Gracell is pioneering use of a CD19/BCMA dual-targeted CAR-T cell therapy in rSLE, aiming for deeper and wider depletion of disease-causing antibody secreting cells and B-cells FasTCAR-T GC012F has demonstrated a favorable safety profile in clinical investigator-initiated trials in 60 patients with multiple myeloma and B-cell non-Hodgkin lymphoma SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 21, 2023 (GLOBE NEWSWIRE) — Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has cleared Gracell’s Investigational New Drug (IND) application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of refractory systemic lupus erythematosus (rSLE). Under the IND, Gracell plans to initiate a Phase 1/2 clinical study in China to further evaluate ...
Atropos Health and Seqster joined forces to address historical diversity and inclusion challenges in clinical trials. The partnership seeks to enable the swift creation of turnkey patient registries that generate real world evidence from existing registries in under 48 hours. By KATIE ADAMS Two healthcare data companies joined forces on Thursday to address historical diversity and inclusion challenges in clinical trials. Atropos Health, a Palo Alto-based company that delivers clinical data to physicians at the point of care, formed a strategic partnership with Seqster, a San Diego-based company that aggregates patient data from various sources. Together, they plan to remove barriers that perpetuate the lack of diversity in clinical trials. The partnership seeks to enable the swift creation of turnkey patient registries that generate real world evidence from existing registries in under 48 hours. These registries encompass real time updates to medical records, patient reported outcomes and tools for querying ...
Shanghai, China, Dec 13th, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first subject was dosed for a phase 1 clinical trial of the company’s independently developed ipilimumab biosimilar HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) in China. Immune checkpoint inhibitors are playing a crucial part in immunotherapy, which has emerged in recent years as a novel approach to combating tumour cells with distinct advantages and enormous promise [1]. In addition to PD-1/L1 and LAG-3, CTLA-4 is also an inhibitory immune checkpoint which expressed on regulatory T cells and activated T cells and has a higher affinity to B7 molecules compared with CD28, thus can competitively bind to B7 molecules to inhibit the proliferation and activation of T cells [2]. Anti-CTLA-4 fully human monoclonal antibody (mAb) can block the inhibitory effects of CTLA-4 on the co-stimulation signal necessary to T cell activation and can increase the number ...
Recently, CanSino Biologics’ adsorbed acellular (component) diphtheria-tetanus combination vaccine (hereinafter referred to as “Tdcp for adolescents and adults”) officially launched Phase I clinical trials and completed the enrollment of the first subject. Tdcp for adolescents and adults is suitable for people aged 6 years and above. It is a booster vaccine for adolescents and adults. This randomized, blinded, controlled phase I clinical trial will initially evaluate the safety and immunogenicity of the vaccine. Whooping cough, diphtheria and tetanus, also known as diphtheria, are serious diseases caused by bacteria. Since the protective effect of immunity triggered by the main antigen of pertussis gradually decreases after vaccination, the incidence and mortality of pertussis gradually increase in the post-vaccination population. The domestic market is in urgent need of a DPT vaccine with longer-lasting immune protection and higher safety. Major developed countries have included this vaccine in their regular vaccination plans, but there is ...
Important Notice: Changchun BCHT Biotechnology Co. (hereinafter referred to as the “Company”) has recently received the Notice of Approval of Drug Clinical Trial from the State Drug Administration. 2, the freeze-dried human rabies vaccine (human diploid cells) subsequent clinical trials are uncertain, and there is a certain degree of uncertainty whether the commercial purpose can ultimately be achieved. Investors are kindly advised to make decisions with caution and pay attention to the prevention of investment risks. The relevant information is announced as follows: I. Main information of the Notice of Approval of Drug Clinical Trial Acceptance No.: CXSL2300615 Notification No.: 2023LP02456 Drug Name: Lyophilized Human Rabies Vaccine (Human Diploid Cells) Conclusion: Agree to carry out clinical trials for the prevention of rabies. Approval date: December 6, 2023 The freeze-dried human rabies vaccine (human diploid cell) approved by the Company this time is freeze-dried human rabies vaccine (MRC-5 cell). II. Introduction ...
Don Tracy, Associate Editor Trial results expected to accelerate the potential of Dupixent to become the first FDA-approved treatment for chronic obstructive pulmonary disease. Regeneron Pharmaceuticals and Sanofi have announced that a Phase 3 trial evaluating Dupixent (dupilumab) in the treatment of chronic obstructive pulmonary disease (COPD) showed the drug reduced exacerbations by 34%, reportedly confirming positive results from its earlier Phase 3 BOREAS trial. According to a Regeneron press release, the NOTUS trial also confirmed that treatment led to rapid and significant improvements in lung function by 12 weeks and were sustained at 52 weeks. Back in May, the companies also announced the success of the aforementioned BOREAS trial for investigational use of Dupixent in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with COPD and evidence of type 2 inflammation. Earlier this year, the drug was granted FDA Breakthrough Therapy designation as an add-on maintenance treatment in ...
Don Tracy, Associate Editor Study aims to find ways industry gets involved in the most influential clinical trials, and how transparent these trials are. In a study published earlier this month by JAMA, the authors aimed to discover how the pharmaceutical industry gets involved in the most influential modern clinical trials and how they fare in terms of transparency. Crediting the major impact of these clinical trials on medical practice, the authors believed that it was important to evaluate the extent of industry involvement and the use of transparency practices in such studies published in the last few years. In order to find a sufficient answer, the study relied on a meta-research assessment consisting of 600 randomized and nonrandomized clinical trials published in 2019 or later. Trials that attracted the highest number of number of citations in Scopus as of December 2022 were selected for analysis, occurring from March to ...
Today, UNITE4TB, an international public-private partnership striving to fast-track the development of innovative Tuberculosis (TB) treatments, announced the start of its phase 2B/C clinical trial program with the first participant enrolled at its trial site in Cape Town, South Africa. The announcement is a major milestone for the project and the TB community as a whole, helping to advance TB science and enhance the efficiency with which new treatments are delivered. The TB challenge TB is a major threat to public health, being among the leading causes of death worldwide. In 2021, the disease claimed the lives of 1.6 million people, making it the second leading infectious killer after COVID-19. Drug-resistant TB and long treatment regimens have increased the urgency for action and investment in TB research. For people affected by TB, the most important outcome is rapid access to better regimens of shorter treatment duration and with fewer side ...
Mike Hollan Gill discusses her continuing work to transform clinical trials and improve the patient experience through DCTs. Harpreet Gill Head of decentralized clinical trials Icon Harpreet Gill, head of decentralized clinical trials (DCTs) at Icon, is working to make DCTs more easily implemented and more commonly used throughout the industry. She recently spoke with Pharmaceutical Executive about her work. Pharmaceutical Executive: Can you explain the importance of decentralized trials? Harpreet Gill: As the time has gone on over the last few years (and we know the pandemic accelerated this) there’s been a greater need to think about the different ways to engage patients in clinical trials. There’s an element of efficiency there in terms of how data is collected. One of the things that we are seeing is that there are more clinical trials, but there aren’t as many patients there are interested in being involved because it can ...
The universal vaccine could protect people against more strains of flu The National Institutes of Health (NIH) has announced that it has begun dosing patients in a phase 1 clinical trial of a new influenza (flu) vaccine candidate, FluMos-v2, to evaluate the vaccine for safety and its ability to elicit an immune response. Designed by researchers at the National Institute of Allergy and Infectious Diseases’s (NIAID) Vaccine Research Center (VRC), FluMos-v2 works to induce antibodies against various influenza strains by displaying part of the influenza virus haemagglutinin (HA) protein in repeating patterns on self-assembling nanoparticle scaffolds, preparing the immune system to recognise and fight the actual virus. Sponsored by NIAID, the trial is expected to enrol 24 healthy individuals, aged 18 to 50 years, to receive two intramuscular injections of the vaccine candidate, 16 weeks apart. The researchers aim to enrol 12 participants in a lower dose group (60mcg per ...
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