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Clinical

WAKE FOREST, North Carolina and ADELAIDE, Australia, Sept.

by Chief editor of world-today-news.com September 4, 2024

written by Chief editor of world-today-news.com

GNW-Adhoc: Avance Clinical GlobalReady Site Partnership Network grows rapidly to 2,000 members

04, 2024 (GLOBE NEWSWIRE) — Avance Clinical, the award-winning market-leading contract research organization for biotechnology companies, today announced that 2,000 clinical sites across North America have joined the Avance Clinical GlobalReady Site Partnership Network (partnership-network/). Yvonne Lungershausen, CEO of Avance Clinical, said these 2,000 highly qualified sites further enhance unprecedented efficiency and effectiveness for our biotech clients during their clinical development. Tina Schied, Senior Site Specialist at Avance Clinical in the U.S., said the team has individually vetted these sites for quality, therapeutic area expertise, advanced processes and compliance so our clients can be confident in the quality, rapid startup and patient access that are essential to a successful clinical program. ?Avance Clinical is highly respected by U.S.-based biotechnology companies and now accounts for more than 80% of our clients. A critical factor is that we can accelerate their clinical development in the US, Australia and Asia, from preclinical stages through to Phase III,” said Schied. “This is our GlobalReady ( leveraging our unique, streamlined, cross-regional process. With a global approach, we can ensure efficiency at every step,” she said. “Biotech companies are looking for a partner that can enable a seamless transition with high-quality data that is readily accepted by the FDA and other regulators. Our in-house global regulatory affairs team helps biotech companies confidently navigate regulatory complexities and supports our clients in submitting applications to the FDA, EMA and TGA.” “Avance Clinical is a mid-sized, agile and responsive contract research organization with a proven track record of rapidly advancing high-quality clinical programs. Our global team is focused on accelerating drug development for its biotech clients, from preclinical stages through Phase III.” Avance Clinical is also an accredited cell and gene technology contract research organization, meaning it can conduct clinical operations for preclinical and clinical trials for GMO therapies. A new analysis from market research firm Frost & Sullivan shows that one of the biggest challenges for U.S. biotech companies has been finding the right biotech-focused CRO partner. “More than 60% of U.S. biotech companies ( struggle to find the right CRO partner to accelerate their drug development programs,” said Lungershausen. (Read the report here (). The comprehensive report ( highlights the biotech industry’s increasing preference for working with right-sized CROs that can meet the fast-paced needs of the biotech industry. For more information, please click here: * Learn more about the GlobalReady model here ( * If you would like to find out more about the benefits of conducting your next study with Avance Clinical, contact us ( * Request an application to join the GlobalReady Site Partnership Network ( site-partnership-network/) About Avance Clinical Avance Clinical is the largest Australian, Asian, North American and EU contract research organization (CRO) for high-quality clinical trials with globally accepted data for international biotechnology companies in Australia, New Zealand and the USA. The company’s clients are biotechnology companies completing Phases I to III of their drug development program and requiring rapid, flexible and adaptable solution-focused clinical research services. Frost & Sullivan Awards Avance Clinical, a five-year recipient of the Frost & Sullivan Asia-Pacific CRO Market Leadership Award, has been providing contract research services in the region for more than 26 years. Preclinical to Mid-Late Stage Avance Clinical offers preclinical services ranging from preclinical to Phase III clinical services with its experienced ClinicReady team, benefiting from significant Australian Government incentive rebates of up to 43.5% and rapid regulatory ramp-up processes. With experience in over 120 indications, the CRO can deliver best-in-class results and high-quality, internationally accepted data for FDA and EMA review. Technology Avance Clinical uses cutting-edge technology and gold standard systems across all functional areas to provide its clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners. www.avancecro.com ( Â

September 4, 2024 0 comments

Health

WHO: Corona vaccination has saved the lives of 1.6 million people in Europe

by Chief editor of world-today-news.com August 17, 2024

written by Chief editor of world-today-news.com

Did the vaccination against Corona save lives or was it disproportionately risky given the side effects that occurred in some cases? Researchers from the UN World Health Organization (WHO) have now presented an estimate based on data. According to this, around 1.6 million lives were saved in Europe by the vaccinations between December 2020 and March 2023. Compared to the 2.2 million deaths the virus has claimed on the old continent, this would be a great success for the vaccination.

Margaux Meslé and colleagues from the WHO office in Copenhagen took the data on infections and deaths from the European Serveillance System, broken down into the age groups 25 to 49 years, 50 to 59 years, 60 to 69 years, 70 to 79 years and 80 years and older. They also took data on the observed effectiveness of the vaccination from published studies. They combined both with information on the virus variants circulating in each case. (The wild-type virus circulated until January 2, 2021, the alpha variant between June 3, 2021 and January 6, 2021, the delta variant between July 11 and December 5, 2021. From December 13, 2021 until the end of the study period, variants of the omicron lineage were dominant).

They break down their results in the journal “The Lancet Respiratory Medicine”. They estimate that in countries with high vaccination coverage, the reduction in deaths due to vaccinations was 59 percent. This would correspond to around 1.6 million lives saved. Those who benefited most from this were those over 60, who made up 96 percent of the people saved. Of these, the group of those over 80 had the highest proportion, with a total of 52 percent. The third vaccination dose turned out to be particularly effective. It alone reduced mortality by 51 percent, according to the study authors.

August 17, 2024 0 comments

Health

The world’s first tuberculosis vaccine stored for 3 months at room temperature…”First clinical trial success” : Dong-A Science

by Chief editor of world-today-news.com March 6, 2023

written by Chief editor of world-today-news.com

Scanning electron micrograph of the bacterium MYCOBACTERIUM TUBERCULOSIS that causes tuberculosis. Courtesy of the National Institute of Allergy and Infectious Diseases (NIAID).

The results of phase 1 clinical trials of the world’s first cold-storage tuberculosis vaccine have been released. It has been shown to induce the production of high levels of antibodies and even create T cells, which are immune cells. It was analyzed that the effect would last for 3 months if stored at 37 degrees and up to 24 months if stored at 5 degrees. It is expected to be helpful in responding to tuberculosis, which is the second leading cause of death worldwide.

A research team at the Access to Advanced Health Institute (AAHI), a non-profit biotech research institute in the United States, published the results of the phase 1 clinical trial of the tuberculosis vaccine candidate ‘NCT03722472’ in the international journal ‘Nature Communications’ on the 6th.

A total of 48 participants participated in the phase 1 clinical trial. The research team divided the participants into two groups. Twenty-three received the tuberculosis vaccine after processing so that it could be stored at room temperature, and 22 received the tuberculosis vaccine before treatment. Both groups were vaccinated twice each on day 0 and day 56, the starting date of the experiment.

After vaccination, the immune response was analyzed by taking blood, tear, and nasal samples. Tear and nasal samples were taken at the start of the experiment and at 70 and 224 days after vaccination, and blood samples were taken at days 0, 7, 14, 56, 64, 70, 84 and 224 days after vaccination. collected on

Analysis of the samples showed that both vaccines induced high levels of antibodies and immune cell production. In particular, it was found that the effect of the vaccine treated at room temperature was higher than that of the untreated vaccine. The research team said, “This clinical trial proved that the vaccine is safe and effective,” and “it was also proven that the vaccine stored at room temperature elicits a stronger immune response.”

This study was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The research team expects that this research will facilitate the supply of vaccines to African regions where the ‘cold chain’, a system for distributing vaccines at low temperatures, is not properly equipped. Corey Casper, CEO of AAHI, said, “Equitable access to vaccines has been greatly hindered by the cold chain. This study is an important achievement in addressing this problem.”

In Korea, the NA Vaccine Research Institute is developing a tuberculosis vaccine stored at room temperature. It was selected as the ‘1st Global Vaccine Technology Leading Project Group New Support Target Project’ of the Global Vaccine Technology Leading Project Group newly established by the Ministry of Health and Welfare, and is developing a peptide tuberculosis vaccine that can be stored at room temperature.

March 6, 2023 0 comments

Health

NALIRIFOX Drug Combination Breaks Through in Metastatic Pancreatic Cancer

by Chief editor of world-today-news.com January 23, 2023

written by Chief editor of world-today-news.com

Pancreatic cancer is the eighth tumor with the highest incidence in Spain, but it is one of the tumors with the worst prognosis five years after diagnosis. The lack of improvement in survival and the increase in the incidence of this tumor have made predictions place pancreatic cancer as responsible for the second cause of cancer death in the United States in the year 2030. In Europe, its mortality exceeds and that of breast cancer.

“Only 20% of patients with pancreatic cancer are candidates for surgery, and of these, 80% relapse and end up developing metastases, which is why the majority of pancreatic cancer patients end up reaching this stage. In this context , it is important to find new therapeutic options for these patients that improve survival” affirm at Dra. Teresa Macarulla, Head of the Gastrointestinal and Endocrine Tumors Group at the Vall d’Hebron Institute of Oncology (VHIO) and medical oncologist at the Vall d’Hebron University Hospital who has been part of the scientific committee of this multicenter international trial.

“The results of the NAPOLI-3 study demonstrate that a new drug combination could be a new first-line treatment option for patients with advanced pancreatic cancer.“ adds Dr. Macarulla.

The phase III NAPOLI-3 clinical trial compares the antitumor efficacy and safety of NALIRIFOX, a combination of drugs: liposomal irinotecan (Onivyde) con fluorouracilo (5-FU), leucovorina y oxaliplatino compared to gemcitabina more nab-paclitaxel (Gem+NabP) in the first line setting, or first choice of treatment in patients with metastatic pancreatic cancer.

The phase III clinical trial enrolled 770 patients and the median overall survival was 11.1 months for patients treated with NALIRIFOX versus 9.2 months for those receiving Gem+NabP. Progression-free survival (the time from starting treatment until the tumor grows back) was also significantly improved from 5.6 months to 7.4 months.

“We currently have few treatment options for patients with metastatic pancreatic cancer, so any progress in this regard is welcome news.. Having a new therapeutic option with NALIRIFOX is one more step and motivates us to continue researching new treatments” says Dr. Teresa Macarulla.

January 23, 2023 0 comments

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