Clinical Trial News
FDA Adds Heart Inflammation Warning to Moderna and Pfizer COVID-19 Vaccine Fact Sheets
• The FDA has added warnings about myocarditis and pericarditis risks to Moderna and Pfizer-BioNTech COVID-19 vaccine fact sheets following reports of heart inflammation, particularly after second doses.
• CDC has received approximately 1,200 reports of heart inflammation after 300 million vaccine doses, confirming about 300 cases primarily among young men and adolescents, though patients are generally recovering quickly.
• Despite the warning, the CDC's Advisory Committee on Immunization Practices concluded that the benefits of mRNA COVID-19 vaccination continue to outweigh the risks for all populations.
Rapt Therapeutics' RPT193 Faces Setback in Atopic Dermatitis Development
• RAPT Therapeutics' RPT193 saw its Phase Transition Success Rate (PTSR) for atopic dermatitis decrease by 13 points to 78%, despite positive Phase Ib trial results.
• The Phase Ib trial data showed a 36.3% improvement from baseline in Eczema Area and Severity Index (EASI) score with RPT193, compared to 17% with placebo over four weeks.
• RPT193's Likelihood of Approval (LoA) also experienced a slight decrease of one point, settling at 3%, based on GlobalData's analysis.
• Rapt Therapeutics is planning to advance RPT193 into a Phase IIb trial for atopic dermatitis, with the drug targeting CCR4 on Th2 cells.
Highlighted Clinical Trials:
RAPT Therapeutics, Inc.
Posted 8/12/2019
Advances in CAR-T Cell Therapy for Non-Hodgkin Lymphoma
CAR-T cell therapy has emerged as a promising treatment for Non-Hodgkin Lymphoma (NHL), particularly for patients with chemotherapy-resistant forms of the disease. This article reviews the structure, molecular mechanisms, clinical trial results, and challenges of CAR-T cell-based therapies, focusing on their application in NHL.
Highlighted Clinical Trials:
Shenzhen Second People's Hospital
Posted 5/1/2017
Kite, A Gilead Company
Posted 11/9/2015
University Hospital Heidelberg
Posted 9/7/2018
National Cancer Institute (NCI)
Posted 3/17/2017
Baylor College of Medicine
Posted 11/1/2017
Celgene
Posted 12/20/2017
Baylor College of Medicine
Posted 2/1/2014
Hebei Senlang Biotechnology Inc., Ltd.
Posted 6/1/2016
ImmunoGen, Inc.
Posted 1/1/2012
Immune Cell, Inc.
Posted 3/1/2017
Southwest Hospital, China
Posted 10/1/2016
Kite, A Gilead Company
Posted 4/21/2015
Juno Therapeutics, a Subsidiary of Celgene
Posted 11/29/2018
Uppsala University
Posted 4/1/2014
Novartis Pharmaceuticals
Posted 11/12/2018
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016
Seattle Children's Hospital
Posted 11/3/2017
UNC Lineberger Comprehensive Cancer Center
Posted 6/7/2016
Kite, A Gilead Company
Posted 11/15/2018
Crystal Mackall, MD
Posted 9/1/2017
Kite, A Gilead Company
Posted 6/20/2017
Juno Therapeutics, a Subsidiary of Celgene
Posted 7/27/2018
Chinese PLA General Hospital
Posted 10/1/2014
Juno Therapeutics, a Subsidiary of Celgene
Posted 11/27/2017
UNC Lineberger Comprehensive Cancer Center
Posted 12/12/2018
Baylor College of Medicine
Posted 5/8/2017
National Cancer Institute (NCI)
Posted 3/26/2018
Uppsala University
Posted 9/18/2017
Seattle Children's Hospital
Posted 7/27/2017
NCT04162756Approved for Marketing
Kite, A Gilead Company
Medical College of Wisconsin
Posted 10/16/2017
City of Hope Medical Center
Posted 9/24/2014
Fred Hutchinson Cancer Center
Posted 12/5/2017
UNC Lineberger Comprehensive Cancer Center
Posted 8/26/2016
Philips Launches DEFINE GPS Trial to Evaluate iFR-Guided PCI for Superior Outcomes
• Philips has enrolled the first patient in the DEFINE GPS trial, a global study investigating if iFR measurements co-registered on angiograms improve outcomes in coronary interventions compared to standard angiography alone.
• The landmark study will include up to 3,200 participants across 100 sites worldwide, making it one of the largest studies ever sponsored by Philips to address the 20-30% of patients who experience recurring chest pain after PCI procedures.
• Led by Dr. Allen Jeremias and Dr. Gregg Stone, the trial aims to determine whether identifying and treating residual ischemia through routine iFR assessment can enhance patient survival and potentially change the current standard of care in PCI.
Agios Submits New Drug Application to FDA for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency
Agios Pharmaceuticals has submitted a New Drug Application to the FDA for mitapivat, aiming to treat adults with pyruvate kinase deficiency, a rare genetic disease causing chronic hemolytic anemia. This submission is based on results from pivotal studies, highlighting the potential of mitapivat as a disease-modifying therapy.
AI and Automation Set to Transform Pharmaceutical R&D: Industry Faces Cultural and Technical Hurdles
• Pharmaceutical R&D teams are adopting Computer-Aided Biology (CAB) approaches to tackle increasing complexity in drug development, combining AI and automation to enhance scientific workflows.
• McKinsey reports that digital transformation in pharma advanced more in the first ten months of COVID-19 than in the previous decade, with over 60% of life sciences companies investing heavily in AI initiatives.
• Industry faces dual challenges of technical integration and cultural resistance, with lack of skilled workforce ranked as the top barrier to digital transformation in pharmaceuticals.
3 Experts Resign from FDA Panel Over Alzheimer's Drug Approval
Three experts have resigned from an FDA advisory committee following the controversial approval of Aduhelm, an Alzheimer's drug, against the panel's recommendations. The resignations highlight concerns over the drug's efficacy, approval process, and potential impact on future drug evaluations.
Phase I/IIa Clinical Trial of RH5.1/AS01B Vaccine for Blood-Stage Malaria Shows Promising Safety and Immunogenicity
A first-in-human, open-label, non-randomized, multi-center, dose escalation Phase I/IIa clinical trial evaluated the safety, immunogenicity, and efficacy of the RH5.1/AS01B vaccine against blood-stage malaria. The study involved healthy, malaria-naive adults aged 18 to 45, demonstrating the vaccine's potential to reduce parasite multiplication rate and its safety profile across different doses.
Highlighted Clinical Trials:
University of Oxford
Posted 10/17/2016
Laparoscopic Radical Hysterectomy vs. Open Surgery for Early-Stage Cervical Cancer
A recent study evaluates the oncologic outcomes of laparoscopic radical hysterectomy (LRH) compared to open surgery in early-stage cervical cancer patients with lesions less than 2 cm. The findings suggest that LRH may be associated with a higher risk of recurrence, despite offering benefits such as less intraoperative blood loss and faster recovery. The study highlights the need for further research to determine the most effective surgical approach for these patients.
FDA Approves Aduhelm: First Disease-Modifying Alzheimer's Treatment in Nearly Two Decades
• The FDA granted accelerated approval to Biogen's aducanumab (Aduhelm) as the first disease-modifying Alzheimer's treatment in nearly two decades, despite divided expert opinions on its clinical efficacy.
• Aduhelm, priced at $56,000 annually, works by reducing amyloid plaques in the brain and will require monthly intravenous infusions with comprehensive clinical and MRI monitoring for potential adverse effects.
• As part of the accelerated approval, Biogen must conduct a Phase 4 confirmatory trial, while experts view this approval as a potential catalyst for developing more effective Alzheimer's treatments targeting multiple pathways.
Highlighted Clinical Trials:
Biogen
Posted 12/20/2018
Biogen
Posted 9/15/2015
Biogen
Posted 8/13/2015