MedPath

Clinical Trial News

Waters Corporation and BD Announce $17.5 Billion Merger to Create Life Sciences and Diagnostics Leader

  • Waters Corporation and BD announced a definitive agreement to combine BD's Biosciences & Diagnostic Solutions business with Waters in a $17.5 billion Reverse Morris Trust transaction.
  • The combined company will have pro forma 2025 sales of approximately $6.5 billion and adjusted EBITDA of $2.0 billion, doubling Waters' addressable market to $40 billion.
  • The transaction is expected to generate $345 million in annualized EBITDA synergies by 2030, with $200 million in cost synergies by year three and $290 million in revenue synergies by year five.
  • The deal creates a leader in liquid chromatography, mass spectrometry, flow cytometry, and diagnostic solutions, with over 70% of revenue expected to be recurring annually.

Illimis Therapeutics Secures $42M Series B to Advance GAIA Platform for Alzheimer's and Immune Disease Treatments

  • Illimis Therapeutics closed a $42 million Series B funding round with participation from 18 investors to accelerate development of its GAIA platform targeting Alzheimer's disease and immune disorders.
  • The company's lead candidate ILM01 for Alzheimer's treatment is entering preclinical stage in late 2025 with IND submission expected by end of 2027.
  • Illimis has established strategic partnerships with Eli Lilly's Catalyze360-ExploR&D program and secured additional government funding for global dementia research collaboration.

Ascentage Pharma Raises $192M in Oversubscribed Share Placement to Advance Cancer Pipeline

Drug Approval
  • Ascentage Pharma completed a $192.3 million share placement that was oversubscribed by eight times, demonstrating strong investor confidence in the company's cancer-focused pipeline.
  • The proceeds will fund commercialization efforts for approved drugs olverembatinib and lisaftoclax, expand global clinical development, and strengthen operations infrastructure.
  • The company is advancing multiple Phase III trials including POLARIS-2 for olverembatinib in CML and four GLORA studies for lisaftoclax across various hematologic malignancies.
  • Lisaftoclax recently received NMPA approval in China for relapsed/refractory CLL and SLL, while olverembatinib is already approved and covered by China's National Reimbursement Drug List.

Imugene's Azer-cel Achieves 75% Response Rate in Phase 1b Trial for Relapsed DLBCL

CAR-T
  • Imugene's azer-cel, an allogeneic off-the-shelf CAR T therapy, demonstrated a 75% overall response rate with 55% complete response rate in patients with relapsed/refractory diffuse large B-cell lymphoma who had failed multiple prior therapies.
  • The first patient remains cancer-free at 15 months with additional patients showing durable responses at 2, 5, and 11 months, indicating sustained therapeutic benefit in this high-unmet-need population.
  • Based on these positive results and FDA Fast Track Designation, Imugene plans to meet with the FDA in Q4 2025 to discuss pivotal trial design for potential registration.
  • The trial is expanding to include CAR T-naïve patients with other B-cell lymphoma subtypes including primary central nervous system lymphoma and chronic lymphocytic leukemia.

Dose-escalation, Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Patients with R/r NHL and R/r B-cell ALL

NCT03666000RecruitingPhase 1
Imugene Limited
Posted 3/11/2019

CARsgen Secures European Patent Protection for GPC3-Targeted CAR-T Therapy Following Successful Defense at EPO

CAR-T
  • CARsgen Therapeutics successfully defended its European patent EP3445407 covering GPC3-targeted CAR-T cell therapy after the sole remaining appellant withdrew its challenge on July 3, 2025.
  • The patent protects key claims for GPC3 CAR-T therapy with cyclophosphamide and fludarabine pretreatment across multiple solid tumor types including liver, lung, ovarian, breast, gastric, and thyroid cancers.
  • The EPO Opposition Division's decision to maintain the patent in amended form is now final and binding, preventing any future challenges to the intellectual property.
  • This outcome strengthens CARsgen's competitive position in the emerging field of CAR-T therapies for solid tumors, an area with significant unmet medical needs.

UK and Vietnam Strike £250 Million Pharmaceutical Trade Deal to Accelerate Medicine Registration

  • Britain and Vietnam have agreed to a pharmaceutical trade deal that will streamline medicine registration processes and recognize UK regulatory approvals in the Southeast Asian market.
  • The agreement is projected to generate £250 million in value for the British pharmaceutical sector over the next five years through reduced trade barriers.
  • Vietnam will expedite registration of new medicines and vaccines while recognizing approvals from Britain's Medicines and Healthcare products Regulatory Agency among other regulators.
  • The deal represents part of Britain's new nimbler trade strategy focusing on quick, industry-specific agreements rather than comprehensive free trade deals following Brexit.

Genomill Health's Bridge Capture Technology Matches Gold Standard Sensitivity for Liquid Biopsy in Metastatic Colorectal Cancer

  • Genomill Health's Bridge Capture technology demonstrated high sensitivity matching droplet digital PCR (ddPCR) gold standard for detecting mutations in cell-free DNA from metastatic colorectal cancer patients.
  • The pilot study published in Scientific Reports showed high concordance with established methods while revealing previously unknown oncogenic mutations reflecting disease progression.
  • Bridge Capture offers unlimited panel scalability with simple, cost-efficient workflow that could enable decentralized NGS testing and expand liquid biopsy use in treatment monitoring.

Singapore-Developed Cancer Drug PRL3-zumab Shows Promise for Treating Vision Loss in AMD and Diabetic Retinopathy

Monoclonal Antibody
  • A locally developed cancer drug PRL3-zumab will be tested intravenously in Singapore patients with wet age-related macular degeneration and diabetic retinopathy, offering a potential alternative to painful eye injections.
  • Pre-clinical studies published in Nature Communications showed the drug achieved 86% greater reduction in abnormal blood vessel leakage compared to current eye injection treatments.
  • The drug has demonstrated a good safety profile in 210 advanced cancer patients across Phase II trials in Singapore, the US, China, and Malaysia.
  • Singapore's Health Sciences Authority approved the human trial on June 16, with the 15-patient safety study expected to begin by late 2025.

Pfizer Receives CDSCO Approval for Phase III RSV Vaccine Trial in India with Conditional Requirements

  • Pfizer's Respiratory Syncytial Virus Prefusion F Subunit Vaccine (RSVPref) received approval from India's CDSCO expert panel to conduct Phase III clinical trials following a June 24, 2025 review meeting.
  • The vaccine is already approved in multiple countries including the USA, Europe, Japan, Canada, Brazil, and Thailand for preventing lower respiratory tract disease caused by RSV.
  • The approval comes with a specific condition requiring Pfizer to clarify the number of subjects with preexisting stable disease in their trial protocol.
  • RSVPref is designed for use in adults aged 60 years and older, as well as for maternal immunization to protect infants from birth through six months of age.

Cipla Plans Entry into India's Weight Management Market as Obesity Becomes Strategic Priority

  • Cipla is preparing to enter India's weight management segment to address rising demand for effective obesity solutions, as announced by CEO Umang Vohra in the company's 2024-25 annual report.
  • The Mumbai-based pharmaceutical company is strengthening its central nervous system portfolio through strategic in-licensing deals, including Sanofi's CNS product range featuring Frisium for epilepsy treatment.
  • Cipla aims to pursue additional acquisitions in ADHD and Parkinson's disease while developing four novel antimicrobial resistance products as part of its innovation-led strategy.
  • The company reported consolidated revenue of Rs 27,548 crore and net profit of Rs 5,272 crore in FY25, positioning itself as a global, patient-centric healthcare leader.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.