Cladribine

BioNxt Solutions Secures Eurasian Patent Approval for Sublingual MS Treatment Technology

18 days ago

• BioNxt Solutions has received acceptance of its first national-level patent filing by the Eurasian Patent Organization, confirming the company's core claims of novelty, inventive step, and industrial applicability. • The patent covers sublingual delivery of anticancer drugs for treating autoimmune neurodegenerative diseases, including BioNxt's lead product BNT23001, a thin-film formulation of Cladribine for multiple sclerosis. • BioNxt is advancing patent protection across multiple jurisdictions including Europe, Australia, Canada, New Zealand, USA, and Japan to support commercialization of its sublingual product pipeline for various autoimmune diseases.

Merck's Enpatoran Shows Promise for Lupus Rash in Phase 2 Trial Despite Mixed Results

3 months ago

• Merck's oral TLR7/8 inhibitor enpatoran demonstrated clinically meaningful reduction in disease activity for patients with cutaneous lupus erythematosus and systemic lupus erythematosus with active lupus rash in the Phase 2 WILLOW study. • The drug met its primary endpoint in Cohort A with up to 91.3% of patients achieving CLASI-50 response at Week 24, though it failed to meet the primary endpoint in the systemic lupus erythematosus cohort (Cohort B). • As a potential first-in-class oral therapy targeting the TLR7/8 pathway, enpatoran could address significant unmet needs for lupus patients, with Merck now in discussions with health authorities regarding a global Phase 3 program.

Merck KGaA in Advanced Talks to Acquire SpringWorks Therapeutics; BridgeBio Secures EU Approval for ATTR Drug

3 months ago

• Merck KGaA confirms advanced acquisition discussions with SpringWorks Therapeutics, though critical conditions remain unmet and no binding agreement has been reached. • BridgeBio Pharma's Beyonttra (acoramidis) receives European Commission approval for transthyretin amyloidosis with cardiomyopathy, triggering a $75 million milestone payment from Bayer. • Biohaven's troriluzole receives FDA priority review for spinocerebellar ataxia, positioning it to potentially become the first approved treatment for this neurodegenerative disorder.

Bionxt Solutions to Evaluate Sublingual Cladribine Formulation for Multiple Sclerosis in Clinical Trial

5 months ago

• Bionxt Solutions plans to initiate a clinical trial in the second half of 2025 to assess its sublingual cladribine formulation, BNT23001, for treating multiple sclerosis. • The trial aims to compare the safety, efficacy, and bioavailability of BNT23001 with the oral formulation Mavenclad in patients with MS. • BNT23001, a sublingual film, offers a potentially more convenient administration route, especially for patients with swallowing difficulties, and may have a faster onset of action. • Bionxt is also pursuing patent protection for its sublingual thin-film formulation in key regions, including Europe, the U.S., and Canada.

CLARION Study: Harmonizing Data Quality in Multiple Sclerosis Registries for Long-Term Safety Monitoring of Cladribine Tablets

7 months ago

• The CLARION study assessed long-term safety of cladribine tablets for multiple sclerosis (MS) using real-world data from multiple registries. • A set of 28 data quality indicators (DQIs) were defined to evaluate representativeness, consistency, accuracy, and completeness of data across registries. • The study demonstrated that systematic evaluation of DQIs allows for harmonization of data quality and consistency across MS registries. • Findings support the fitness of data for safety evaluation and regulatory decision-making regarding cladribine tablets in MS treatment.

Roche's Ocrevus to Match Novartis's Gilenya Pricing in UK MS Market

7 years ago

• Roche announces pricing strategy for Ocrevus in the UK multiple sclerosis market, aligning costs with Novartis's Gilenya at approximately £19,169 per patient annually. • Ocrevus becomes the first approved treatment for primary progressive MS (PPMS), though NICE approval for this indication may face longer review timelines. • The drug has demonstrated strong efficacy in relapsing MS with no direct links to PML, positioning it favorably against competitors like Biogen's Tysabri and Tecfidera.