MedPath

Tagged News

Novartis Receives Approval for First Malaria Treatment Designed for Newborns and Young Infants

Drug ApprovalDrug Approval
  • Novartis has received Swiss regulatory approval for Coartem Baby, the first malaria treatment specifically formulated for newborns and infants weighing 2-5 kilograms.
  • The approval addresses a critical treatment gap, as existing malaria drugs were only tested in children aged 6 months and older, creating dosing risks for babies with immature liver function.
  • The new treatment will be rolled out in African countries within weeks on a largely not-for-profit basis, targeting regions where malaria caused 597,000 deaths in 2023.
  • Eight African nations participated in the approval process and are expected to be among the first to access the medicine, which is dissolvable in breast milk and has a sweet cherry flavor.

FDA Approves First Xolair Biosimilar Omlyclo for Allergic Diseases, Marking Milestone in Allergy Treatment Access

Monoclonal AntibodyDrug Approval
  • The FDA has approved Omlyclo (omalizumab-igec) as the first biosimilar interchangeable with Xolair for treating allergic asthma, chronic rhinosinusitis with nasal polyps, chronic urticaria, and food allergies.
  • Omlyclo demonstrated comparable efficacy and safety to Xolair in a Phase 3 clinical trial involving 619 adults with chronic spontaneous urticaria, with similar itch severity improvements and adverse event rates.
  • The biosimilar will not be available until September 2026 due to Xolair's patent exclusivity, but is expected to cost 15-35% less than the reference drug.
  • Pharmacists can substitute Omlyclo for Xolair without physician consultation due to its interchangeable designation, potentially broadening access to this important allergy medication.

To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria

NCT04426890CompletedPhase 3
Celltrion
Posted 12/9/2020

Sirtex Medical's SIR-Spheres Y-90 Resin Microspheres Receive FDA Approval for Unresectable Hepatocellular Carcinoma

Drug Approval
  • The FDA approved SIR-Spheres Y-90 resin microspheres for treating unresectable hepatocellular carcinoma, making it the first and only radioembolization therapy in the U.S. approved for both HCC and metastatic colorectal cancer.
  • The approval was supported by the DOORwaY90 study, which demonstrated a 98.5% overall response rate and 100% local tumor control rate in 65 patients across 18 U.S. centers.
  • The therapy uses personalized dosimetry to deliver targeted radiation directly to liver tumors, providing clinicians with expanded treatment flexibility for patients with unresectable HCC.
  • The median duration of response exceeded 300 days, highlighting the therapy's effectiveness as a liver-directed treatment with a favorable safety profile.

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

NCT02319837Active, Not RecruitingPhase 3
Pfizer
Posted 12/17/2014

Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)

NCT04657081Active, Not RecruitingPhase 1
Taiho Oncology, Inc.
Posted 2/9/2021

Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients

NCT04736121Active, Not RecruitingNot Applicable
Sirtex Medical
Posted 5/28/2021

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer with EGFR or HER2 Mutation (WU-KONG1)

NCT03974022Active, Not RecruitingPhase 1
Dizal Pharmaceuticals
Posted 7/9/2019

Scottish Health Authority Approves Theramex's Abaloparatide for High-Risk Osteoporosis Treatment

Drug ApprovalDrug Approval
  • The Scottish Medicines Consortium has recommended Theramex's Eladynos (abaloparatide) for treating osteoporosis in postmenopausal women at very high risk of fracture through NHS Scotland.
  • Over 1,000 postmenopausal women in Scotland are expected to benefit from this anabolic therapy, which promotes new bone formation through daily injections for up to 18 months.
  • Hip fractures cost the NHS £2 billion annually, with total osteoporotic fracture costs exceeding £4.6 billion and projected to reach £6 billion by 2030.
  • The approval follows NICE's previous recommendation in August 2024 for England, Wales, and Northern Ireland, ensuring equitable access across the UK.

Pakistan Approves Chinese Biosimilar Cancer Drug to Expand Access to Affordable Bevacizumab Treatment

Drug ApprovalOncology
  • Pakistan's drug regulator has approved a biosimilar version of bevacizumab, a costly cancer drug, manufactured by Chinese firm TOT Biopharm and marketed by Kexing Biopharm.
  • The approval addresses critical healthcare needs in Pakistan, where over 118,000 cancer deaths occur annually, with lung, colorectal, and ovarian cancers among major contributors.
  • The biosimilar offers a more affordable alternative to Roche's Avastin, which costs several hundred dollars per dose and remains unaffordable for most patients in the country of 240 million people.
  • This development strengthens Pakistan-China health cooperation and aligns with Pakistan's 2018 drug pricing policy promoting generic and biosimilar medicines to reduce healthcare costs.

Amicus Therapeutics Secures Japan Approval for Pombiliti + Opfolda Combination Therapy for Late-Onset Pompe Disease

Drug ApprovalRare Disease
  • Japan's Ministry of Health, Labour and Welfare has approved Pombiliti + Opfolda for treating adult patients with late-onset Pompe disease, expanding global access to this innovative therapy.
  • The approval was based on data from the Phase 3 PROPEL study, which uniquely studied both treatment-naïve and treatment-experienced patients in a controlled setting.
  • Pombiliti + Opfolda is now approved in seven major markets including the US, EU, UK, Canada, Australia, Switzerland, and Japan.
  • The two-component therapy combines a recombinant human GAA enzyme with enhanced muscle cell uptake and an oral enzyme stabilizer designed to maintain enzyme activity in blood.

Thailand Achieves Pharmaceutical Independence with First Domestically Produced Targeted Cancer Drugs

Targeted TherapyDrug Approval
  • Thailand has developed its first domestically produced targeted cancer drugs, IMCRANIB 100 and HERDARA, without foreign technology transfer, marking a historic milestone in pharmaceutical independence.
  • IMCRANIB 100 targets multiple cancers including chronic myeloid leukemia and gastrointestinal stromal tumors by inhibiting tyrosine kinase enzyme, while HERDARA serves as a cost-effective alternative to trastuzumab for breast cancer treatment.
  • The breakthrough addresses the financial burden of imported cancer drugs, with trastuzumab previously costing up to 1 million baht per course, significantly improving treatment accessibility under Thailand's universal healthcare system.
  • Production takes place at Thailand's first internationally certified cancer drug manufacturing facility, established in 2020 at the Royal Pharmaceutical Manufacturing Plant in Chonburi Province.

Everest Medicines Advances AI-Powered mRNA Platform with Cancer Vaccine Breakthroughs

Drug ApprovalCAR-TAI
  • Everest Medicines unveiled major breakthroughs in its proprietary AI-powered mRNA platform during its 2025 R&D Day, showcasing a fully integrated system spanning antigen design to manufacturing.
  • The company's personalized cancer vaccine EVM16 demonstrated robust immunogenicity and mutation-specific T-cell responses in early clinical trials, while off-the-shelf vaccine EVM14 received FDA IND clearance.
  • Everest's innovative in vivo CAR-T program achieved high T-cell transduction efficiency and effective B-cell clearance in preclinical studies, offering a scalable alternative to conventional CAR-T therapies.
  • The company is pursuing global partnerships with top 20 pharmaceutical companies to accelerate international deployment of its clinically validated mRNA assets.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.