Pharmaceutical Technology

AUGUST 15, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. It comprises mRNA-1273 (Spikevax) and a vaccine candidate that acts on the SARS-CoV-2 virus’ BA.1

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Vaccination Vaccine Immune Response Clinical Trials 214

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

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

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.

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Vaccination Vaccine Trials Antibody 118

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. Across three separate preclinical studies in cynomolgus monkeys, VXX-401 induced a strong and durable antibody response against PCSK9, and robust, sustained reduction of LDL-C over time.

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Vaccination Vaccine Antibody Clinical Trials 104

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

BioSpace

JANUARY 25, 2021

Regeneron announced positive initial data from its ongoing Phase III trial of its antibody cocktail, REGEN-COV, as a passive vaccine to prevent COVID-19 in people at high risk of infection from household exposure.

Antibody 95

Antibody Vaccination Vaccine Trials 95

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.

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Vaccination Vaccine Immune Response Trials 110

Drug Discovery World

SEPTEMBER 15, 2023

Replicate Bioscience has dosed the first participant in a Phase I trial of its RBI-4000 vaccine for the prevention of rabies. Rabies, RBI-4000 and the Phase I trial Rabies remains a public health threat in several geographical regions and is designated an NIAID Priority Pathogen.

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Vaccination Vaccine Trials Immune Response 52

Pharmaceutical Technology

JUNE 20, 2023

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator.

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Vaccination Vaccine Protein Clinical Trials 363

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.,

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Clinical Trials Clinical Trials Vaccination Vaccine 76

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. A non-temperature stable form of the candidate previously had been tested in several clinical trials.

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Immune Response Vaccination Vaccine Trials 75

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

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

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 75

Antibody Vaccination Vaccine Clinical Trials 75

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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Vaccination Vaccine Trials Immune Response 95

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

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

Pharmaceutical Technology

SEPTEMBER 15, 2022

Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. YoY revenue growth.

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Vaccination Vaccine Sales Generic Drugs 272

BioTech 365

APRIL 12, 2021

Valneva Completes Recruitment for Pivotal Phase 3 Trial of Chikungunya Vaccine Candidate and Initiates Antibody Persistence Trial Valneva Completes Recruitment for Pivotal Phase 3 Trial of Chikungunya Vaccine Candidate and Initiates Antibody Persistence Trial Saint-Herblain (France), April 12, 2021 – … Continue reading →

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Antibody Trials Vaccination Vaccine 40

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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Vaccination Vaccine Immune Response RNA 52

Drug Discovery World

AUGUST 15, 2022

A monoclonal antibody (mAb) treatment for the prevention of Malaria has shown encouraging results in a US Phase I clinical trial. . The mAb, known as L9LS, was developed by scientists at the National Institutes of Health’s (NIH) Vaccine Research Centre (VRC). Kenya, where malaria is endemic. . Official comments .

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Trials Vaccination Vaccine Clinical Trials 52

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 96

Drug Discovery World

JANUARY 3, 2023

A monoclonal antibody to prevent Covid-19 in vulnerable patients, AZD3152, has entered clinical trials less than 12 months after discovery. . The commencement of the trial triggers a $5 million milestone payment to RQ Bio and will enable the company to execute its four scientific programmes focused on viral diseases. .

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Antibody Development Immune Response Clinical Trials 52

BioTech 365

OCTOBER 7, 2020

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Chinese COVID-19 vaccine trial reports falling antibody titers.Chinese COVID-19 vaccine trial reports falling antibody titers ntaylor Wed, 10/07/2020 – 08:57 from FierceBiotech: Biotech [link].

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Antibody Vaccination Vaccine Trials 40

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

JANUARY 13, 2022

Preliminary data from an ongoing trial of AstraZeneca’s COVID-19 vaccine Vaxzevria has shown that a booster dose stimulates an increase in antibodies against Omicron, as well as other variants of the virus, including Alpha, Beta, Delta, and Gamma. billion doses administered. billion doses administered.

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Antibody Immune Response Vaccination Vaccine 97

STAT News

NOVEMBER 4, 2022

New data from Pfizer and BioNTech on their bivalent Covid-19 vaccine suggests the updated product may be more protective against more recent Omicron subvariants than the original version of the vaccine, the companies said in a statement released Friday. The companies said the levels of neutralizing antibodies that target the BA.4

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Vaccination Vaccine Antibody Production 141

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

Drug Discovery World

OCTOBER 11, 2023

MinervaX, a Danish biotechnology company developing a novel, prophylactic vaccine against Group B streptococcus (GBS), has announced the completion of €54 million upsized financing. GBS is a leading cause of life-threatening infections in newborns as well as adverse pregnancy outcomes such as preterm delivery and stillbirths.

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Vaccination Vaccine Clinical Trials Clinical Trials 59

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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Vaccination Vaccine Protein Antibody 52

The Pharma Data

SEPTEMBER 14, 2020

Illustration of antibodies attacking the coronavirus. A new antibody treatment is to be trialled on Covid-19 patients in UK hospitals. Monoclonal antibodies, which are potent, laboratory-made antibodies, will be given to about 2,000 people to see if they are effective against coronavirus. What are monoclonal antibodies?

Antibody 52

Antibody Trials Immune Response Vaccination 52

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

BioSpace

OCTOBER 17, 2021

proved itself superior to AZD1222 (ChAdOx1-S), the vaccine by Astrazeneca-Oxford, in terms of geometric mean titer for neutralization antibodies.

Vaccination 98

Vaccination Vaccine Antibody Trials 98

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

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

Drug Discovery World

NOVEMBER 2, 2022

One dose of an antibody drug safely protected healthy, non-pregnant adults from malaria infection during an intense six-month malaria season in Mali, Africa. . The antibody was up to 88.2% The Phase II NIAID-USTTB trial evaluated a one-time, intravenous infusion of a monoclonal antibody called CIS43LS. .

Antibody 52

Antibody Allergies Trials Medicine 52