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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Vaccination Vaccine Immune Response Antibody 277

NY Times

MAY 11, 2022

Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.

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Immune Response Vaccination Vaccine Antibody 62

Drug Discovery World

MARCH 26, 2024

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis (prevention) of Covid-19.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

Drug Discovery World

APRIL 3, 2023

A team of researchers at the Keck School of Medicine of University of Southern California (USC) have found a drug with the potential for curbing painful hyperinflammation from osteoarthritis, according to results of an animal study.

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Clinical Trials Clinical Trials Trials Drugs 52

The Pharma Data

JANUARY 25, 2021

Regeneron’s monoclonal antibody cocktail reduced medical visits for COVID-19 patients who had not been hospitalized by almost 50 percent, according to interim clinical trial results reported by researchers at the company. The FDA granted Regeneron’s antibody cocktail Emergency Use Authorization in November.

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Antibody Immune Response Clinical Trials Clinical Trials 52

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

Scienmag

JUNE 28, 2021

Phase 1/2 clinical trial of CoronaVac in 550 children and adolescents aged 3-17 years in China suggests two doses of the vaccine are safe and generate a strong antibody response.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Clinical Trials Clinical Trials Vaccination Vaccine 76

The Pharma Data

JUNE 17, 2022

Two broadly neutralizing antibodies show great promise to provide long-acting immunity against COVID-19 in immunocompromised populations according to a paper published June 15 in the Journal of Experimental Medicine (JEM). The two antibodies also were fully active against Alpha, Beta, Gamma, and Delta variants.

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Antibody In-Vivo In-Vitro Immune Response 52

The Pharma Data

JANUARY 22, 2021

Regeneron’s monoclonal antibody cocktail reduced medical visits for COVID-19 patients who had not been hospitalized by almost 50 percent, according to interim clinical trial results reported by researchers at the company. The lead author, David Weinreich, and several co-authors work for Regeneron. 24, 2020 ).

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Antibody Immune Response Clinical Trials Clinical Trials 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. About the Phase 1/2 clinical trial. About Translate Bio.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

OCTOBER 12, 2022

Genomic medicine is a rapidly growing space in which researchers use the information in a person’s genes to identify and administer medical treatment.”. The evolving field of genomic medicine. There are two components to genomic medicine, known as the payload and the vector. Forging an AI-enabled path toward precision medicine.

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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. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. “As

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Antibody Vaccination Vaccine In-Vitro 52

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. Personalized medicine using genetic resequencing techniques, such as cell and gene therapies, enables researchers to create more customized therapies for combatting cancer.

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The Pharma Data

APRIL 15, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. About the Phase 1/2/3 Trial in Children.

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Immune Response Vaccination Vaccine Clinical Trials 52

The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , Yancopoulos , M.D.,

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Drug Discovery World

MARCH 27, 2023

The first subjects have been dosed in a Phase I clinical trial of VXX-401, an investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol, a known factor in heart disease. We’re excited to get this first-in-human trial of VXX-401 started.

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Vaccination Vaccine Antibody Immune Response 52

Drug Discovery World

JANUARY 18, 2024

Poolbeg Pharma, a biopharmaceutical company focused on the development and commercialisation of medicines targeting diseases with a high unmet medical need, has announced promising in vivo results for POLB 001 in addressing cancer immunotherapy-induced cytokine release syndrome (CRS). million cases of cancer by 2030 1,2.

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In-Vivo Antibody Clinical Trials Clinical Trials 64

The Pharma Data

DECEMBER 7, 2020

In an early-stage clinical trial with 65 volunteers in the United States, an experimental vaccine triggered strong immune responses to a wide range of flu virus strains and subtypes. The immune responses lasted at least 18 months, according to the researchers at Mount Sinai Health System, in New York City.

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Vaccination Vaccine Scientist Immune Response 52

Sciensano

JULY 5, 2023

This symposium will be an opportunity to: discover the immune response of different vulnerable and non-vulnerable populations (morning) and to learn more about how serosurveillance has been managed in other European countries and how to remain vigilant in the future (afternoon).

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Vaccination Vaccine Immune Response Antibody 52

Drug Discovery World

MAY 30, 2024

Dr Pollock is the Chief Investigator of the LEGACY03 clinical trial, a study aiming to investigate lymph nodes and vaccination responses across age groups. RA: Could you tell us about the LEGACY03 trial? It is these lymph nodes which help to make proteins called antibodies that protect from infection.

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Vaccination Vaccine Scientist Clinical Trials 59

The Pharma Data

DECEMBER 11, 2020

The University of Oxford has regularly appeared in our updates since July 2020, as its team of researchers leads an ongoing clinical trial for the Covid-19 vaccine. As we follow individuals over the course of a year, we are repeatedly testing them for both virus and antibodies.”.

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Scienmag

MAY 13, 2021

New study suggests COVID vaccines may still be helpful for patients with antibody deficiency disorders According to data from a cohort of adult and pediatric patients with antibody deficiencies, patients that often fail to make protective immune responses to infections and vaccinations showed robust T-cell activity and humoral immunity against SARS-CoV-2 (..)

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Immune Response Antibody Protein Vaccination 53

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis).

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Antibody Trials Production Clinical Trials 52

XTalks

MAY 24, 2024

Carbone, professor of internal medicine and director of the James Thoracic Oncology Center at the Ohio State University Medical Center, in a recent press release. Imdelltra is a novel immunotherapy, where a bispecific antibody binds to both CD3 on T cells and DLL3 on tumor cells. About 40 percent of patients saw significant shrinkage.

Antibody 52

Antibody Clinical Trials Clinical Trials Trials 52

Drug Discovery World

FEBRUARY 23, 2023

Covid-19 booster candidate UB-612 has achieved its immunogenicity endpoints in a head-to-head trial against three vaccine platforms: mRNA (Pfizer-BioNTech’s BNT162b2), adenovirus vector (AstraZeneca’s ChAdOx1-S), and inactivated virus (Sinopharm’s BIBP). 5 variants compared to adenovirus vector (ChAdOx1-S) and inactivated (BIBP) vaccines.

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Vaccination Vaccine Immune Response Antibody 52

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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The Pharma Data

DECEMBER 16, 2020

Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M to enhance the immune response. NVX-CoV2373 is being evaluated in an ongoing Phase 3 trial in the U.K. About NVX-CoV2373. and Australia.

Protein 52

Protein Vaccination Vaccine Immune Response 52

pharmaphorum

NOVEMBER 25, 2022

While the shot is still in preclinical development, if it works in human trials it could raise the prospect of eventually sidestepping the annual scramble to guess the most likely strains to be circulating in the following flu season, and protect against future flu pandemics. are not similar.”

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The Pharma Data

OCTOBER 14, 2020

a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, announced today that the U.S. APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. SAN CARLOS, Calif. , About Apexigen.

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Immune Response Drugs Antibody Clinical Trials 40

The Pharma Data

DECEMBER 23, 2020

Additionally, Phase 1 clinical data found INO-4800 to have a favorable safety and tolerability profile with no serious adverse events reported; only six Grade 1 adverse events (AEs) were observed, primarily minor injection site reactions. . ” Findings from the Phase 1 Clinical Trial.

DNA 40

DNA Vaccination Vaccine Immune Response 40

Delveinsight

AUGUST 26, 2021

The company then utilizes the de-identified records to improve the design of clinical trials and quality of life measurements. Now, Real Chemistry and Datavant are getting real with a plethora of data that the pair contemplates can help deliver on new gene therapies and precision medicines.

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The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., combined dose groups; 6.5%

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WCG Clinical

MAY 28, 2024

This proliferative capacity allows a rapid response to an incoming threat, such as a viral infection. T cells and B cells also express specialized antigen receptors that impart specificity to the immune response, directing immune attack against foreign “non-self” targets while sparing “self” targets expressed by healthy tissue.

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In-Vivo Clinical Trials Clinical Trials FDA Approval 52

pharmaphorum

DECEMBER 15, 2020

million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials. Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3.

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Bacteria Vaccination Vaccine Immune Response 52

The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2). i,ii,iii,iv.

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Antibody Vaccination Vaccine Trials 52