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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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.

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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.

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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.

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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.

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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.

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Vaccination Vaccine Clinical Trials Clinical Trials 105

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.

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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.

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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

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 74

Antibody Vaccination Vaccine Clinical Trials 74

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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Vaccination Vaccine Gene Therapy Protein 130

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.

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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.

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Clinical Trials Clinical Trials Vaccination Vaccine 76

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

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

The Pharma Data

AUGUST 27, 2020

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . Each patient was given two 100 microgram doses of the vaccine 28 days apart. There is hope that Moderna’s vaccine could be available by early 2021. .

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Vaccination Vaccine Immune Response Antibody 90

pharmaphorum

AUGUST 14, 2020

The UK is to buy millions more doses of potential coronavirus vaccines from Johnson & Johnson and Novavax, with the latter expanding its manufacturing operation in the country. Novavax said separately that the UK is buying a further 60 million doses of its vaccine candidate, NVX-CoV2373 for a phase 3 clinical trial.

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Vaccination Vaccine Clinical Trials Clinical Trials 95

pharmaphorum

JUNE 9, 2022

Moderna’s new version of its COVID-19 vaccine, which targets two virus variants including Omicron, has outperformed the company’s original Spikevax shot in a head-to-head clinical trial. It has predicted sales of COVID-19 vaccines will be around $21 billion this year.

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Vaccination Vaccine Containment Clinical Trials 105

pharmaphorum

SEPTEMBER 7, 2020

A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. The vaccine also produced a T-cell response within 28 days, a secondary outcome.

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Immune Response Vaccination Vaccine Trials 107

XTalks

JULY 25, 2023

Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). How Does Cyfendus Work? mL for intramuscular injection.

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FDA Approval Vaccination Vaccine Antibody 98

XTalks

DECEMBER 14, 2021

Moderna revealed the first interim results from a small, Phase I study of its mRNA-based influenza vaccine, which showed that the vaccine had no significant safety concerns and elicited immune responses against four strains of the influenza virus. Antibody levels against the A strains were higher than the B subtypes.

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Vaccination Vaccine Immune Response Antibody 98

Scienmag

JUNE 27, 2022

A major clinical trial, led by experts at the University of Nottingham working in partnership with several Universities and NHS hospitals, has found that by interrupting the treatment of vulnerable people on long-term immune supressing medicines for two weeks after a COVID-19 booster vaccination, their antibody response to the jab is doubled.

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Antibody Medicine Vaccination Vaccine 60

pharmaphorum

AUGUST 16, 2020

The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million. The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine.

Vaccination 111

Vaccination Vaccine Immune Response Trials 111

Medical Xpress

MARCH 6, 2023

A clinical trial testing a freeze-dried, temperature-stable experimental tuberculosis (TB) vaccine in healthy adults found that it was safe and stimulated both antibodies and responses from the cellular arm of the immune system. Results are published in Nature Communications.

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Immune Response Vaccination Vaccine Trials 75

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.

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Vaccination Vaccine Protein Immune Response 111

XTalks

MARCH 1, 2021

(NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. The study will be a part of current Phase I, II and III trials.

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Vaccination Vaccine Development In-Vitro 111

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

XTalks

SEPTEMBER 23, 2021

NYSE: PFE ) and BioNTech SE ( Nasdaq: BNTX ) announced the very first results from a pivotal trial being conducted for their COVID-19 vaccine for children on Monday. The results showed that the vaccine was safe, well-tolerated and produced robust neutralizing antibody responses in children five to 11 years old.

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Vaccination Vaccine Trials Antibody 98

pharmaphorum

SEPTEMBER 7, 2020

Politicking between China and Canada threatened to slow down development of a coronavirus vaccine from CanSino Biologics, but the company says the project is back on track following regulatory approval to start trials in Russia. The post Losing ground in COVID-19 vaccine race, CanSino turns to Russia appeared first on.

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Vaccination Vaccine Clinical Trials Clinical Trials 90

pharmaphorum

JULY 20, 2021

The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. The phase 3 trial being run in support of approval is using a two-shot regimen, with the first dose targeting the original SARS-CoV-2 virus and the second targeting beta (B.1.351)

Vaccination 98

Vaccination Vaccine Protein Immune Response 98

XTalks

JUNE 16, 2021

Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4 Related: Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351

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Vaccination Vaccine Protein Trials 98

pharmaphorum

SEPTEMBER 27, 2022

Ben Hargreaves finds that the next step to enhance these treatments further could be to find synergies with emerging therapies employing similar modes of action, such as therapeutic cancer vaccines. One area that is becoming more widely discussed with the potential to be added to this group is that of therapeutic cancer vaccines.

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Vaccination Vaccine Trials Clinical Trials 97