Search Results for “immune” – Page 34 – media

The Results of Phase II Clinical Study of KN046 Plus Chemotherapy as First-line Treatment for Metastatic NSCLC were Published in Cell Reports Medicine

SUZHOU, China, March 22, 2024 /PRNewswire/ — Alphamab Oncology (stock code: 9966.HK) announced that the phase II clinical research results of anti- PD-L1/CTLA-4 bispecific antibody KN046 plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer (NSCLC) were published online in the renowned journal Cell Reports Medicine (IF: 14.3). Professor Li Zhang from Sun Yat-Sen University Cancer Center is the corresponding author of this paper, and Professor Yuanyuan Zhao is the first author. Lung cancer is one of the most common cancers in the world, and it is the malignant tumor with the highest morbidity and mortality in China. According to the latest national cancer statistics released by the National Cancer Center, there are 1.06 million new cases of lung cancer, with a total death toll of 0.73 million in year 2022, far exceeding other tumor types. NSCLC accounts for about 80% – 90% of all lung cancers, and ...
- Source: drugdu
- 131
- March 26, 2024
Four international teams awarded £4.7m to investigate heart and circulatory diseases

These types of conditions are responsible for 25% of all UK deaths and affect 7.6 million people nationally The British Heart Foundation (BHF), the Dutch Heart Foundation and the German Centre for Cardiovascular Research have awarded four international research teams £4.7m for research in heart and circulatory diseases. Over four years, researchers from the UK, Germany and the Netherlands will drive breakthroughs in the detection, diagnosis and treatment of these conditions. Responsible for 25% of all deaths in the UK, heart and circulatory diseases affect around 7.6 million people nationally. Researchers from the University of Bristol, Maastricht University Medical Center, the University of Birmingham, Charité-Universitätsmedizin Berlin, Amsterdam University Medical Center (Amsterdam UMC), the University of Cambridge, Universiteit Leiden, King’s College London (KCL) and University Medical Center Goettingen (UMC Goettingen) have been selected to be funded through the International Cardiovascular Research Partnership Awards. The projects will investigate different areas, including the ...
- Source: drugdu
- 107
- March 26, 2024
FDA Fast Tracks ImmVira’s Oncolytic Herpes Simplex Virus Therapy for Head and Neck Squamous Cell Cancer

Davy James MVR-T3011 IT is in development to treat patients with recurrent or metastatic head and neck squamous cell cancer whose disease progressed following platinum-based chemotherapy and at least one prior line of a PD-1/PD-L1 therapy. ImmVira’s oncolytic herpes simplex virus (oHSV) therapy MVR-T3011 IT for intratumoral injection has been granted Fast Track designation by the FDA to treat patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC) whose disease progressed following platinum-based chemotherapy and at least one prior line of an anti–programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy.1 The novel oHSV treatment is a genetically engineered virus developed to produce replication potency in tumor cells as well as highly restricted replication in normal cells. The ability of MVR-T3011 to boost the immune response within the tumor microenvironment is increased by adding a PD-1 antibody and IL-12 into the construct, according to ImmVira. “Attaining ...
- Source: drugdu
- 85
- March 25, 2024
Precision Medicine Startup Mirador Unveils $400M for R&D of New I&I Drugs

Mirador Therapeutics applies machine learning to human data to discover new immunology and inflammation drugs. The startup’s management includes several from the executive team of Prometheus Biosciences, an immunology biotech bought by Merck last year. By FRANK VINLUAN Nearly a year ago, Merck struck a $10.8 billion deal to acquire Prometheus Biosciences, a clinical-stage company whose technology platform analyzed genetics and biology data to discover new drugs. The executive who led Prometheus to that buyout is now back with a new immunology startup supported by $400 million. Mirador Therapeutics launched Thursday, aiming to take the precision medicine approaches that have led to advances in cancer drugs and apply them to the research of new therapies for immunology and inflammation. It’s a similar strategy to the one taken by Prometheus under the helm of Mark McKenna, now the CEO of San Diego-based Mirador. There’s a plethora of immunology drugs on the ...
- Source: drugdu
- 117
- March 25, 2024
Everest Medicines Announces Singapore Health Sciences Authority Approves NEFEGAN® for the Treatment of Primary IgA Nephropathy in Adult Patients

Shanghai, China – March. 20, 2024 — Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”), a biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the Singapore Health Sciences Authority (HSA) has approved NEFEGAN® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. NEFEGAN®, known in other Everest territories as Nefecon®, was the first ever treatment for IgAN fully approved by the U.S. Food and Drug Administration, and Singapore marks the third region in Everest territories that received New Drug Application (NDA) approval after Macao and mainland China. “The NDA approval in Singapore marks an important event for IgAN patients in the region as we continue to expand patient access to Nefecon® throughout Asia, an area of high IgAN disease prevalence,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Following approval of ...
- Source: drugdu
- 94
- March 22, 2024
FDA Approves First Gene Therapy for Children with Metachromatic Leukodystroph

Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system. It is caused by a deficiency of an enzyme called arylsulfatase A (ARSA), leading to a buildup of sulfatides (fatty substances) in the cells. This buildup causes damage to the central and peripheral nervous system, manifesting with loss of motor and cognitive function and early death. It is estimated that MLD affects one in every 40,000 individuals in the United States. There is no cure for MLD, and treatment typically focuses on supportive care and symptom management. “This is the first FDA-approved treatment option for children who have this rare genetic disease,” said Peter Marks, M.D., Ph.D., director of ...
- Source: drugdu
- 151
- March 20, 2024
BeiGene’s Tevimbra receives FDA approval to treat advanced oesophageal cancer

BeiGene’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) has been approved by the US Food and Drug Administration (FDA) to treat advanced oesophageal squamous cell carcinoma (ESCC). The authorisation specifically applies to adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Oesophageal cancer is the sixth most common cause of cancer-related deaths globally and ESCC accounts for almost 90% of cases. More than two-thirds of patients with oesophageal cancer have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases. BeiGene’s Tevimbra, which is already approved in the EU for advanced or metastatic ESCC after prior chemotherapy, is designed to aid the body’s immune cells to detect and fight tumours. The FDA’s decision on the therapy was based on positive results from the late-stage RATIONALE 302 trial, which compared its ...
- Source: drugdu
- 125
- March 20, 2024
NIHR reveals phase 1/2 trial to evaluate an investigational vaccine for mpox in the UK

More than 3,700 cases of mpox have been identified in the UK since May 2022 The National Institute for Health and Care Research (NIHR) has announced a new phase 1/2 trial, delivered by the NIHR Clinical Research Network and sponsored by Moderna, to test the effectiveness of an investigational mRNA vaccine for mpox. The mPower trial will evaluate the safety and immune response to mRNA-1769, which aims to protect against illness caused by the mpox virus. Currently a global public health threat, mpox is an infectious disease caused by the monkeypox virus, which is spread through physical contact with someone who is infected, leading to symptoms including painful rashes, enlarged lymph nodes and fever. Since May 2022, over 3,700 cases of mpox have been identified in the UK, the majority of which have been from the Clade II B.1 lineage, predominantly in gay, bisexual and other men who have sex ...
- Source: drugdu
- 148
- March 19, 2024
ImmVira’s oncolytic product MVR-T3011 IT Intratumoral Injection Receives FDA Fast Track Designation for HNSCC Treatment

SHENZHEN, China, March 15, 2024 /PRNewswire/ — ImmVira has recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for oncolytic virus product MVR-T3011 IT (intratumoral injection) for the treatment of recurrent or metastatic head and neck squamous cell cancer with disease progression after platinum-based chemotherapy and at least one prior line of anti-PD1/PDL1 therapy. Fast track designation is intended to facilitate the development and expedite the review of drugs targeting serious conditions with unmet medical needs. The Fast Track designation was sought based on the promising potential of MVR-T3011 IT to meet the unmet medical needs associated with HNSCC. Supporting evidence for this request was derived from Phase I/II trials conducted in both the United States and China, focusing on evaluating the efficacy, safety, and durability of response in patients with HNSCC. HNSCC has become a growing public health concern, with increases in incidence ...
- Source: drugdu
- 91
- March 19, 2024
Henlius Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway Steering Group for Serplulimab in ES-SCLC

Recently, an Innovation Passport designation has been awarded to serplulimab, Henlius’ self-developed anti-PD-1 mAb (trade name in China: HANSIZHUANG), for the treatment of extensive stage small cell lung cancer (ES-SCLC) by the U.K. Innovative Licensing and Access Pathway Steering Group including the Medicines & Healthcare products Regulatory Agency (MHRA). This designation marks serplulimab’s entry into the U.K.’s Innovative Licensing and Access Pathway (ILAP) and is expected to promote the presence of serplulimab in the U.K., benefiting more local SCLC patients. ILAP steering group consists of The All Wales Therapeutics and Toxicology Centre (AWTTC), The Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC). It was launched by the MHRA in order to accelerate the development and access to promising medicines. The designation is open to medicinal product that developed for life-threatening or seriously debilitating condition and meet ...
- Source: drugdu
- 109
- March 18, 2024

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