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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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.

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Drug Discovery World

JUNE 28, 2023

MinervaX, a Danish biotechnology company developing a novel, prophylactic vaccine against Group B Streptococcus (GBS), has completed enrolment and initial dosing in its Phase I clinical vaccine trial in older adults. The trial is taking place at CEVAC (Centre for Vaccinology), Ghent University, Belgium.

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Clinical Trials Clinical Trials Trials Vaccination 52

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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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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World of DTC Marketing

APRIL 11, 2021

QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Based on the virus a number of vaccines targeting the spike protein were designed, tested in animal models and found to be quite promising against SARS and other coronavirus illnesses like Middle East respiratory syndrome.

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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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The Pharma Data

AUGUST 15, 2021

Even as several safe and effective COVID-19 vaccines are being administered to people worldwide, scientists are still hard at work developing different vaccine strategies that could provide even stronger or longer-lasting immunity against SARS-CoV-2 and its variants.

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Protein Vaccination Vaccine Antibody 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. “Our About the Phase 1/2 clinical trial.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

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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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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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

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.

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Antibody RNA Trials Clinical Trials 128

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.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. This is the focus of vaccines in development and convalescent plasma therapy.

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pharmaphorum

MARCH 12, 2021

Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals despite its background in vaccines. This means that the vaccine won’t be ready until next year, Sanofi’s chief executive Paul Hudson told Le Journal du Dimanche last month.

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Clinical Trials Clinical Trials Trials Vaccination 52

pharmaphorum

NOVEMBER 25, 2022

Scientists in the US say they have developed an mRNA-based vaccine that encompasses all 20 known subtypes of influenza that could form the basis of a future universal jab. The goals of the programme are also similar to those in COVID vaccine development.

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XTalks

JUNE 15, 2022

Last week, Novavax announced that it received positive feedback from the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) regarding the safety and efficacy of its COVID-9 vaccine (NVX-CoV2373). The Novavax COVID-19 Vaccine Candidate. The vaccine is given in two doses.

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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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Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 1 clinical trial, which is ongoing. Moderna Overview Moderna is a biotechnology company that focuses on the development of messenger RNA therapeutics and vaccines. The company develops and discovers drugs that produce proteins or antibodies inside patient cells.

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The Pharma Data

FEBRUARY 22, 2021

Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. If results are positive, Phase 3 study to start in Q2 2021, with vaccine expected to be available in Q4 2021. This new Phase 2 study will enable us to identify the final vaccine formulation for adults of all ages.

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Protein Vaccination Vaccine Immune Response 52

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)

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Pharmaceutical Technology

AUGUST 18, 2022

New Zealand’s Medsafe has granted expanded provisional approval for Novavax ’s protein-based Covid-19 vaccine Nuvaxovid (NVX-CoV2373) as a heterologous and homologous booster dose in adults aged 18 years and above. The booster vaccine is indicated for active immunisation for the prevention of Covid-19 in people of this age group.

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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.

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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

The Pharma Data

DECEMBER 16, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an Advance Purchase Agreement with the government of New Zealand for the purchase of 10.7 million doses of NVX-CoV2373, Novavax’ candidate vaccine against COVID-19. About NVX-CoV2373.

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Protein Vaccination Vaccine Immune Response 52

XTalks

JUNE 18, 2021

Despite increasing vaccinations, the need for COVID-19 treatments has not gone away, particularly in light of vaccine shortages and rising case numbers in some countries around the world. It is the first trial to demonstrate that any antibody treatment could improve survival in patients hospitalized with COVID-19.

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XTalks

JULY 2, 2021

There have been growing reports of women experiencing changes in their menstrual cycle after receiving a shot of a COVID-19 vaccine. Some women have said they got their periods early following vaccination, or that their periods were unusually heavy and/or painful. Related: Moderna’s COVID-19 Vaccine Effective Against New Variants.

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Vaccination Vaccine Protein Immune Response 105

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

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 94

pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. “But it may be; and if it doesn’t other novel vaccines with similar benefits may well take on this role.”

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Protein Vaccination Vaccine Immune Response 125

Pharmaceutical Technology

NOVEMBER 7, 2022

5 Omicron-targeting bivalent Covid-19 booster vaccine, mRNA-1273.222, for people aged 18 years and above. The 50µg vaccine is indicated for usage as a booster shot for active immunisation against Covid-19. 5 Omicron variants’ spike protein and 25µg encoding for the virus’ initial strain. 1 subvariant. 5 versus mRNA-1273.

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pharmaphorum

MARCH 30, 2022

CureVac and GlaxoSmithKline’s first attempt to develop a COVID-19 vaccine was a salutary reminder of the pitfalls in drug development, as the mRNA shot crashed and burned in a clinical trial last year, but they aren’t giving up. ” The post CureVac and GSK try again with COVID-19 vaccine appeared first on. .

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pharmaphorum

MAY 10, 2021

The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU. . Other data such as final clinical trial results will be assessed in due course. EMA_News starts evaluating the monoclonal antibody sotrovimab.

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Antibody Protein Trials Clinical Trials 52

XTalks

JANUARY 27, 2021

COVID-19 vaccine maker Moderna announced this week that results from a study show that the shot is effective against some of the new circulating variants of SARS-CoV-2. In a news release from Moderna, the company reported that the administration of its COVID-19 vaccine induced antibody titers against both variants.

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Vaccination Vaccine In-Vitro Protein 52

The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * efficacy against any symptomatic COVID-19 disease, in line with expected vaccine effectiveness in today’s environment dominated by variants of concern.

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