Search Results for “immune” – Page 61 – media

With Iveric Bio buyout, Astellas CEO Naoki Okamura acted on the company’s mantra to be ‘aggressive’

Earlier this year, when Astellas announced that Naoki Okamura was taking over as CEO, the Japanese company said that 2023 was the right time for it to “go on the aggressive to further stimulate growth.”It took Okamura less than a month into his tenure—which began April 1—to act on the company’s game plan. On April 29, he struck the largest acquisition in Astellas’ history, a $5.9 billion buyout of Iveric Bio. With the New Jersey-based biotech two months away from an FDA decision on its geographic atrophy (GA) eye disease candidate Zimura, Astellas hopes to become a major player in a new arena. “We had been closely watching the lead program for Iveric for a very long time, probably seven, eight years,” Okamura said in an interview with Fierce Pharma. “Because the modality of that project is very new to us, we were kind of hesitant to do any partnerships ...
- Source: drugdu
- 114
- June 15, 2023
Updated Covid vaccines need to target XBB omicron variants this fall, FDA staff says

U.S. Food and Drug Administration staff on Monday said updated Covid boosters should target XBB omicron subvariants for the upcoming fall and winter vaccination campaign. The U.S. should use a monovalent vaccine targeting either XBB.1.5, XBB.1.16, or XBB.2.3, collectively the dominant strains nationwide, the staff said in a briefing document. The FDA staff made the conclusion ahead of a meeting on Thursday, when a panel of external advisors to the agency will recommend a strain for new Covid shots to target later this year. There is no set date for when the vaccination campaign will begin. Vaccine manufacturers will be expected to update their shots once that strain is selected. Pfizer, Moderna and Novavax are already developing versions of their respective vaccines targeting XBB.1.5 and other circulating variants. The upcoming strain selection will be crucial to those companies’ abilities to compete in the fall, when the U.S. is expected to ...
- Source: drugdu
- 102
- June 14, 2023
Similar symptoms, biological abnormalities underlie long COVID and chronic fatigue syndrome

Long COVID and myalgic encephalomyelitis/chronic fatigue syndrome are debilitating conditions with similar symptoms. Neither condition has diagnostic tests or treatments approved by the Food and Drug Administration (FDA) and each cost the United States billions of dollars each year in direct medical expenses and lost productivity. Doctors and researchers have wondered what are the underlying biological abnormalities that may cause symptoms, and whether these abnormalities are similar in the two illnesses. A review article authored by senior investigators at Brigham and Women’s Hospital and Harvard Medical School, and the Mailman School of Public Health and Vagelos College of Physicians and Surgeons of Columbia University, addresses these questions. In it, the authors review 559 scientific publications. The authors compared the symptoms of both conditions, noting their great similarity, and then showed that very similar underlying biological abnormalities have been found in both conditions, abnormalities involving the brain, immune system, heart, lungs, ...
- Source: drugdu
- 126
- June 13, 2023
Researchers uncover new insights into why individuals are affected differently by COVID-19 infection

A team of researchers at NYU Abu Dhabi, led by Associate Professor of Biology Youssef Idaghdour and working in collaboration with clinicians at several Abu Dhabi hospitals, investigated the association between microRNAs, a class of small RNA molecules that regulate genes, and COVID-19 severity among 259 unvaccinated COVID-19 patients living in Abu Dhabi. The team identified microRNAs that are associated with a weakened immune response and admission to ICU. During this process, they created the first genomic picture of the architecture of blood microRNAs in unvaccinated COVID-19 patients from the Middle East, North Africa, and South Asia regions whose populations are consistently underrepresented in genomics research. The researchers identified changes in microRNAs at the early stages of infection that are associated with specific blood traits and immune cell death, allowing the virus to evade the immune system and proliferate. The results of the system’s genetics study demonstrate that a patient’s ...
- Source: drugdu
- 108
- June 13, 2023
Astellas Submits New Drug Application for Zolbetuximab in Japan

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers TOKYO, June 9, 2023 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan’s Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Japan for these patients. “Gastric cancer remains the third deadliest cancer in Japan, leading to approximately 50,000 deaths per year despite significant strides to reduce the impact of this cancer,” said Pranob Bhattacharya, DrPH, MS, MBA, Executive Director and Interim Head of Immuno-Oncology Development, Astellas. “Astellas’ submission ...
- Source: drugdu
- 125
- June 12, 2023
China Approves the World’s First Vaccine against XBB Descendent Lineages of SARS-CoV-2 for Emergency Use

CHENGDU, China, June 8, 2023 /PRNewswire/ — On June 8th, 2023, Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 cell) developed by WestVac Biopharma/ West China Medical Center, Sichuan University was approved for EUA by relevant authorities in China. This is the first COVID-19 vaccine in the world approved for EUA against XBB descendent lineages of SARS-CoV-2. It demonstrates that China is leading the world in the development of COVID-19 vaccines. WestVac Biopharma and its subsidiary company WestVac Biopharma (Guangzhou) leveraged the rapid response of the insect cell expression platform on constructing the vector for Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 Cell), which is of high purity and high quality for human use. The subunit vaccine antigen is precisely designed based on the structure of the targeting S-RBD and HR proteins of the COVID-19 subvariants XBB.1.5 and BA.5 and self-assembled into stable trimeric protein particles with ...
- Source: drugdu
- 152
- June 12, 2023
Study may help advance data on oncolytic adenovirus mediated double suicide-gene therapy for high-grade brain tumors

Researchers in the Hermelin Brain Tumor Center at Henry Ford Health are leading a Phase I clinical trial studying the maximum tolerated dose of an oncolytic adenovirus, a mutated virus engineered to selectively replicate in and destroy cancer tissue, in combination with fractionated stereotactic radiosurgery among patients who are undergoing resection of a recurrent high-grade astrocytoma brain tumor. Tobias Walbert (M.D., Ph.D., principal investigator of the study and co-director of the Hermelin Brain Tumor Center at Henry Ford Health) said, “The participants in this study have progressive high-grade astrocytoma as well as glioblastoma, and are scheduled to undergo repeat surgery. After the removal of as much tumor tissue as possible, a modified oncolytic adenovirus is injected into the wall of the resection cavity and any residual tumor tissue. The goal of this study is to determine the maximum tolerated dose of the injected adenovirus, which is engineered to selectively replicate ...
- Source: drugdu
- 108
- June 10, 2023
New study shows certain blood pressure drugs could boost the efficacy of cancer immunotherapy

A Ludwig Cancer Research study has shown that some molecules previously used to treat hypertension might also help the immune system to better target cancer cells. Reported in the current issue of Nature, these findings could, in time, be applied to significantly improve the effectiveness and applicability of cancer immunotherapy. “Immunotherapy today can effectively fight only 30% to 40% of cancers,” said Benoît Van den Eynde, who is a member of the Ludwig Institute for Cancer Research, co-director of the de Duve Institute and professor of Tumor Immunology at the University of Oxford. “Many cancers are resistant, largely because their T lymphocytes are not reactive enough. We discovered that drugs once used to treat hypertension could have a very interesting effect in combating these forms of immunotherapy-resistant cancers.” The immune system protects against disease by destroying foreign substances and pathogens, such as bacteria and viruses. T lymphocytes, a type of ...
- Source: drugdu
- 148
- June 9, 2023
Study

The expected course of a patient’s cancer prognosis has traditionally been judged by its type, stage and microscopic aggressiveness, but patients with the same presentation can still have widely divergent outcomes. Researchers from Vanderbilt-Ingram Cancer Center have discovered that differences in tumor mutation burden are a major reason for this divergence. The study, published in JCO Precision Oncology, has revealed that mutation burden is a fundamental predictor of survival, independent of the clinical presentation metrics currently used. The researchers state in the study that mutational indices can be “used to predict disease course as effectively as (cancer) stage or grade.” William Dupont (Study Corresponding Author and Professor, Biostatistics, Health Policy, and Preventive Medicine, Vanderbilt University Medical Center) said, “A major insight of the study was the observation that survival was better at both low and high extremes of tumor mutation burden.” The study investigated the Pan-Cancer Atlas of 10,652 patents ...
- Source: drugdu
- 126
- June 9, 2023
Study

Reviewed by Lily Ramsey, LLMJun 7 2023 The expected course of a patient’s cancer prognosis has traditionally been judged by its type, stage and microscopic aggressiveness, but patients with the same presentation can still have widely divergent outcomes. Researchers from Vanderbilt-Ingram Cancer Center have discovered that differences in tumor mutation burden are a major reason for this divergence. The study, published in JCO Precision Oncology, has revealed that mutation burden is a fundamental predictor of survival, independent of the clinical presentation metrics currently used. The researchers state in the study that mutational indices can be “used to predict disease course as effectively as (cancer) stage or grade.” A major insight of the study was the observation that survival was better at both low and high extremes of tumor mutation burden.” William Dupont, Study Corresponding Author and Professor, Biostatistics, Health Policy, and Preventive Medicine, Vanderbilt University Medical Center The study investigated ...
- Source: drugdu
- 128
- June 8, 2023

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