Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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Development Production Immune Response Licensing 161

XTalks

NOVEMBER 6, 2020

We are exceptionally pleased to commence dosing of our oral DNA vaccine for COVID-19 as we continue scale-up and manufacturing activities for future clinical development,” Symvivo’s chief medical officer Eric Sievers said in a press release from the company. Related: Red Meat Allergy Test Gets FDA Clearance. “We

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Clinical Trials Clinical Trials Vaccination Vaccine 75

Cloudbyz

MARCH 5, 2024

Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability. The conditions affecting the living system can influence the final product, making the manufacturing process more sensitive and challenging.

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Development Drugs Immune Response Manufacturing 97

pharmaphorum

FEBRUARY 8, 2021

It works by using inactivated viral particles to expose the immune system, which mounts an immune response that fights off the active virus in the event of an infection. Initially, researchers from the Butantan Institute which conducted trials in Brazil, said the vaccine showed 78% efficacy against mild-to-severe COVID-19 cases.

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Vaccination Vaccine Immune Response Regulation 90

pharmaphorum

JULY 13, 2022

Bicycle’s bicyclic peptide drug discovery platform is designed to produce drug candidates that have targeting properties like antibodies but are much smaller molecules, making manufacturing and dosing easier. Genentech has been looking at the platform since 2020 under the terms of a deal worth up to $1.7

Immune Response 105

Immune Response Drugs Antibody Manufacturing 105

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.

Drugs 97

Drugs Antibody Contract Manufacturing Immune Response 97

pharmaphorum

OCTOBER 2, 2020

Genentech, which is already well established as a player in cancer immunotherapy with its PD-L1 class drug Tecentriq (atezolizumab) , will be responsible for development and marketing thereafter. The Roche unit will also bear all costs for trials, filings, manufacturing and marketing after the completion of the phase 1b study.

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Vaccination Vaccine Immune Response Drugs 59

Worldwide Clinical Trials

JUNE 15, 2022

Consulting with regulatory experts and experts in toxicology, manufacturing, etc., We’ve also seen a decrease in available research nurses, as they have had to be reassigned to COVID patients. Most holds are being lifted, especially for oncology and hematology, but neurology holds are seeming to stick around longer 1.

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Gene Therapy Gene Clinical Trials Clinical Trials 130

The Pharma Data

DECEMBER 20, 2020

In October, Scancell signed a manufacturing deal for SN14 with Cobra Biologics, a Cognate BioServices subsidiary, ahead of a planned phase 1 trial in 2021. SN14 works by targeting the coronavirus’ nucleocapsid and spike proteins to prevent viral replication using the company’s ImmunoBody DNA vaccine technology. Source link.

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Clinical Trials Clinical Trials Pharma Companies Vaccination 52

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level.

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Vaccination Vaccine Protein Immune Response 111

pharmaphorum

SEPTEMBER 15, 2020

The UK has also agreed to invest in Valneva’s manufacturing plant in Livingston, Scotland, to help scale up production of the vaccine, with the investment serving as a credit for future vaccine supply. The hope is that directly targeting the cells lining the airways may stimulate a more effective immune response against SARS-CoV-2.

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Vaccination Vaccine Immune Response Manufacturing 80

The Pharma Data

SEPTEMBER 4, 2020

The data, published in Nature Medicine, show that the investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by neutralising antibodies and prevented severe clinical disease, including weight loss, pneumonia and mortality, the firm said. End of the line for pimodivir in flu. .

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Vaccination Vaccine Immune Response Antibody 52

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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Vaccination Vaccine Manufacturing Clinical Trials 52

XTalks

NOVEMBER 23, 2020

Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials. As a manufacturing partner for Oxford’s vaccine, AstraZeneca is ramping up its production capabilities as it plans to make up to three billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval.

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Vaccination Vaccine Clinical Trials Clinical Trials 97

XTalks

SEPTEMBER 5, 2023

With over two decades of experience in vaccine research, Boceta-Muñoz has experience across all clinical development phases in a range of therapeutic areas. Finally, addressing the time-consuming and costly transition from non-clinical to clinical development due to difficulties in predicting human immune responses is another issue.

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Vaccination Vaccine Development Clinical Trials 96

The Pharma Data

SEPTEMBER 2, 2020

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. Source link.

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Vaccination Vaccine Trials Immune Response 52

XTalks

NOVEMBER 10, 2020

Interim results of the trial show that all participants developed an antibody response after two doses of the COVID-19 adjuvanted vaccine candidate. Adjuvants are used to help stimulate stronger vaccine immune responses. These are very promising results. Plant-Based Vaccine Technology.

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Vaccination Vaccine Trials Immune Response 52

The Pharma Data

SEPTEMBER 25, 2020

The data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants aged 18 years and older and was generally well-tolerated. Immune responses were similar across the age groups studied, including older adults. Immune Response Data.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

SEPTEMBER 3, 2020

The data, published today in Nature Medicine , demonstrated that the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by “neutralizing antibodies” and prevented severe clinical disease – including weight loss, pneumonia and mortality – in Syrian golden hamsters upon challenge.

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Vaccination Vaccine Immune Response Antibody 52

The Pharma Data

SEPTEMBER 30, 2021

Our results show that the candidate vaccine formulation is safe, produces rapid immune responses – within seven days – and elicits comprehensive immunity against SARS-CoV-2,” said Varadarajan. A fundamental limitation of intramuscular vaccines is that they’re not designed to elicit mucosal immunity.

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Vaccination Vaccine Immune Response Licensing 52

XTalks

FEBRUARY 3, 2021

The new vaccine technology (mRNA) has been in research since 2005, but in trials on cancer cells. However, during the pandemic, the research has been shifted to using this platform to manufacture the COVID-19 vaccine. Herd Immunity and Equitable Access to COVID-19 Vaccines.

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Vaccination Vaccine Immune Response Manufacturing 98

The Pharma Data

NOVEMBER 15, 2020

Clover aims to double its commercial manufacturing capacity in preparation for global Phase 2/3 trials. Cytiva provides FlexFactory bioprocessing upstream and downstream solutions for Clover to accelerate GMP facility development and shorten time to market. SHANGHAI , Nov. SHANGHAI , Nov.

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Vaccination Vaccine Manufacturing Life Science 52

The Pharma Data

MAY 17, 2021

Sanofi and GlaxoSmithKline (GSK) have reemerged as COVID-19 vaccine contenders after their reformulated candidate delivered a strong immune response across all age groups in a phase 2 study. 14, 2020 ). Although wealthy territories like the U.S.,

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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. More recently, the university has released news of its collaboration with Thermo Fisher Scientific as it looks to discover an immune Covid-19 response pre- and post-vaccination.

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Antibody Vaccination Vaccine Containment 52

The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. We are encouraged by the high level of neutralizing antibodies in combination with the strong Th1 response which we believe could play an important role in controlling infection.

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Vaccination Vaccine Immune Response Protein 52

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. government in order to accelerate its development and manufacturing. GSK will also support manufacturing of up to 100m doses of CureVac’s first generation COVID-19 vaccine, if approved.

Protein 52

Protein Vaccination Vaccine Immune Response 52

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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Gene Therapy Gene Immune Response In-Vivo 52

The Pharma Data

JUNE 26, 2021

We’ve all witnessed the promise of mRNA technology during this pandemic and are now looking to extend that promise to select annual vaccines ”, said Jean-François Toussaint, Global Head of Research and Development, Sanofi Pasteur. “ The trial follows successful preclinical research which demonstrated promising safety and immunogenicity.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

JANUARY 18, 2021

Next Generation AAVs enhance gene therapies by increasing transduction efficiency and specificity while reducing immune responses and cost. Major challenges in AAV-based gene therapy are the transduction efficiency, possible immunity to the capsid and complex manufacturing processes. About Neurophth.

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Gene Therapy Gene Immune Response Manufacturing 52

The Pharma Data

OCTOBER 25, 2020

In parallel we are scaling up our manufacturing capability with our strategic partners, Lonza and Rovi, to address this global health emergency by delivering a safe and effective vaccine to the people of Qatar and around the world.”. as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. About Moderna.

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Vaccination Vaccine Manufacturing Clinical Development 52

The Pharma Data

DECEMBER 23, 2020

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800. Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800. ClinicalTrials.gov identifier: NCT04336410.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. This collaboration brings together Sanofi Pasteur’s leadership in vaccines and Translate Bio’s mRNA research and development expertise.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

APRIL 3, 2021

Global Head, Janssen Research & Development, Johnson & Johnson. “In Research and development activities for the Company’s COVID-19 vaccine, including the delivery of doses to the U.S., Research and development activities for the Company’s COVID-19 vaccine, including the delivery of doses to the U.S.,

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Clinical Trials Clinical Trials Vaccination Vaccine 52

Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 1 as compared to the companies’ current COVID-19 vaccine.

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The Pharma Data

NOVEMBER 27, 2020

Field said: “Right now, everybody is talking about a vaccine for coronavirus but vaccine development, validation, safety-testing, manufacture, regulatory approval and deployment is a time-consuming process. When speed-to-market is so critical, research collaboration is key to ensuring value is maintained throughout the product lifecycle.

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Vaccination Vaccine Immune Response Marketing 52

Roots Analysis

MARCH 3, 2022

The complement-targeted therapeutics inhibit complement activation, thereby reducing tissue inflammation and dampening the adaptive immune response to foreign and tissue antigens. Published Scientific Literature: Indicative of the Ongoing pace of Research in this Field. Next Generation Complement Therapeutics. Web: [link].

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Drug Delivery Systems Marketing Immune Response Dermatology 52

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.”. and Mexico pivotal Phase 3 trial and manufacturing scale-up. . Mexico pivotal Phase 3 trial update.

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Clinical Development Vaccination Vaccine Development 52