Clinical Trial News
AKANTIOR® Receives UK Marketing Authorization as First Approved Treatment for Acanthamoeba Keratitis
- SIFI's AKANTIOR® (polihexanide 0.08%) has received both Marketing Authorization and Promising Innovative Medicine designation from the UK's MHRA, marking it as the first approved treatment for Acanthamoeba keratitis.
- The approval confirms AKANTIOR's Orphan Drug Designation and New Active Substance status, recognizing its efficacy against an ultra-rare corneal infection that can lead to blindness if untreated.
- Following its European approval in August 2024, this UK authorization represents a significant advancement for patients with this devastating eye infection, with SIFI planning to file for NICE reimbursement by June 2025.
FDA Approves 18 New Personalized Medicines in 2024, Marking Significant Shift in Treatment Paradigm
- The FDA approved 18 new personalized medicines in 2024, representing 38% of all newly approved therapeutic molecular entities across multiple treatment areas including cancer and Alzheimer's disease.
- Six new gene and cell-based therapies for rare genetic diseases and cancers were authorized, alongside expanded indications for 11 diagnostic testing systems and the first-ever expanded indication for an approved gene therapy.
- Personalized medicines now constitute at least 25% of drug approvals for the past decade, a substantial increase from less than 10% ten years ago, demonstrating the healthcare system's shift away from one-size-fits-all approaches.
VESALIUS-REAL Study Reveals Critical Gaps in Cardiovascular Care Despite Available Treatments
- The VESALIUS-REAL study of 278,000 high-risk patients found 70% did not receive lipid-lowering therapy after heart attacks or strokes, and 88% had no treatment intensification within a year.
- Half of cardiovascular event patients never received follow-up LDL-C testing, and among those tested, 82% failed to achieve guideline-recommended cholesterol goals despite available treatments.
- Amgen is working to address these care gaps through initiatives including free LDL-C testing at CVS MinuteClinics, partnerships with cardiology organizations, and the LATTICE Consortium to accelerate implementation science.
Merck and Daiichi Sankyo Launch Phase 3 Trial of Novel B7-H3 Targeted ADC for Advanced Esophageal Cancer
- The IDeate-Esophageal01 Phase 3 trial has begun evaluating ifinatamab deruxtecan, a potential first-in-class B7-H3 directed antibody-drug conjugate, against standard chemotherapy in advanced esophageal squamous cell carcinoma.
- Esophageal squamous cell carcinoma accounts for 90% of global esophageal cancers with dismal survival rates of 15-20%, highlighting the urgent need for new treatment approaches after first-line therapy failure.
- The trial follows promising early-phase results and will enroll approximately 510 patients across Asia, Europe, and North America, with overall survival as the primary endpoint.
Highlighted Clinical Trials:
Daiichi Sankyo
Posted 3/9/2022
Daiichi Sankyo
Posted 3/27/2025
Daiichi Sankyo
Posted 4/10/2024
Daiichi Sankyo
Posted 5/21/2024
Daiichi Sankyo
Posted 11/3/2019
Cipla Receives VAI Status from USFDA for Two Manufacturing Facilities
- Cipla's Goa API facility and Sitec Labs' Mahape analytical testing facility have both received Voluntary Action Indicated (VAI) status from the USFDA following recent inspections.
- The Goa Medispray facility inspection concluded with one observation in Form 483, while the Mahape facility received two observations during its February 2025 inspection.
- The VAI classifications allow both facilities to continue operations while addressing the minor compliance issues identified by regulators, representing positive regulatory outcomes for the global pharmaceutical company.
New Mainland Chinese Cancer Drug Shows Promising Results in Phase 1 Trial
- A multinational study led by Chinese University of Hong Kong researchers found that D3S-001, a mainland-developed cancer drug, effectively treats tumors driven by KRAS-G12C gene mutations.
- The phase 1 trial demonstrated remarkable efficacy with over 70% of the 42 participating patients experiencing significant tumor shrinkage or complete disappearance after treatment.
- Researchers noted that D3S-001 inhibits the KRAS-G12C mutation more quickly and potentially for longer durations than existing first-generation inhibitors, showing promise for non-small-cell lung, colorectal, and pancreatic cancers.
FDA Rejects ImmunityBio's Expanded Anktiva Application While Lifting Hold on Atara's Ebvallo Trials
- ImmunityBio received an FDA "refusal to file" letter for its application to expand Anktiva's use in bladder cancer patients, causing a 25% stock plunge and prompting calls for agency clarification.
- The rejection comes despite Anktiva's approval last year for a related subset of bladder cancer patients, with ImmunityBio's founder Patrick Soon-Shiong citing "confounding inconsistency" in the FDA's decision-making process.
- In contrast, Atara Biotherapeutics received positive news as the FDA lifted its clinical hold on blood cancer drug Ebvallo and scheduled discussions for resubmission, driving a 6% stock increase.
€13.6M EU-Funded PREDI-LYNCH Project Aims to Transform Cancer Screening for Lynch Syndrome Patients
- The PREDI-LYNCH project has received €13.6 million in EU funding to develop non-invasive liquid biopsy tests for early cancer detection in Lynch Syndrome carriers, addressing a critical unmet medical need.
- Swedish diagnostics company Elypta joins 27 partners across 16 European countries in this six-year initiative (2025-2031), contributing its proprietary glycosaminoglycan-based biomarker technology.
- With only 5% of Europe's estimated 2 million Lynch Syndrome carriers under cancer surveillance, the project aims to create affordable, accessible screening methods for colorectal, endometrial, and urothelial cancers.
Azvudine Shows Comparable Effectiveness to Nirmatrelvir/Ritonavir for COVID-19 Patients with Chronic Liver Disease
- A multicenter retrospective study found that azvudine demonstrated effectiveness comparable to nirmatrelvir/ritonavir in reducing all-cause death and disease progression in COVID-19 patients with pre-existing chronic liver diseases.
- Azvudine showed superior effectiveness specifically for COVID-19 patients with comorbid primary malignant tumors, potentially offering an alternative treatment option for this vulnerable population.
- Both antiviral medications demonstrated acceptable safety profiles, with azvudine showing slightly better liver function outcomes in patients with chronic liver disease, providing important clinical guidance for treatment selection.
Highlighted Clinical Trials:
NCT06349655Completed
The First Affiliated Hospital of Zhengzhou University
Posted 12/5/2023
ImmuPharma Advances P140 Autoimmune Program with Novel Non-Immunosuppressive Mechanism
- ImmuPharma has made significant scientific breakthroughs with its P140 program, confirming a unique non-immunosuppressive mechanism of action for treating autoimmune conditions.
- The company plans to increase P140 dosage up to 20 times higher than previously tested, following FDA guidance and pharmacokinetic studies, potentially enhancing efficacy without steroid-like side effects.
- ImmuPharma is in active discussions with several global commercial partners while also advancing its anti-infective portfolio targeting fungal and bacterial infections.