World of DTC Marketing

DECEMBER 29, 2020

OBSERVATION: Biologics can take a long time to develop but COVID vaccines have been in development for almost 50 years and novel approaches were used to develop these vaccines. Vaccines typically take 10 to 15 years to develop, test and release to the public. The coronavirus vaccines, however, took less than a year.

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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

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

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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Pharmaceutical Technology

SEPTEMBER 5, 2022

The National Medical Products Administration of China (NMPA) has approved CanSino Biologics ’ (CanSinoBIO) recombinant Covid-19 vaccine (Adenovirus Type 5 Vector) for inhalation, Convidecia Air, as a booster. This vaccine leverages the same adenovirus vector technological platform as Convidecia, the intramuscular version.

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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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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.

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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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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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Pharmaceutical Technology

AUGUST 17, 2022

On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. This means that the vaccine works against multiple serotypes of the disease, she explains. In June 2022, Pfizer acquired 8.1%

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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.

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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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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.

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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.

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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

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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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

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.

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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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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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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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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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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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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.

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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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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 93

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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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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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.

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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.

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pharmaphorum

FEBRUARY 22, 2021

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults.

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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.

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

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Clinical Trials Clinical Trials Vaccination Vaccine 73

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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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.

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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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