtronic's Altaviva device on September 19, 2025, marking the first implantable tibial neuromodulation therapy that allows patients to return home with therapy already activated.
  • The minimally invasive device is implanted near the ankle without sedation or imaging and delivers electrical impulses to the tibial nerve to restore bladder-brain communication.
  • Clinical approval was supported by the TITAN 2 pivotal trial enrolling 188 patients, with the primary endpoint measuring at least 50% reduction in urge urinary incontinence episodes at 6 months.
  • The device features a 15-year battery lifespan, 30-minute recharging capability, and MRI compatibility, addressing an estimated 16 million Americans with urge urinary incontinence.

Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)

NCT05226286CompletedNot Applicable
MedtronicNeuro
Posted 1/31/2022

Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study

NCT04873271CompletedNot Applicable
MedtronicNeuro
Posted 5/11/2021

Ipsen's Bylvay Receives Japanese Approval for Rare Liver Disease PFIC, Offering First Non-Surgical Treatment Option

Drug ApprovalRare DiseaseOrphan Drug
  • Japan's Ministry of Health, Labour and Welfare has approved Bylvay (odevixibat) as the first once-daily ileal bile acid transport inhibitor for treating pruritus in progressive familial intrahepatic cholestasis patients.
  • The approval addresses a critical unmet need for approximately 100 children and infants in Japan suffering from this rare, life-threatening genetic liver disorder.
  • Clinical data from the global PEDFIC Phase III trial demonstrated that 55% of patients achieved pruritus reduction with odevixibat compared to 30% on placebo.
  • The treatment offers a non-surgical alternative for managing debilitating symptoms including severe itching, sleep disruption, and impaired cognitive development in PFIC patients.

Chugai Receives Japanese Approval for Tecentriq in Rare Lymphoma, Marking First Checkpoint Inhibitor for ENKL

Drug ApprovalMonoclonal AntibodyRare Disease
  • Chugai Pharmaceutical obtained regulatory approval from Japan's Ministry of Health, Labour and Welfare for Tecentriq (atezolizumab) to treat relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type (ENKL).
  • Tecentriq becomes the first immune checkpoint inhibitor approved in Japan for ENKL, a rare malignant lymphoma where approximately 60% of patients relapse after initial treatment with no established standard therapy after relapse.
  • The approval was based on results from the phase II ATTACK study conducted by Japanese investigators, including National Cancer Center Hospital, evaluating efficacy and safety in relapsed/refractory ENKL patients.
  • Chugai also received approval for a 4-weekly dosing regimen for existing lung cancer and breast cancer indications, providing more flexible treatment planning and reducing hospital visit burden.

IASO Biotherapeutics Reports Sustained 36-Month Efficacy Data for Fucaso CAR-T Therapy in Multiple Myeloma

CAR-TDrug Approval
  • IASO Biotherapeutics presented three-year follow-up data for Fucaso (Equecabtagene Autoleucel) at the 2025 International Myeloma Society Annual Meeting, demonstrating sustained efficacy in heavily pretreated relapsed/refractory multiple myeloma patients.
  • The complete response/stringent complete response rate among BCMA CAR-T-naïve patients increased to 88.4%, with a median progression-free survival of 35.9 months in this population.
  • The therapy maintained a manageable long-term safety profile with no new safety signals identified over the 36-month follow-up period.
  • Fucaso represents the world's first fully human anti-BCMA CAR-T therapy, approved by China's NMPA in June 2023, with ongoing global registration efforts across multiple countries.

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