Search Results for “antibody” – Page 61 – media

GSK, Vir look beyond COVID-19 to develop new therapies for flu and other respiratory viruses

GlaxoSmithKline (GSK) and Vir Biotechnology have expanded their existing COVID-19 collaboration to include a new research and development agreement, focused on therapies for influenza and other respiratory viruses. The expanded collaboration will give GSK exclusive rights to collaborate with Vir on the development of monoclonal antibodies (mAbs) for the prevention or treatment of influenza. That includes an investigational mAb – VIR-2482 – designed as a universal prophylactic for influenza A, which has completed a Phase I trial. The agreement will also includes next-generation antibodies for the prevention or treatment of influenza during a three-year research period. While GSK will have the exclusive option to co-develop VIR-2482, following Vir’s completion and report of the Phase II trial outcomes, the company will share development costs for all other influenza mAbs. The companies will also conduct two additional research programmes as part of the expanded agreement. The first of these is an expansion ...
- Source: drugdu
- 330
- February 22, 2021
Covid-19
Roche’s faricimab hits primary endpoint in wet AMD studies

Roche’s investigational bispecific antibody faricimab has hit the primary endpoint in two Phase III studies in people living with neovascular or wet age-related macular degeneration (nAMD). In the identically designed studies – TENAYA and LUCERNE – faricimab, administered via injections at fixed intervals, met the primary endpoint, showing that people receiving the treatment achieved visual acuity outcomes that were non-inferior to those receiving Regeneron’s Eylea (aflibercept) injections every eight weeks. Within both studies, nearly half (45%) of participants were treated with faricimab every 16 weeks during the first year. “These results show the potential of faricimab as a new class of medicine that could extend time between treatments for people living with neovascular age-related macular degeneration,” said Levi Garraway, chief medical officer and head of Global Product Development, Roche. “We have now seen positive and consistent results in four Phase III studies for faricimab across both neovascular age-related macular degeneration ...
- Source: drugdu
- 279
- January 31, 2021
Roche
Ridgeback Biotherapeutics’ Ebola treatment scores FDA approval

Ridgeback Biotherapeutics’ Ebanga has been approved by the US Food and Drug Administration (FDA) for the treatment of Ebola in adult and paediatric patients. Ebanga (ansuvimab-zykl), formerly mAb114, is a monoclonal antibody isolated from a human survivor of the 1995 Ebola outbreak in Kikwit in the Democratic Republic of Congo (DRC). The development of the treatment has been funded in whole or in part with funds from the US Department of Health and Human Services, as well as the Office of the Assistant Secretary for Preparedness and Response and the Biomedical Advanced Research and Development Authority. The PALM study conclusively demonstrated Ebanga’s safety and efficacy in a randomised controlled trial conducted during the second largest and longest Ebola outbreak in DRC history. “The devoted Ridgeback team embarked on this mission with one goal in mind – to stop the spread of Ebola and stop the devastation created by this aggressive ...
- Source: drugdu
- 248
- December 24, 2020
Ridgeback Biotherapeutics
Janssen eyes US approval for EGFR-targeting NSCLC therapy

4th December 2020 Janssen has submitted an application the US Food and Drug Administration (FDA) seeking approval for its non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 mutations therapy amivantamab. Amivantamab is a bispecific antibody designed to target EGFR and mesenchymal epithelial transition factor (MET) mutated tumours. The FDA submission is based on results from the monotherapy arm of Janssen’s phase I CHRYSALIS study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib, a third generation EGFR tyrosine kinase inhibitor (TKI). An overall response rate (ORR) of 36% was observed in all NSCLC patients and 41% in patients with previously treated with platinum-based chemotherapy. In addition, the median duration of response for all evaluable patients was ten months and seven months for patients previously treated with platinum-based chemoterhapy. The median progression-free survival was 8.3 months for all patients and ...
- Source: drugdu
- 221
- December 11, 2020
NSCLC therapy
Data Byte

A COMPARISON OF NEUTRALIZATION TITERS AND PROTECTION DATA ACROSS CANDIDATES AND AGE GROUPS BY SELINA KOCH, EXECUTIVE EDITOR NOV 20, 2020 | 10:34 AM CST UPDATED ON NOV 20, 2020 AT 11:03 AM CST A pressing question about COVID-19 vaccines is how well they will perform in the elderly, who are at higher risk for severe disease. Wednesday’s report of strong efficacy in subjects over 65 given Pfizer and BioNTech’s mRNA vaccine could portend good news for several of the next candidates. In early-stage clinical trials, at least four other vaccines produced neutralizing antibody levels in non-elderly adults that were in line with those of BNT162b2 from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX), and for the most part, the vaccines’ titers fell less with age than BNT162b2. Only Ad5-nCoV from CanSino Biologics Inc. (HKEX:6185; Shanghai:688185) produced somewhat lower neutralization titers that fell farther with age than BNT162b2 in a live virus assay. Moderna Inc. ...
- Source: drugdu
- 361
- November 27, 2020
Covid-19 vaccine
China’s Sinovac reports mixed findings in early coronavirus vaccine trials

A man works in a laboratory of Sinovac Biotech in Beijing on Sept. 24. The Chinese company is developing an experimental coronavirus vaccine. (Thomas Peter/Reuters) By Eva Dou November 18, 2020 at 5:09 p.m. GMT+8 Sinovac Biotech, one of China’s coronavirus vaccine front-runners, published mixed findings from its two first clinical trials Tuesday, raising the stakes in Indonesia, which has already declared plans to roll out Sinovac’s vaccine. While the vaccine appeared to be safe in these early clinical trials, the company reported that it generated lower levels of protective antibodies in the bloodstream compared with those arising in recovered coronavirus patients. In comparison, Moderna and Pfizer, which have separate experimental vaccines, had reported antibody levels on par with or higher than those produced in recovered coronavirus patients. These early results put Sinovac on the back foot to prove its vaccine is effective in ongoing Phase 3 trials. “That is a concern,” ...
- Source: drugdu
- 145
- November 19, 2020
Covid-19
Discovery of novel hidden gene in SARS-CoV-2

Understanding the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) – the virus that causes the coronavirus disease 2019 (COVID-19) – is crucial for both vaccine and treatment development. Since the pandemic started in December 2019, many studies have explored the virus’s origins and how it infects humans. This way, scientists and clinicians have an idea of how to combat the infection. A team of researchers from Germany, Taiwan, and the United States has identified and characterized a new hidden gene in SARS-CoV-2 that is also present in Guangxi pangolin coronaviruses – though, curiously, absent in closely related pangolin and bat coronaviruses. What are overlapping genes? The coronavirus pandemic raises urgent questions about the properties that allow viruses in animals to jump to humans. Called zoonosis, these types of diseases have impacted human life for years, including the AH1N1 virus, bovine tuberculosis, glanders, and bubonic plague, among others. To further understand zoonotic diseases, ...
- Source: drugdu
- 286
- November 14, 2020
Covid
Enhertu granted Priority Review in the US for the treatment of HER2-positive metastatic gastric cancer

Only HER2-directed medicine to demonstrate significant improvement in overall survival compared to chemotherapy for previously treated patients in this setting AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer significant advances over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, will be during the first quarter of 2021. There are more than 27,000 new cases of gastric cancer in the US each year, of which approximately one in five are HER2 positive.1,2 For patients with metastatic gastric cancer who progress ...
- Source: drugdu
- 319
- November 4, 2020
gastric cancer
Long non-coding RNA CASC9 promotes gefitinib resistance in NSCLC by epigenetic repression of DUSP1

Abstract Resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), such as gefitinib, has greatly affected clinical outcomes in non-small cell lung cancer (NSCLC) patients. The long noncoding RNAs (lncRNAs) are known to regulate tumorigenesis and cancer progression, but their contributions to NSCLC gefitinib resistance remain poorly understood. In this study, by analyzing the differentially expressed lncRNAs in gefitinib-resistant cells and gefitinib-sensitive cells in the National Institute of Health GEO dataset, we found that lncRNA CASC9 expression was upregulated, and this was also verified in resistant tissues. Gain and loss of function studies showed that CASC9 inhibition restored gefitinib sensitivity both in vitro and in vivo, whereas CASC9 overexpression promoted gefitinib resistance. Mechanistically, CASC9 repressed the tumor suppressor DUSP1 by recruiting histone methyltransferase EZH2, thereby increasing the resistance to gefitinib. Furthermore, ectopic expression of DUSP1 increased gefitinib sensitivity by inactivating the ERK pathway. Our results highlight the essential role ...
- Source: drugdu
- 442
- November 3, 2020
RNA CASC9
Natural COVID-19 Infection Produces Robust T Cell Response and Memory to Fight Future Infections, Finds Study

By HospiMedica International staff writers Posted on 08 Sep 2020 Researchers from the University of Oxford (Oxford, UK) have found that natural infection with COVID-19 produces a robust T cell response, including inducing T cell ‘memory’ to potentially fight future infections. While research has shown that COVID-19 induces a B cell antibody response, it has been less clear whether COVID-19 causes the immune system to make virus-specific T cells too, and whether they are important for recovery from the initial infection, and protection against new infections. While antibodies latch onto and destroy disease-causing agents like viruses and bacteria, T cells latch on to diseased cells within the body, such as tumor cells or virus-infected cells. T-cells also help attract other immune cells to the area. T cells are attracted to tumor or viral protein fragments (called epitopes) displayed on the surface of diseased cells, which act like waving a flag ...
- Source: https://www.hospimedica.com/covid-19/articles/294784403/natural-covid-19-infection-produces-robust-t-cell-response-and-memory-to-fight-future-infections-finds-study.html
- 243
- September 9, 2020

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