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China Approves First REN-Based Migraine Wearable Device, Opening New Treatment Pathway for 130 Million Patients

Drug Approval
  • China's NMPA has approved the Nerivio® REN wearable device, marking the first and only approval of Remote Electrical Neuromodulation technology for migraine treatment in the country.
  • The drug-free, smartphone-controlled device addresses a significant unmet need among China's estimated 130 million migraine patients who face limited access to specialized care.
  • Pier 88 Health has established a comprehensive digital ecosystem integrating AI-powered patient tracking and physician support platforms to facilitate nationwide adoption of the technology.
  • The approval positions China alongside the U.S., Europe, India, and South Africa in Theranica's global rollout strategy for this neuromodulation therapy.

FDA Director Criticizes Lupus Nephritis Drug Lupkynis, Questions Surrogate Endpoint Approvals

Drug Approval
  • FDA's Center for Drug Evaluation and Research Director George Tidmarsh publicly criticized Aurinia Pharmaceuticals' lupus nephritis drug Lupkynis (voclosporin) for having "significant toxicity" without demonstrated direct clinical benefit to patients.
  • Tidmarsh stated that CDER will reevaluate the use of surrogate endpoints for drug approvals, citing concerns about companies not running trials to demonstrate benefits on hard clinical endpoints like progression to end-stage renal disease.
  • The FDA official later deleted his LinkedIn posts and clarified that his statements were personal views that do not reflect official FDA or Department of Health and Human Services positions.
  • Aurinia shares dropped 16.4% following the criticism, highlighting market sensitivity to regulatory concerns about approved therapies based on surrogate endpoints.

Novo Nordisk Resubmits FDA Application for First Once-Weekly Insulin for Type 2 Diabetes

Drug Approval
  • Novo Nordisk has resubmitted its biologics license application to the FDA for Awiqli (insulin icodec), a once-weekly basal insulin treatment for adults with type 2 diabetes.
  • The resubmission is based on results from the ONWARDS phase 3a program, which evaluated approximately 4,000 adults with type 2 diabetes across five clinical trials.
  • If approved, Awiqli would become the first once-weekly basal insulin available in the United States, potentially reducing yearly injections from 365 to 52.
  • The company prioritized the type 2 diabetes indication after FDA concerns about hypoglycemic episodes in type 1 diabetes patients led to a complete response letter in July 2024.

Kedrion Biopharma Secures FDA Approval for QIVIGY, First Proprietary IVIG Therapy for Primary Immunodeficiency

Drug ApprovalRare Disease
  • Kedrion Biopharma received FDA approval for QIVIGY, a 10% intravenous immune globulin therapy for treating adults with primary humoral immunodeficiency disorders.
  • The therapy demonstrated zero acute serious bacterial infections in a 12-month clinical study of 47 patients, meeting its primary efficacy endpoint.
  • QIVIGY represents over 10 years of internal development and will be available in the U.S. in early 2026, with global expansion planned.
  • Kedrion is investing over $415 million in U.S. infrastructure expansion, including 40 new plasma collection centers and manufacturing capacity increases.

Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients

NCT03961009CompletedPhase 3
Kedrion S.p.A.
Posted 4/30/2019

Hong Kong Accepts NDA for Dorzagliatin, World's First Glucokinase Activator for Type 2 Diabetes

Drug Approval
  • The Hong Kong Department of Health has accepted Hua Medicine's New Drug Application for dorzagliatin, the world's first approved glucokinase activator for Type 2 diabetes treatment.
  • Dorzagliatin targets the root cause of blood sugar dysregulation by repairing glucokinase function, demonstrating sustained HbA1c reduction and improved pancreatic β-cell function in Phase III trials.
  • The approval marks a strategic milestone for Hua Medicine's international expansion, positioning Hong Kong as a gateway to Southeast Asian markets serving nearly 240 million diabetes patients.
  • The drug was previously approved in China in September 2022 and added to the National Reimbursement Drug List in January 2024.

MediWound's NexoBrid Receives Marketing Authorization in Australia, Expanding Global Burn Treatment Access

Drug ApprovalOrphan Drug
  • Australia's Therapeutic Goods Administration has granted marketing authorization for NexoBrid, an innovative enzymatic therapy for burn treatment in both adult and pediatric patients.
  • The approval brings NexoBrid's global authorization to 45 countries worldwide, reinforcing its recognition as a new standard of care in burn management.
  • Commercial launch is expected in the fourth quarter of 2025 through exclusive partner Balance Medical, supported by MediWound's manufacturing expansion completion by year-end 2025.
  • The milestone opens opportunities for broader Asia-Pacific region expansion, where growing demand exists for advanced wound and burn treatments.

AbbVie's QULIPTA Gains Public Reimbursement in Quebec for Migraine Prevention

Drug ApprovalNeurology
  • Quebec's RAMQ has added QULIPTA (atogepant) to its formulary for both chronic and episodic migraine prevention, expanding access to this oral CGRP receptor antagonist.
  • The reimbursement criteria have been simplified, requiring only two failed preventive medication classes instead of three, aligning with updated Canadian Headache Society guidelines.
  • This milestone provides Quebec's migraine patients faster access to targeted therapy, with an estimated 5 million Canadians affected by this neurological condition.

Lupin Receives Tentative FDA Approval for Generic HIV Treatment Targeting $16.2 Billion Market

Drug Approval
  • Lupin Limited has received tentative FDA approval for its generic version of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, targeting a significant HIV treatment market.
  • The generic formulation is bioequivalent to Gilead Sciences' Biktarvy tablets and will be manufactured at Lupin's Nagpur facility in India.
  • The reference drug Biktarvy had estimated annual sales of USD 16.2 billion in the US, representing substantial market potential for Lupin's generic version.
  • The treatment is indicated for HIV infection in adults and pediatric patients weighing at least 25 kg, addressing a critical global health need.

Japan Approves OncoGuide OncoScreen Plus CDx System for Breast Cancer Companion Diagnostics

Drug Approval
  • Riken Genesis and Burning Rock Biotech received Japanese regulatory approval for their OncoGuide OncoScreen Plus CDx System as a companion diagnostic for AstraZeneca's capivasertib in breast cancer treatment.
  • The next-generation sequencing-based system detects PIK3CA, AKT1, and PTEN alterations in a single test to guide treatment decisions for hormone-receptor positive, HER2-negative breast cancer patients.
  • The approval supports patient selection for capivasertib combination therapy with fulvestrant, potentially expanding therapeutic opportunities for breast cancer patients in Japan.
  • Burning Rock is simultaneously advancing the product's registration application in China to benefit more breast cancer patients globally.

MacuMira Receives First Health Canada Approval for Non-Invasive Dry AMD Treatment Device

Drug Approval
  • MacuMira Medical Devices has launched the first Health Canada-approved device to improve visual function in patients with dry age-related macular degeneration.
  • The MacuMira system delivers low-dose microcurrent stimulation through closed eyelids in 32-minute sessions, now available in over 150 Canadian clinics.
  • A randomized controlled trial published in the International Journal of Retina and Vitreous demonstrated significant improvements in visual acuity and contrast sensitivity.
  • More than 15,000 treatments have been delivered across Canada, representing a breakthrough for patients who previously had limited treatment options.

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