Pharmaceutical Technology

SEPTEMBER 19, 2022

The EMA CHMP positive opinion is based on findings from the double-blind, randomised, placebo-controlled, multicentre Phase III TACKLE clinical trial of IM dose of Evusheld. Additionally, in the trial, the antibody cocktail was found to be well-tolerated. 5 variant, the company noted.

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In-Vitro Antibody Vaccination Vaccine 279

pharmaphorum

SEPTEMBER 4, 2020

Sanofi and GlaxoSmithKline have begun clinical trials of their coronavirus vaccine, as AstraZeneca expanded studies of its rival into Japan. The French pharma in April joined forces with the UK’s GSK to produce the vaccine, with Sanofi contributing an antigen that produces the immune reaction.

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Clinical Trials Clinical Trials Vaccination Vaccine 106

Pharmaceutical Technology

DECEMBER 27, 2022

Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced. A few months later, the monkeypox outbreak showed the difficulty in accessing vaccines and antivirals despite a plan to stockpile them. Tracking the news.

Clinical Trials 306

Clinical Trials Clinical Trials Trials Vaccination 306

pharmaphorum

JANUARY 21, 2022

A third dose of vaccine has been shown to effectively neutralise the Omicron variant of covid-19, according to researchers. Research led by UCLH, UCL and the Francis Crick Institute found that the booster dose successfully stimulates antibody levels that neutralise Omicron. Overall, antibody levels were nearly 2.5

Antibody 115

Antibody Vaccination Vaccine Genotype 115

Pharmaceutical Technology

MARCH 31, 2023

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March.

Vaccination 277

Vaccination Vaccine Immune Response Antibody 277

XTalks

NOVEMBER 12, 2024

Moreover, in low- and middle-income countries, lack of healthcare access increases the disease’s impact, as limited diagnostics, vaccination coverage and medical resources limit early detection and treatment. Monoclonal Antibody Therapies Monoclonal antibodies are gaining traction as targeted treatments for bacterial and viral infections.

Bacteria 110

Bacteria Life Science Vaccination Vaccine 110

XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus.

Immune Response 59

Immune Response Vaccination Vaccine Trials 59

Pharmaceutical Technology

DECEMBER 18, 2022

The 0.25mL dose of the booster vaccine could potentially be used in the European Union (EU) following authorisation in these children a minimum of three months following a previous Covid-19 vaccination. The EMA positive opinion is based on clinical findings of mRNA.1273.214, 5), mRNA-1273.

Gene Therapy 304

Gene Therapy Vaccination Vaccine Clinical Trials 304

Pharmaceutical Technology

JULY 18, 2022

Moderna has received provisional registration from the Australian Therapeutic Goods Administration (TGA) for its messenger RNA (mRNA) Covid-19 vaccine, Spikevax, for kids aged six months to five years. The 25µg two-dose vaccine regimen is indicated for active immunisation for the prevention of Covid-19.

Vaccination 246

Vaccination Vaccine Gene Therapy Antibody 246

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.

Vaccination 162

Vaccination Vaccine Antibody Development 162

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.

Vaccination 145

Vaccination Vaccine Trials Immune Response 145

pharmaphorum

SEPTEMBER 17, 2020

Eli Lilly has followed up supportive data from its Olumiant in COVID-19 with results of a study showing its antibody treatment could help prevent hospitalisation from the disease. The double-blind placebo-controlled antibody study involved patients with symptoms outside hospitals, who were treated with four different dose strengths.

Antibody 129

Antibody RNA Trials Clinical Trials 129

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.

Vaccination 130

Vaccination Vaccine Antibody Trials 130

Pharmaceutical Technology

SEPTEMBER 2, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting expanded conditional marketing authorization (CMA) for Novavax ’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), as a booster in adults aged 18 years and above.

Vaccination 147

Vaccination Vaccine Trials Clinical Trials 147

Pharmaceutical Technology

JANUARY 19, 2023

The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

Vaccination 147

Vaccination Vaccine Immune Response Protein 147

Medical Xpress

DECEMBER 2, 2022

working with two colleagues from Sweden, reports promising results in a phase I clinical trial aimed at testing the efficacy and safety of an HIV vaccine. A large team of researchers affiliated with a host of institutions across the U.S.,

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

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.

Vaccination 134

Vaccination Vaccine Clinical Trials Clinical Trials 134

pharmaphorum

JULY 8, 2021

Buoyed by the success of its COVID-19 vaccine, Moderna has started a phase 1/2 trials of its mRNA-based shot for seasonal influenza, targeting four different flu strains. . They could offer a more potent option to conventional flu shots, according to mRNA vaccine developers. billion in sales in the first quarter of the year.

Vaccination 145

Vaccination Vaccine Trials Clinical Trials 145

BioPharma Reporter

OCTOBER 11, 2022

Intranasal delivery of ChAdOx1 nCoV-19 failed to induce either a consistent mucosal antibody response or a strong systemic immune response, according to results from a Phase 1 clinical trial released today.

Immune Response 116

Immune Response Vaccination Vaccine Clinical Trials 116

BioPharma Reporter

SEPTEMBER 1, 2021

The US National Institutes of Health (NIH) has begun a clinical trial to assess the antibody response to a COVID-19 vaccine booster in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen.

Vaccination 105

Vaccination Vaccine Clinical Trials Clinical Trials 105

pharmaphorum

JULY 6, 2021

A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. The post Imugene HER2 vaccine hits target in stomach cancer trial appeared first on.

Vaccination 119

Vaccination Vaccine Trials Antibody 119

pharmaphorum

JULY 18, 2022

MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, How it works.

Vaccination 138

Vaccination Vaccine Development Immune Response 138

Pharmaceutical Technology

AUGUST 24, 2022

5 Omicron-targeting bivalent booster vaccine for Covid-19. The submission is made for a 50µg booster dose of the vaccine for usage in adults aged 18 years and above. According to the findings, the trial of mRNA-1273.214 met all primary endpoints. At present, a Phase II/III trial of mRNA-1273.222 is progressing.

Vaccination 130

Vaccination Vaccine Gene Therapy Antibody 130

pharmaphorum

FEBRUARY 25, 2021

Pfizer/BioNTech’s mRNA vaccine against COVID is a technical marvel – but the ultra-cool temperatures required for storage and stability has been tricky to handle. The company announced a phase 1 trial is beginning of its nasal spray vaccine just as scientists in the UK said they are considering a similar approach.

Vaccination 111

Vaccination Vaccine Immune Response Trials 111

XTalks

MAY 4, 2023

A blood test can detect antibodies to gluten, but a definitive diagnosis requires a biopsy of the small intestine. 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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Clinical Trials Clinical Trials Trials Immune Response 98

Pharmaceutical Technology

JULY 29, 2022

The company submitted the BLA based on positive data from various studies of the investigational therapy, including the Phase II/III QUILT 3.032 clinical trial underway. The open-label, three-cohort, multicentre trial analysed intravesical BCG, N-803 combination in BCG-unresponsive high-grade NMIBC patients.

Trials 264

Trials Clinical Trials Clinical Trials Licensing 264

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.

Vaccination 130

Vaccination Vaccine Gene Therapy Protein 130

JAMA Internal Medicine

DECEMBER 19, 2021

This randomized clinical trial evaluated the effectiveness of a third dose of mRNA-based vs a vector-based vaccine in 201 kidney transplant recipients with no SARS-CoV-2 antibodies after 2 prior doses of an mRNA vaccine.

Antibody 68

Antibody Vaccination Vaccine Clinical Trials 68

pharmaphorum

JULY 27, 2021

Early-stage clinical data with CanSino Biologics’ inhaled COVID-19 vaccine show that it was able to stimulate neutralising antibodies against SARS-CoV-2 at a dose well below that required with intramuscular administration. CanSino moved the inhaled formulation into clinical testing in April.

Vaccination 98

Vaccination Vaccine Antibody Immune Response 98

Pharmaceutical Technology

JUNE 8, 2023

Gritstone bio has reported interim results from an ongoing Phase 1 study evaluating the company’s self-amplifying mRNA (samRNA) vaccine as a boost against Covid-19 (CORAL-BOOST). The Phase I CORAL-BOOST dose-escalation trial (NCT05148962) evaluated Gritstone’s samRNA candidate (GRT-R910) in previously vaccinated healthy older adults.

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Vaccination Vaccine Immune Response Allergies 130

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.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

pharmaphorum

SEPTEMBER 22, 2022

Alexandre Le Vert, CEO and co-founder of Osivax, discusses the company’s breakthrough vaccine technology, oligoDOM, and how it’s driving the development of new influenza and SARS-CoV-2 vaccines that attack T-cells, providing a long-lasting effect. Antibodies cover the pathogen of the virus and neutralise it.

Vaccination 97

Vaccination Vaccine Antibody Clinical Trials 97

pharmaphorum

JANUARY 13, 2021

IO Biotech, an oncology specialist formed and backed by Denmark’s Novo Holdings, has raised €127 million ($155 million) to further develop its cancer vaccine technology that has boosted efficacy of PD-1 immunotherapy in early trials. The post IO Biotech raises $155m to develop breakthrough cancer vaccine appeared first on.

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Vaccination Vaccine Development In-Vivo 95

Medical Xpress

MARCH 16, 2023

An experimental COVID-19 vaccine produced with technology based on a decades-old method, elicited virus-neutralizing antibodies in higher proportion than the amount induced by mRNA immunizations, a Phase 1 clinical trial has found.

Antibody 75

Antibody Clinical Trials Clinical Trials Vaccination 75

pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

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Regulation Vaccination Vaccine Protein 105

XTalks

JANUARY 31, 2022

COVID-19 vaccine makers Pfizer/BioNTech and Moderna have both commenced trials for their new variant-specific vaccines targeting omicron. Pfizer and BioNTech have started to enroll participants in a study that will evaluate the new version of their COVID-19 vaccine that targets the omicron variant of SARS-CoV-2.

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Vaccination Vaccine Trials Antibody 98

Scienmag

MARCH 24, 2021

Department of Defense When clinical trials were conducted to determine the immunogenicity — the ability to elicit an immune response — for the first two vaccines marshaled against SARS-CoV-2the virus that causes COVID-19, one group was not among those included: people who have received solid organ […].

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Immune Response Vaccination Vaccine Antibody 78