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.

Vaccination 94

Vaccination Vaccine Protein Clinical Trials 94

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.

Vaccination 263

Vaccination Vaccine Clinical Trials Clinical Trials 263

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.

Vaccination 264

Vaccination Vaccine Protein Clinical Trials 264

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.

Vaccination 363

Vaccination Vaccine Protein Clinical Trials 363

Drug Discovery World

FEBRUARY 28, 2024

The first 20 participants have been enrolled in a multicentre trial to test whether ImmunityBio’s Nant Cancer Vaccine (NCV) could potentially prevent colon and other cancers in individuals with Lynch syndrome. The vaccine comprises a tri-valent Adenovirus (Tri-Ad5) in combination with the company’s IL-15 superagonist N-803.

Vaccination 52

Vaccination Vaccine Trials Protein 52

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

Bio Pharma Dive

MAY 19, 2023

The biotech, best known for its vaccine research, said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.

RNA 287

RNA Medicine Clinical Trials Clinical Trials 287

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.

Vaccination 147

Vaccination Vaccine Immune Response Protein 147

Pharmaceutical Technology

MAY 29, 2023

Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU). The safety and efficacy of Nuvaxovid was evaluated as a primary series.

Vaccination 130

Vaccination Vaccine Protein Immune Response 130

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.

Vaccination 147

Vaccination Vaccine Clinical Trials Clinical Trials 147

pharmaphorum

JULY 27, 2022

Pfizer and BioNTech have started a mid-stage trial of a new version of the COVID-19 vaccine based on a version of the spike protein that they hope will offer greater and broader protection against SARS-CoV-2 variants. The post Pfizer takes COVID jab with ‘enhanced’ spike protein into phase 2 appeared first on.

Protein 121

Protein Immune Response Vaccination Vaccine 121

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.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

Bio Pharma Dive

SEPTEMBER 25, 2020

The Maryland-based biotech is the first developer to advance a more traditional protein-based vaccine into the final stages of clinical testing.

Vaccination 201

Vaccination Vaccine Protein Trials 201

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.,

Vaccination 59

Vaccination Vaccine Trials Clinical Trials 59

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.

Vaccination 130

Vaccination Vaccine Clinical Trials Clinical Trials 130

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. The trial will enrol up to 50 healthy volunteers aged 18 to 49.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Pharmaceutical Technology

NOVEMBER 11, 2022

The European Commission (EC) has granted approval for Sanofi and GSK ’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18 years and above. It is indicated as a booster in people of this age group who were earlier inoculated with a Covid-19 vaccine.

Vaccination 246

Vaccination Vaccine Immune Response Protein 246

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.

Vaccination 130

Vaccination Vaccine Clinical Trials Clinical Trials 130

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

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.

Vaccination 147

Vaccination Vaccine Clinical Trials Clinical Trials 147

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.

Vaccination 147

Vaccination Vaccine Clinical Trials Clinical Trials 147

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

Vaccination 87

Vaccination Vaccine Trials Protein 87

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.

Vaccination 95

Vaccination Vaccine Trials Immune Response 95

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.

Vaccination 162

Vaccination Vaccine Clinical Trials Clinical Trials 162

BioSpace

NOVEMBER 7, 2022

Researchers from the University of Washington have developed an investigational vaccine that can safely elicit an immune response against the HER2 protein, a key marker in breast cancer.

Immune Response 98

Immune Response Vaccination Vaccine Protein 98

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. .

Vaccination 98

Vaccination Vaccine Trials Immune Response 98

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.

Vaccination 52

Vaccination Vaccine Protein Antibody 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.

Vaccination 52

Vaccination Vaccine Trials Antibody 52

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.

Vaccination 68

Vaccination Vaccine Trials DNA 68

Pharmaceutical Technology

AUGUST 23, 2022

5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 5-adapted bivalent vaccine will be made readily available for shipping. 5 variant spike protein.

Vaccination 130

Vaccination Vaccine Gene Therapy Protein 130

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 →

Clinical Trials 52

Clinical Trials Clinical Trials Protein Vaccination 52

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.

Immune Response 104

Immune Response Vaccination Vaccine Trials 104

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. Related: Red Meat Allergy Test Gets FDA Clearance. “We

Clinical Trials 75

Clinical Trials Clinical Trials Vaccination Vaccine 75

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).

Vaccination 52

Vaccination Vaccine Immune Response RNA 52

BioPharma Reporter

JULY 12, 2021

Antibody responses against the SARS-CoV-2 spike protein were found in 99% of volunteers after the second dose of ReiTheraâs COVID-19 vaccine candidate, according to Phase 2 preliminary data.

Vaccination 105

Vaccination Vaccine Protein Antibody 105

Drug Discovery World

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic. References .

Vaccination 52

Vaccination Vaccine Trials Bacteria 52

pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Pfizer will pay up to $45 million in development related milestone payments and up to $143 million if the vaccine hits early sales targets.

Vaccination 118

Vaccination Vaccine Bacterium Protein 118