MedPath

Tagged News

Basecare Medical's GEMS Culture Medium Receives NMPA Approval, Breaking 30-Year Import Monopoly in China's IVF Market

Drug Approval
  • Basecare Medical's GEMS culture medium (VitBase) has received NMPA approval, marking the first domestic registration of this internationally recognized embryo handling solution in China.
  • The approval breaks a 30-year monopoly by international manufacturers in China's embryo culture medium market and establishes Basecare as one of few companies with CE, FDA, TGA, and NMPA certifications.
  • The localized production is expected to enhance supply chain security, reduce treatment costs, and improve accessibility for Chinese IVF patients while maintaining international quality standards.
  • VitBase represents the first of 11 GEMS series products to receive Chinese registration, with the complete product line covering the entire assisted reproduction process.

UAE Grants World's First Approval for Tolebrutinib, Breakthrough Oral Treatment for Progressive Multiple Sclerosis

Drug Approval
  • The Emirates Drug Establishment has approved Tolebrutinib, making the UAE the first country to authorize this oral treatment for non-relapsing secondary progressive multiple sclerosis (SPMS).
  • Tolebrutinib represents a novel therapeutic approach as a Bruton's tyrosine kinase (BTK) inhibitor that directly targets disability progression by addressing chronic neuroinflammation in the brain and spinal cord.
  • The approval was based on a scientific study conducted in collaboration with the National Multiple Sclerosis Society, marking a significant advancement for patients with limited treatment options.
  • This breakthrough therapy specifically targets B cells and microglia within the central nervous system, offering the first treatment designed to slow disability progression independent of relapses.

FDA Expands Repatha Indication to Include Adults at High Risk for Cardiovascular Events Without Prior Disease Diagnosis

Monoclonal AntibodyDrug Approval
  • The FDA has expanded Repatha's (evolocumab) indication to include adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL cholesterol, removing the requirement for prior cardiovascular disease diagnosis.
  • Real-world data from over 1.3 million patients showed a 1.4% incidence of major adverse cardiovascular events within one year, rising to 6.9% at four years among at-risk patients.
  • Repatha, a PCSK9 inhibitor, has demonstrated 54% to 77% LDL cholesterol reduction compared to placebo in clinical trials spanning 15 years of research across 50 studies involving more than 57,000 patients.

Royalty Pharma Acquires $950 Million IMDELLTRA Royalty Rights from BeOne Medicines

Drug ApprovalOncology
  • Royalty Pharma acquired BeOne Medicines' royalty rights to IMDELLTRA (tarlatamab-dlle) for up to $950 million, with $885 million paid upfront and an option for additional $65 million within 12 months.
  • IMDELLTRA is a first-in-class DLL3-targeting bispecific T-cell engager approved for extensive-stage small cell lung cancer patients who progressed after platinum-based chemotherapy.
  • The drug generated $215 million in sales during the first half of 2025 and is projected to exceed $2.8 billion by 2035 according to analyst consensus.
  • BeOne retains China commercial rights and will share in royalties on annual sales above $1.5 billion, while maintaining rights to other collaboration assets including xaluritamig.

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

NCT05060016Active, Not RecruitingPhase 2
Amgen
Posted 12/1/2021

GSK Launches First PD-1 Immunotherapy and PARP Inhibitor for Gynecological Cancers in India

OncologyDrug Approval
  • GlaxoSmithKline has introduced Jemperli and Zejula therapies in India, marking the company's entry into the oncology segment with treatments for gynecological cancers.
  • Jemperli becomes the first and only approved PD-1 immunotherapy for second-line treatment of mismatch repair-deficient/microsatellite instability-high advanced or recurrent endometrial cancer in India.
  • Zejula is positioned as the only PARP inhibitor approved as first-line monotherapy maintenance for all biomarker types in advanced ovarian cancer in India.
  • Both therapies are already trusted and approved in over 40 countries globally, addressing critical unmet medical needs in women's cancer care.

PBAC Rejects PBS Listing for Alzheimer's Drug Donanemab Despite Clinical Need

Drug ApprovalMonoclonal Antibody
  • The Pharmaceutical Benefits Advisory Committee (PBAC) rejected Lilly's application for PBS listing of donanemab (Kisunla), the first new Alzheimer's treatment registered in Australia in 25 years.
  • While clinical trials showed donanemab can delay early Alzheimer's disease progression by approximately six weeks, PBAC found the benefits too small and uncertain to justify the treatment burden.
  • Patients can still access the drug privately at $4,700 per infusion every four weeks for 18 months, creating significant equity concerns for those unable to afford the treatment.
  • The decision highlights ongoing challenges in balancing clinical innovation with healthcare system sustainability for Australia's aging population.

Novartis Secures Pan-Canadian Agreement for Leqvio Access in Familial Hypercholesterolemia

Drug ApprovalRare Disease
  • Novartis successfully concluded negotiations with the pan-Canadian Pharmaceutical Alliance for public reimbursement of Leqvio (inclisiran) to treat adults with heterozygous familial hypercholesterolemia.
  • The agreement represents a significant step toward addressing treatment gaps for patients with this genetic condition who face elevated cardiovascular risk from high LDL cholesterol levels.
  • While pCPA negotiations are complete, public reimbursement through provincial and territorial formularies has not yet been secured, requiring further collaboration with drug programs.
  • Since commercialization in 2022, Leqvio has treated more than 4,500 Canadians and 290,000 patients worldwide following Health Canada approval in 2021.

Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)

NCT03397121CompletedPhase 3
The Medicines Company
Posted 11/28/2017

Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol

NCT03399370CompletedPhase 3
The Medicines Company
Posted 12/21/2017

Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol

NCT03400800CompletedPhase 3
The Medicines Company
Posted 11/1/2017

Ascentage Pharma Reports Strong Growth with 93% Increase in Olverembatinib Sales and Historic Lisaftoclax Approval

Drug Approval
  • Ascentage Pharma reported a 93% year-over-year increase in Olverembatinib sales to US$30.3 million for the first half of 2025, driven by expanded National Reimbursement Drug List coverage in China.
  • The company achieved a historic milestone with Lisaftoclax becoming the first Bcl-2 inhibitor to receive conditional approval for chronic lymphocytic leukemia/small lymphocytic lymphoma treatment in China on July 10, 2025.
  • Nine registrational Phase III clinical trials are currently ongoing, including three cleared by the FDA, demonstrating the company's robust pipeline advancement.
  • The company strengthened its financial position by completing a top-up placement in July 2025, raising US$190.1 million in net proceeds to support commercialization and development programs.

NHS Approves Breakthrough Bladder Cancer Treatment That Doubles Survival Rates

Drug ApprovalOncology
  • The NHS has approved enfortumab vedotin combined with pembrolizumab for bladder cancer patients, marking one of the most significant advances in decades for this difficult-to-treat disease.
  • Clinical trials demonstrated the combination therapy nearly doubles survival time from 1.5 years to over 2.5 years compared to standard chemotherapy for metastatic bladder cancer.
  • Approximately 1,250 patients annually in England will be eligible for this treatment, which also showed superior response rates with 30% achieving undetectable cancer levels versus 12.5% with chemotherapy.
  • The dual-mechanism approach targets cancer cells directly while simultaneously boosting immune system recognition, offering patients better outcomes with fewer side effects.

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

NCT04223856Active, Not RecruitingPhase 3
Astellas Pharma Global Development, Inc.
Posted 3/30/2020

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

NCT03924895Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 7/24/2019

India Advances Rare Disease Treatment Pipeline with Nine New Medications

Drug Approval
  • India has successfully launched five medications for seven rare diseases including Thalassemia, Wilson's disease, and Cystic Fibrosis, with four additional drugs expected to reach market soon.
  • The National Policy for Rare Diseases currently covers 63 rare conditions, with NITI Aayog prioritizing 13 disorders for accelerated development in 2023.
  • Generic medications from local companies are providing significant cost savings for rare disease patients, while the government's PLI scheme supports production of treatments for eight rare diseases.
  • With 70-90 million Indians affected by rare diseases out of 300 million globally, industry leaders emphasize the need for improved R&D ecosystems and faster regulatory processes.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.