BioPharma Reporter

SEPTEMBER 15, 2020

Vaxart will start a Phase 1 clinical trial for its oral COVID-19 vaccine candidate, having received Investigational New Drug (IND) clearance.

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Drug Discovery World

SEPTEMBER 18, 2023

Next generation Covid-19 vaccines could have the potential to expand the breadth of coverage against existing and future variants of the virus, extend the duration of protection, and offer better protection in the prevention of illness and transmission over the current state of vaccine technologies.

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Pharmaceutical Technology

SEPTEMBER 7, 2022

Indian company Bharat Biotech International has secured approval from Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for its intranasal Covid-19 vaccine, iNCOVACC (BBV154), for usage in people aged 18 years and older. It is formulated to permit intranasal delivery via nasal drops.

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Pharmaceutical Technology

AUGUST 2, 2022

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Following the demonstration at Samsung, the clinical trial of GreenLight’s Covid-19 booster vaccine is anticipated to commence this year.

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Pharmaceutical Technology

JUNE 24, 2022

Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain.

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Pharmaceutical Technology

APRIL 20, 2023

The face of clinical research is evolving. Rather than bringing patients to sites, study teams are now exploring ways they can bring the trial to patients using a varying combination of direct-to-patient drug shipments, home nursing, video conferencing, and electronic data collection. Drug development had to change.

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Drug Discovery World

MAY 18, 2023

A clinical trial of an experimental universal influenza vaccine developed by researchers at the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center (VRC) has begun enrolling volunteers at Duke University in Durham, North Carolina.

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XTalks

MAY 19, 2023

Clinical trials play a vital role in advancing patient treatment and medical care. This article delves into ten trends and statistics in the world of clinical trials for 2023. Increasing Number of Registered Clinical Trials As of May 17, 2023, there are 452,604 registered clinical trials globally on ClinicalTrials.gov.

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Pharmaceutical Technology

DECEMBER 7, 2022

Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. The trial is designed to analyse the safety and effectiveness of the vaccine.

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XTalks

MAY 24, 2023

Leading health solutions company CVS Health recently disclosed that its clinical trial business will shut down just two years after its initiation in May 2021. The company will gradually wind down its CVS Health Clinical Trial Services unit with full exit by December 31, 2024.

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ACRP blog

JANUARY 3, 2024

Historically, patient recruitment and retention have been pressing issues within the clinical trial space. Eighty-five percent of trials fail to recruit enough patients, while 80% are delayed due to other factors like participant dropouts. Diversity and Equity at the Forefront The U.S.

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Medical Xpress

NOVEMBER 16, 2022

COVID-19 vaccines and drugs were developed at "warp speed" and now experts are concerned about the US Food and Drug Administration's (FDA) inadequate surveillance of clinical trial sites, reports an investigation published by The BMJ today.

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Drug Discovery World

SEPTEMBER 19, 2023

The University of Oxford has revealed that researchers are currently in the advanced stages of preparing for a clinical trial of a Nipah vaccine using the ChAdOx1 vector. There are currently no approved vaccines or treatments for Nipah virus infection. Seasonal outbreaks have occurred annually in Bangladesh since 2001.

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XTalks

FEBRUARY 21, 2024

Black participation in clinical trials, and the underrepresentation of minority groups in general in trials, remains low. It is therefore important to work towards increasing Black participation in clinical trials, which begins with understanding the barriers to participation and taking steps to address them.

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Pharmaceutical Technology

DECEMBER 2, 2022

India’s Central Drugs Standard Control Organisation (CDSCO) has granted approval for Bharat Biotech’s BBV154 vaccine for treating Covid-19. BBV154 is claimed to be the first intra-nasal vaccine for Covid-19 in the world.

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Drug Discovery World

APRIL 15, 2024

Naobios has signed a partnership agreement with Sumagen, a Korean-Canadian biotechnology company developing an HIV-1 vaccine candidate, to manage the manufacturing process during its Phase II clinical trials.

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ACRP blog

MARCH 12, 2024

Global Disruptions, Health Equity, and Data Sharing International clinical trials are essential to evaluating the safety and efficacy of new treatments, but their success can be hampered by a variety of challenges. Additionally, how do you ensure that the vaccine distribution is equitable?

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WCG Clinical

JANUARY 4, 2024

Download report Intelligently Connecting Data and Insight to Navigate the Clinical Research Trends of Tomorrow Advancing health is all about connections. Connecting people, data, insights, and technology for a better, more efficient clinical trial experience. Despite this improvement, disconnects remain.

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XTalks

MAY 4, 2023

As of now, the US Food and Drug Administration (FDA) has not approved any drugs for the treatment of celiac disease. However, there are ongoing clinical trials for celiac disease to investigate potential new treatments. How does Beyond Celiac spread awareness about research and clinical trials for celiac disease?

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pharmaphorum

JANUARY 6, 2023

The UK has formed an partnership with German biotech BioNTech to provide up to 10,000 patients with access to personalised cancer therapies, in another example of the country embracing the mRNA technologies that underpinned COVID-19 vaccines. The post UK partners with BioNTech on clinical trials of mRNA cancer therapies appeared first on.

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ACRP blog

MARCH 23, 2023

Generating evidence by integrating research into patient care Clinical trials are increasingly using longitudinal evidence generation, where repeated measurements are taken over time from the same set of patients. This is leading to changes in expectations of how research sites carry out trials.

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Pfizer

FEBRUARY 16, 2023

who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15.

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STAT News

AUGUST 22, 2022

Pfizer and BioNTech said Monday that they have asked the Food and Drug Administration to authorize a new booster shot targeted at the Omicron BA.4/BA.5 5 strain of the coronavirus that causes Covid-19, the first step in a process that could lead to more effective booster shots. Read the rest…

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Drug Discovery World

MAY 15, 2024

Researchers have developed a new vaccine technology that can provide protection against a broad range of coronaviruses with potential for future disease outbreaks – including ones we don’t know about yet. By training the immune system to attack these regions, it gives protection against other coronaviruses not represented in the vaccine.

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Velocity Clinical Research

JULY 18, 2023

Born and trained in Egypt, he moved to the UK several years ago after working as a general practitioner there and deciding he loved the country and the clinical trial opportunities it offered. Mutiah, originally from India, moved to the UK and became a study coordinator in 2014. By 2018, she was directing seven sites.

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Velocity Clinical Research

APRIL 5, 2024

Velocity recently asked some key employees to come together and discuss a wide array of issues impacting diversity, equity, and inclusion (DEI) in clinical trials. At its core, Velocity’s strategy is to put sites in locations to best advance diversity in clinical trials. appeared first on Velocity Clinical Research.

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Drug Discovery World

APRIL 26, 2024

The leading news story this week has been the launch of a new clinical trial in the UK for a melanoma personalised mRNA cancer vaccine, but there have been a number of other interesting developments in cancer drug discovery. News round-up for 22-26 April by DDW Digital Content Editor Diana Spencer.

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Pharmaceutical Technology

NOVEMBER 24, 2022

South African bio-pharmaceutical firm Biovac and the International Vaccine Institute (IVI) in South Korea have signed a licencing and technology transfer agreement for developing and manufacturing an oral cholera vaccine (OCV).

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Bio Pharma Dive

AUGUST 22, 2023

The funds going to Regeneron, clinical trial partners and other developers are the first major investments under a federal program announced in May.

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Velocity Clinical Research

DECEMBER 27, 2023

Our sites conducted clinical trials that supported 12 U.S. From pioneering vaccines to cutting-edge drugs, Velocity’s team worldwide has worked diligently to support these significant achievements. Velocity has made an incredible impact over the past year! We cannot wait to see what next year brings.

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STAT News

SEPTEMBER 29, 2022

A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. Read the rest…

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Drug Discovery World

APRIL 14, 2023

Clinical trials are, undoubtedly, an essential part of the drug development process, providing us with valuable information about the safety and efficacy of new treatments and therapies. of participants 2 Covid-19 vaccination trials. First, it can lead to delayed approval of drugs for minority populations.

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Pharmaceutical Technology

NOVEMBER 20, 2022

Health Canada has granted expanded authorisation for Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted) [Nuvaxovid; NVX-CoV2373] as a homologous booster for usage in adults aged 18 and above. The vaccine is indicated for active immunisation to prevent the disease.

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Drug Discovery World

FEBRUARY 27, 2024

New studies have demonstrated that Vaxxinity’s vaccine VXX-401 reproducibly lowers low-density lipoprotein cholesterol (LDL-C) in non-human primates. The results support the continued clinical development of VXX-401 as a candidate for the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular disease.

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Scienmag

DECEMBER 15, 2020

Credit: BAT / KBP Investigational New Drug application approved by the FDA for COVID-19 candidate vaccine, allowing BAT to progress into a Phase I clinical trial in adult volunteers Vaccine candidate created using innovative plant-based technology Vaccines manufactured using BAT’s vaccine platform have the potential to be stable at room temperature (..)

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Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. According to GlobalData, Phase I drugs for Pandemic Influenza does not have sufficient historical data to build an indication benchmark PTSR for Phase I. Buy the report here.

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Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. According to GlobalData, Phase I drugs for Pandemic Influenza does not have sufficient historical data to build an indication benchmark PTSR for Phase I. Buy the report here.

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