XTalks

MAY 4, 2023

Celiac disease is an autoimmune disorder that is triggered by the consumption of gluten, a protein found in barley, wheat and rye. 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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XTalks

FEBRUARY 19, 2024

Moderna has been testing an experimental mRNA vaccine aimed at combating the human cytomegalovirus (CMV), which poses significant health risks to newborns and immunocompromised patients. The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine.

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Vaccination Vaccine Trials Clinical Trials 59

Pharmaceutical Technology

JULY 6, 2022

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain.

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XTalks

JULY 19, 2022

The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) to Novavax’s COVID-19 vaccine, making it the fourth authorized vaccine in the US against COVID-19. The vaccine is branded as Nuvaxovid outside the US with approvals/authorizations in Canada, the EU, UK, Australia and South Korea.

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XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial.

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XTalks

MAY 7, 2021

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 These results came from data from Novavax’s Phase III UK trial where B.1.117

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Protein Vaccination Vaccine Trials 97

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. OspA is a surface protein expressed by the bacteria when present in a tick.

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Clinical Trials Clinical Trials Vaccination Vaccine 76

pharmaphorum

MAY 19, 2022

Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. One candidate – mRNA-1644 – has already shown its potential in an earlier phase 1 trial (IAVI G001) run in the US.

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Vaccination Vaccine Trials Immune Response 145

Drug Discovery World

JUNE 28, 2023

MinervaX, a Danish biotechnology company developing a novel, prophylactic vaccine against Group B Streptococcus (GBS), has completed enrolment and initial dosing in its Phase I clinical vaccine trial in older adults. The trial is taking place at CEVAC (Centre for Vaccinology), Ghent University, Belgium.

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Clinical Trials Clinical Trials Trials Vaccination 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

Novavax and Serum Institute of India (SII) have reported that the former’s Covid-19 vaccine, NVX-CoV2373, has received full product registration from the South African Health Products Regulatory Authority (SAHPRA), with conditions. This data also comprises two Phase III clinical trials: a trial in the UK and PREVENT-19 in the US and Mexico.

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BioPharma Reporter

SEPTEMBER 3, 2020

Sanofi and GSK today start the Phase 1/2 clinical trial for their COVID-19 adjuvanted recombinant protein-based vaccine candidate.

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Clinical Trials Clinical Trials Vaccination Vaccine 83

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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BioTech 365

AUGUST 5, 2021

Akston Biosciences Doses First Subjects in Phase II Clinical Trial of Second-Generation Protein Subunit COVID-19 Vaccine Akston Biosciences Doses First Subjects in Phase II Clinical Trial of Second-Generation Protein Subunit COVID-19 Vaccine First Phase II subjects dosed with AKS-452, COVID-19 … Continue reading →

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XTalks

SEPTEMBER 21, 2023

announced that the first participant has been dosed in a new Phase I trial for an innovative HIV vaccine candidate, VIR-1388. The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. Vir Biotechnology, Inc.,

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Vaccination Vaccine Trials Clinical Trials 59

Drug Discovery World

SEPTEMBER 25, 2023

Enrolment in a Phase I trial of a new investigational universal influenza vaccine candidate has begun at the National Institutes of Health’s Clinical Center in Bethesda, Maryland, US. An ideal universal influenza vaccine could be taken less frequently than once a year and protect against multiple strains of influenza virus.

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Vaccination Vaccine Trials Immune Response 52

Pharma Mirror

SEPTEMBER 11, 2022

Bandung, W Java, Indonesia, PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a new milestone in the manufacturing of IndoVac, a Covid-19 vaccine brand it has developed since November 2021.

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pharmaphorum

JANUARY 18, 2022

Cancer Research UK’s Centre for Drug Development, working with the Ludwig Institute for Cancer Research and Vaccitech, has begun a phase I/IIa clinical trial of a new lung cancer vaccine. Vaccitech and the Ludwig Institute are providing the drug while the Centre manages the trial and provides funding.

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Clinical Trials Clinical Trials Trials Vaccination 62

Pharmaceutical Technology

FEBRUARY 15, 2023

Clover Biopharmaceuticals has launched its recombinant SARS-CoV-2 subunit vaccine , a protein-based Covid-19 vaccine, in China. In December last year, Clover’s Covid-19 vaccine received emergency use authorisation in the country. 5, in a separate Phase III trial. 5, in a separate Phase III trial.

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Pharmaceutical Technology

OCTOBER 20, 2022

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Novavax ’s adjuvanted Covid-19 vaccine, NVX-CoV2373, as a booster for use in people aged 18 years and above. The booster is indicated for use after a minimum of six months following a vaccine regimen with an authorised or approved Covid-19 shot.

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Pharmaceutical Technology

JULY 27, 2022

Novavax has r eceived expanded approval for provisional registration from the Australian Therapeutic Goods Agency (TGA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. It is the first protein-based vaccine to be offered in Australia for adolescents aged 12 to 17 years.

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Vaccination Vaccine Clinical Trials Clinical Trials 147

pharmaphorum

NOVEMBER 4, 2020

It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease.

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Clinical Trials Clinical Trials Trials Vaccination 104

The Pharma Data

DECEMBER 20, 2020

UK drug developer Scancell said it has chosen a COVID-19 vaccine candidate, SN14, from more than a dozen potential products to advance to a clinical trial. . SN14 works by targeting the coronavirus’ nucleocapsid and spike proteins to prevent viral replication using the company’s ImmunoBody DNA vaccine technology.

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Pharmaceutical Technology

JULY 14, 2022

Novavax has obtained the US Food and Drug Administration (FDA) emergency use authorization (EUA) for its Covid-19 vaccine. The EUA for the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has been granted for providing a two-dose primary series for active immunisation aimed at preventing the disease in individuals aged 18 years and above.

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Pharmaceutical Technology

AUGUST 14, 2022

Novavax and its partner SK bioscience have obtained a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), to be used in adolescents of the age 12 to 17 years. It enrolled 2,247 adolescents across 73 US sites.

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BioPharma Reporter

DECEMBER 11, 2020

Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. “Our About the Phase 1/2 clinical trial.

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Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. The mRNA constructs used in COVID-19 vaccines, for example, direct cells to produce a version of the “spike” protein studding the surface of SARS-CoV-2.

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pharmaphorum

MARCH 12, 2021

Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals despite its background in vaccines. This means that the vaccine won’t be ready until next year, Sanofi’s chief executive Paul Hudson told Le Journal du Dimanche last month.

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Clinical Trials Clinical Trials Trials Vaccination 52

Drug Discovery World

DECEMBER 6, 2022

While scientists have struggled in the past to create an effective vaccine against HIV, a novel vaccine design strategy shows new promise, according to data from a first-in-human clinical trial. . The Phase I trial (IAVI G001) tested the first stage in a multi-stage HIV vaccine regimen the researchers are developing.

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Vaccination Vaccine Trials Antibody 52

pharmaphorum

NOVEMBER 25, 2021

The first patients are now being treated as part of a first-in-human trial of a vaccine, administered as a nasal spray, that aims to slow down the progression of Alzheimer’s disease (AD). Meanwhile researchers in Japan are also running preclinical studies of an intranasal tau vaccine.

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Pharmaceutical Technology

AUGUST 23, 2022

5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. The submission comes after the regulatory agency provided guidance to incorporate clinical findings of the bivalent Omicron BA.1-adapted 1-adapted vaccine. 5-adapted bivalent vaccine will be made readily available for shipping.

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pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. .

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Vaccination Vaccine Trials Immune Response 98

Drug Discovery World

FEBRUARY 19, 2024

Replicate Bioscience has shared positive results from the Phase I trial of RBI-4000, its srRNA-based rabies vaccine. In this clinical trial, evaluating safety and immunogenicity of RBI-4000 , participants received one or two doses of srRNA vaccine at low doses (0.1mcg, 1mcg or 10mcg).

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pharmaphorum

FEBRUARY 9, 2022

In this article, Ben Hargreaves looks into the promise of cancer vaccines and how this treatment modality may offer advantages over existing immunotherapies in the oncology sector. One area that is gathering increasing levels of interest is the development of cancer vaccines. A broad front.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

World of DTC Marketing

APRIL 11, 2021

QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Based on the virus a number of vaccines targeting the spike protein were designed, tested in animal models and found to be quite promising against SARS and other coronavirus illnesses like Middle East respiratory syndrome.

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Scienmag

MARCH 15, 2021

The first vaccine has been administered in a comparative adjuvant trial of DNA prime/protein boost HIV vaccine regimens in Kericho, Kenya Credit: U.S. Military HIV Research Program SILVER SPRING, Md.

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