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. Additionally, personalized medicine tends to be more difficult to manufacture because of regulatory requirements beyond traditional drug manufacturing requirements.

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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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Drug Discovery World

SEPTEMBER 15, 2023

The trial, which marks the first time a human has been dosed with Replicate’s srRNA technology, will serve as a benchmark for utility in this indication and other complex infectious diseases and provide foundational insights to inform future clinical trials, most notably in oncology and autoimmune disease.

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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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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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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. About CEPI.

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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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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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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pharmaphorum

SEPTEMBER 15, 2020

Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand. Roche meanwhile is continuing to trial its drug in combination with remdesivir.

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Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. A 351(K) application must include information explaining that the biosimilarity is completely based on the data related to animal studies, clinical studies, and analytical studies.

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The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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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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XTalks

MARCH 19, 2024

These cells are crucial for the body’s immune response, producing antibodies that help fight infection. However, when these cells become cancerous, they proliferate uncontrollably, leading to a myriad of health issues, including bone damage, kidney failure and impaired immune function.

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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. and Australia. About Novavax.

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pharmaphorum

NOVEMBER 25, 2022

A universal flu vaccine could help avoid the variability in effectiveness seen with current seasonal jabs, which is generally around 60%, but can fall to as low as 10% if health authorities and manufacturers incorrectly guess the strains that end up spreading in the flu season. are not similar.”

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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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The Pharma Data

OCTOBER 26, 2020

Diagnostics Update : To-date the FDA has authorized 284 individual EUAs, which include 221 molecular tests, 56 antibody tests and 7 antigen tests. . Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located. Please read more here. .

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XTalks

FEBRUARY 27, 2024

Approximately 95 clinical trials evaluating TIL therapies have been registered globally. According to Iovance, Amtagvi is manufactured using a proprietary process to collect and expand a patient’s unique T cells from a portion of their tumor, and then returning billions of the patient’s T cells back to the body to fight their cancer.

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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. mg and 2.0

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XTalks

JULY 8, 2021

The drugs are monoclonal antibodies against the IL-6 receptor. Patients with severe COVID-19 often have an overactivation of the immune system, which involves the increased release of cytokines (cytokine release syndrome) such as IL-6. By blocking the cytokine from binding to its receptor, the hyperactive immune response can be tamed.

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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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The Pharma Data

SEPTEMBER 2, 2020

Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The randomised, double blind and placebo-controlled trial is designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the experimental COVID-19 vaccine candidate.

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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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XTalks

APRIL 26, 2021

Moreover, a very strong immune response is needed to fend off the disease. With the commitment by our commercial partner, the Serum Institute of India, to manufacture at least 200 million doses annually in the coming years, the vaccine has the potential to have major public health impact if licensure is achieved.”.

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The Pharma Data

NOVEMBER 30, 2020

We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”. pivotal Phase 3 trial update. Mexico pivotal Phase 3 trial update. United Kingdom (U.K.)

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The Pharma Data

DECEMBER 3, 2020

S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800.

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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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The Pharma Data

JANUARY 6, 2021

Quantitative imaging of CD8 T cells enables quicker identification of drug efficacy, therefore potentially reducing the length of clinical trials, reducing costs and helping new therapies to advance to market faster, which ultimately will improve treatment and care of cancer patients. No other terms were disclosed. ImaginAb Inc.

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The Pharma Data

MARCH 27, 2023

Entyvio ® should be used only in patients with inadequate response to conventional treatment. This approval is based on the MLN0002SC-3027 and MLN0002SC-3030 clinical trials, which are international Phase III trials to evaluate the efficacy and safety of Entyvio SC as a maintenance therapy.

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pharmaphorum

JANUARY 8, 2021

NICE has rejected Bristol Myers Squibb’s immunotherapy Opdivo as a second-line treatment for head and neck cancer in first draft guidance, unconvinced by evidence unearthed during a three-year NHS trial period. Opdivo is a monoclonal antibody that binds to the PD-1 receptor, blocking its interaction with the PD-L1 and PD-L2 proteins.

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The Pharma Data

FEBRUARY 22, 2021

New Phase 2 study assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults. Results of the Phase 2 trial will inform the Phase 3 protocol. If data from the new Phase 2 trial are positive, a global Phase 3 study is planned for Q2 2021.

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Delveinsight

FEBRUARY 11, 2021

Verily collaborates with Janssen to launch COVID-19 immune response study. Verily is partnering with Johnson & Johnson’s Janssen division to witness the body’s earliest immune responses to a coronavirus infection, with people participating in the research from within their homes. .

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XTalks

JULY 8, 2021

The drugs are monoclonal antibodies against the IL-6 receptor. Patients with severe COVID-19 often have an overactivation of the immune system, which involves the increased release of cytokines (cytokine release syndrome) such as IL-6. By blocking the cytokine from binding to its receptor, the hyperactive immune response can be tamed.

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The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. Vaccine doses for Europe would be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. billion doses by the end of 2021.

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The Pharma Data

SEPTEMBER 25, 2020

A trial of a new vaccine that appears to train the immune system to fight coronavirus has begun in the UK. Early tests showed the jab, developed by US biotechnology company Novavax, leads to high levels of virus-fighting antibodies being produced. ” The vaccine will be manufactured in Stockton-on-Tees.

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The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The goal of targeting both S and N was to both activate virus-specific T cells and generate anti-SARS-CoV-2-neutralizing antibodies. This press release features multimedia. Graphic: Business Wire).

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