News about "clinical trial "

Vaccinex Secures USD 60 Million Financing for Phase IIb Alzheimer's Trial

Vaccinex Secures USD 60 Million Financing for Phase IIb Alzheimer's Trial

Vaccinex Inc has entered into a USD 60 million revenue-sharing agreement with Pepinemab Development Venture (PDV), LP to finance an expanded Phase IIb clinical trial of its anti-SEMA4D antibody, pepinemab, for the treatment of Alzheimer’s disease.

Clinical Trial | 24/12/2025 | By News Bureau

Lupin Secures Positive CHMP Opinion for Ranibizumab Biosimilar

Lupin Secures Positive CHMP Opinion for Ranibizumab Biosimilar

Lupin has received a positive opinion from the CHMP for its ranibizumab biosimilar, supported by comprehensive analytical similarity data and a global Phase III clinical trial involving 600 patients with neovascular Age-related Macular Degeneration (AMD).

Clinical Trial | 18/12/2025 | By News Bureau

EMA Enhances Scientific Advice Process for Medicines Targeting Public Health Threats

EMA Enhances Scientific Advice Process for Medicines Targeting Public Health Threats

Under the new system, medicine developers can receive joint scientific advice from EMA and national clinical and ethics experts. This coordinated approach aligns trial and regulatory requirements early, helping accelerate trial approvals and access to critical medicines.

Clinical Trial | 18/11/2025 | By Dineshwori 207

EMA Recommends EU Approval for Waskyra to Treat Wiskott-Aldrich Syndrome

EMA Recommends EU Approval for Waskyra to Treat Wiskott-Aldrich Syndrome

The EMA has recommended EU marketing authorisation for Waskyra (etuvetidigene autotemcel), a gene therapy for patients aged six months and older with Wiskott-Aldrich Syndrome (WAS). The treatment uses a patient’s own modified stem cells to restore functional WAS protein.

Clinical Trial | 17/11/2025 | By Dineshwori 106

VarmX and CSL Sign Deal Worth up to USD 2.2 Billion

VarmX and CSL Sign Deal Worth up to USD 2.2 Billion

Under the agreement, CSL will fully fund clinical development of VMX-C001 and pay VarmX shareholders USD 117 million upfront for an exclusive option to acquire VarmX, in a transaction worth up to USD 2.2 billion

Clinical Trial | 17/09/2025 | By Dineshwori 112

Advarra Launches AI- and Data-Backed Study Design Solution to Improve Operational Efficiency in Clinical Trials

Advarra Launches AI- and Data-Backed Study Design Solution to Improve Operational Efficiency in Clinical Trials

Study Design solution evaluates a protocol's feasibility by comparing it to similar trials using Braid, Advarra's newly launched data and AI engine. Braid is powered by a uniquely rich set of digitised protocol-related documents and operational data from over 30,000 historical studies conducted by 3,500 sponsors.

Clinical Trial | 17/09/2025 | By Dineshwori 172

Pulnovo Wins Two IDE Approvals for PADN Trials with CMS Coverage

Pulnovo Wins Two IDE Approvals for PADN Trials with CMS Coverage

Following the FDA's BDD designation granted in 2021 for Group- I, II and IV, the newly-obtained IDE approvals for Pulnovo Medical’s PADN with CMS coverage will advance clinical studies targeting Groups-I and II into the IDE stage.

Clinical Trial | 13/09/2025 | By Dineshwori 110

NMPA Clears Zhimeng Biopharma's Drug for Phase-II Epilepsy Trial

NMPA Clears Zhimeng Biopharma's Drug for Phase-II Epilepsy Trial

Zhimeng Biopharma’s drug for Phase II epilepsy trial will be evaluated in a randomized, double-blind, placebo-controlled multinational study to test its efficacy, safety, and tolerability as an adjunct therapy in adults with focal epilepsy.

Clinical Trial | 13/09/2025 | By Dineshwori 102

Otsuka Acquires CAN10 from Cantargia

Otsuka Acquires CAN10 from Cantargia

The deal transfers Cantargia’s CAN10 antibody programme to Otsuka, with Cantargia securing an upfront payment of USD 33 Million.

Clinical Trial | 12/09/2025 | By Dineshwori 159

Sanofi Drug Earns Fast Track Status for Wet AMD in US

Sanofi Drug Earns Fast Track Status for Wet AMD in US

Sanofi is evaluating SAR402663 in a Phase 1/2 trial (NCT06660667) for neovascular AMD. The gene therapy targets abnormal blood vessel growth, reduces retinal damage, and aims to eliminate the need for frequent intravitreal injections.

Clinical Trial | 11/09/2025 | By Dineshwori 120


 

 

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