Search Results for “Clinical Trial” – Page 89 – media

Man-made antibody successfully prevents organ rejection after transplantation

A man-made antibody successfully prevented organ rejection when tested in primates that had undergone a kidney transplant, Duke Health researchers report. The finding clears the way for the new monoclonal antibody to move forward in human clinical trials. Results of the study appear online Aug. 30 in the journal Science Translational Medicine. Imran J. Anwar, (M.D., lead author, surgical research fellow in Duke’s Department of Surgery) said, “Current medications to prevent organ rejection are good overall, but they have a lot of side effects. These therapies suppress the immune system, putting patients at risk of infections and organ damage, and many cause non-immune complications such as diabetes and high blood pressure. The push over the last 30 to 40 years has been to develop new, less toxic drugs. We are hopeful this antibody moves us closer to that goal.” Anwar and colleagues, including co-senior author Allan Kirk, M.D., Ph.D., chair ...
- Source: drugdu
- 114
- September 1, 2023
New MD Anderson Research Uncovers Drug Combo That Could Eliminate Pancreatic Cancer Tumors

Researchers at the University of Texas MD Anderson Cancer Center published two studies this week on a new approach that could improve treatment for patients with pancreatic cancer — a disease that an estimated 64,050 U.S. adults will be diagnosed with in 2023. The preclinical studies showed that combining immunotherapy with a KRAS inhibitor can lead to long-lasting tumor elimination in pancreatic cancer. The research explored the functional role of KRAS mutations in pancreatic cancer. KRAS belongs to a family of genes that encode proteins that participate in cell signaling, activating or deactivating to regulate the growth of cells. When KRAS are mutated, they cause the uncontrolled cell growth that occurs in cancer. The oncology community has known “for a while now” that KRAS mutations drive pancreatic cancer, but it has had a hard time figuring out a way to effectively drug these mutated genes, explained Dr. Raghu Kalluri, an ...
- Source: drugdu
- 119
- August 29, 2023
Novo Nordisk engages Thermo Fisher to produce weight-loss drug

Novo Nordisk has engaged Thermo Fisher as a contract manufacturer to produce the weight-loss drug, Wegovy (semaglutide), Reuters reported, citing a source with knowledge of the matter. ThermoFisher is carrying out the filling of the Wegovy injection pens at its plant in Greenville, North Carolina, the source added. The publication quoted Novo Nordisk chief financial officer Karsten Munk Knudsen as saying in May 2023 that the company had hired a second contract manufacturer in the US, without revealing its identity. A spokesperson from Novo Nordisk declined to comment on the latest development. The company is currently working on increasing the drug output to meet the rising demand in the US, and due to manufacturing issues at a Catalent-operated plant in Brussels, Belgium. Catalent was engaged by Novo Nordisk as the first contract manufacturer for Wegovy production. In July 2023, the Brussels factory filling self-injection pens for Wegovy violated US sterile-safety ...
- Source: drugdu
- 229
- August 28, 2023
Genethon’s Gene Therapy for Rare Liver Disease Shows Promising Early-Stage Results

By Connor Lynch Pictured: Illustration of a human body with the liver highlighted/iStock, magicmine Genethon’s experimental gene therapy for treating Crigler-Najjar syndrome, a rare liver disease that causes the toxic buildup of bilirubin, showed promising results in a Phase I/II study published Thursday in The New England Journal of Medicine. The clinical trial, sponsored by Genethon, brought together researchers from Italy, the Netherlands, and France to study the efficacy and safety of Genethon’s GNT 0003 candidate gene therapy. The drug combines an AAV8 vector with a copy of gene UGT1A1, which is defective in patients with the condition. The goal of the treatment is to restore function of the liver and restore its ability to produce the UGT1A1 enzyme, which is responsible for breaking down bilirubin. The study examined 17 women aged 21 to 30 years with severe Crigler-Najjar syndrome. According to the results, the drug restored expression of the ...
- Source: drugdu
- 117
- August 22, 2023
【EXPERT Q&A】What is the procedure for registering medical devices for the Russian market?

Drugdu.com expert’s response: The registration process in Russia mainly consists of the following steps: Submission of Application: First, you need to submit a registration application to the Russian Ministry of Health. This typically includes detailed information about your product such as the name, type, specifications, manufacturer information, etc. Technical Documentation Review: The Russian Ministry of Health will review the technical documentation you have submitted. This might encompass details of your product design, production process, quality control systems, etc. Clinical Evaluation: You might be required to undergo a clinical evaluation to demonstrate the safety and efficacy of your product. This could involve clinical trials or submission of other forms of clinical data. Manufacturer Review: The Russian Ministry of Health might review the manufacturer to ensure compliance with Russian laws and regulations. Obtaining the Registration Certificate: If your product passes the above steps of the review, you will receive a registration certificate. ...
- Source: drugdu
- 320
- August 22, 2023
medical device Russia market
Chimerix’s Drug Candidate Improves Survival for Patients with Incurable Brain Tumor

By Matt Olszewski Pictured: Adult holding child’s hand/gorodenkoff/iStock Biopharma company Chimerix announced Wednesday positive results from two early-stage clinical trials for its first in-class small molecule imipridone, a potential treatment for an incurable and aggressive type of pediatric brain tumor which demonstrated longer survival in this subset of patients. The data, published Wednesday in the journal Cancer Discovery, showed that Chimerix’s ONC201 nearly doubled survival for patients with H3K27M-mutated diffuse midline gliomas (DMG), as compared to previous patients. Diffuse midline gliomas with the H3K27M mutation are aggressive, with a survival rate of 11 months to 15 months. However, the median overall survival was nearly 22 months for tumors that had not recurred at the time of enrollment in the trial. In addition, almost a third of those patients lived longer than two years. “These data further elucidate the underlying novel mechanism of action for ONC201 in a patient population which ...
- Source: drugdu
- 114
- August 21, 2023
US study finds potential new way of improving immunotherapy for tumours

A new study by the University of Pittsburgh and the University of Pittsburgh Medical Centre (UPMC) in the US has revealed a new way to stimulate the immune system to enable immunotherapy to shrink or eradicate aggressive tumours. By equipping oncolytic viruses, genetically modified viruses, with tumour-inhibiting genetic cargo, researchers found that it ‘warms up’ cold tumours in the immune system and helps immunotherapy tackle the tumour. Oncolytic viruses were previously designed to directly eliminate cancer cells. Researchers found that oncolytic viruses could stimulate the immune system, suggesting their potential use with other cancer therapies to remove the brakes on the immune system for T cells to recognise and combat tumours. “Immune checkpoint inhibitors work only in ‘hot’ tumours, which have already been infiltrated by T cells,” said Greg Delgoffe, associate professor of immunology at Pitt’s School of Medicine and director of the Tumor Microenvironment Center at UPMC Hillman Cancer ...
- Source: drugdu
- 124
- August 21, 2023
FDA approves Talvey for heavily pre-treated multiple myeloma

US Food and Drug Administration (FDA) has approved Talvey (talquetamab-tgvs) for the treatment of refractory or relapsed multiple myeloma in adult patients who have received at least four prior lines of therapy. Talvey is a bispecific antibody targeting T-cell CD-3 receptors and G protein-coupled receptor class C group 5 member D (GPRC5D) developed by Janssen. It received accelerated approval as a weekly or biweekly subcutaneous therapy. University of California multiple myeloma programme director Ajai Chari noted in a press release: “Patients at this stage of the disease have a poor prognosis. Talquetamab as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer.” The approval was based on meaningful overall response rates (ORR) demonstrated in the Phase II clinical trial data. However, continued approval for Talvey is contingent upon further confirmatory trials showing clinical benefit. To that end, Talvey is only available for use via a ...
- Source: drugdu
- 120
- August 21, 2023
Wegovy could prevent up to 1.5 million heart attacks, strokes over 10 years, study says

Novo Nordisk’s blockbuster weight loss injection Wegovy could prevent up to 1.5 million heart attacks, strokes and other cardiovascular events in the U.S. over 10 years, according to a study released this week. Researchers from the University of California, Irvine, also found that Wegovy could result in 43 million fewer Americans with obesity over a decade. Notably, the study was partly funded by Novo Nordisk. The study results complement the initial data the Danish company released last week from a large clinical trial, which found that Wegovy slashed the risk of serious heart problems and heart-related death by 20%. Novo Nordisk’s trial studied overweight or obese patients with established cardiovascular disease, while UC Irvine’s study examined similar patients, albeit without the disease. Together, the results suggest that Wegovy and, likely, similar obesity drugs have significant health benefits beyond shedding unwanted pounds. Physicians and Wall Street analysts hope that could eventually ...
- Source: drugdu
- 193
- August 18, 2023
NHS England to offer millions of children flu vaccines from September

The NHS has announced that millions of children in England will be offered a flu vaccine as of September 2023 as part of its “life-saving” vaccination programme to protect the country against deadly viruses ahead of winter. School-aged children will receive the flu vaccine either at school or at community clinics, and those who are aged two and three years or have long-term health condition will be offered the vaccine at GP surgeries. The rollout follows the NHS’s winter flu and COVID-19 vaccination programme to provide protection to those eligible from developing serious illnesses and minimise hospitalisations during the winter months. Professor Sir Stephen Powis, NHS England medical director, said: “Vaccinations are our best defence against flu and COVID-19 ahead of what could be a very challenging winter.” By prioritising flu vaccinations for children, the NHS aims to “break the chain of transmission” to the wider population. Earlier this month, ...
- Source: drugdu
- 206
- August 16, 2023

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