pharmaphorum

AUGUST 23, 2021

Ahmedabad-based Zydus Cadila has said it expects to launch ZyCoV-D in late September or early October, and expects to be able to manufacture around 100-120 million doses a year, with around 10 million available at launch. Proponents of the approach claim that DNA vaccines may have advantages over other technologies like mRNA.

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XTalks

DECEMBER 14, 2021

Moderna revealed the first interim results from a small, Phase I study of its mRNA-based influenza vaccine, which showed that the vaccine had no significant safety concerns and elicited immune responses against four strains of the influenza virus. There were no significant safety findings reported through day 29. Mixed Results.

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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. Pfizer Disclosure Notice.

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Worldwide Clinical Trials

JUNE 15, 2022

Consulting with regulatory experts and experts in toxicology, manufacturing, etc., There have been a few cases lately where patients receiving gene therapy had a severe adverse effect because of their immune response to the mechanism of the AAV viral vector, based on their own genomic markers.

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Gene Therapy Gene Clinical Trials Clinical Trials 130

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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Vaccine Vaccination Clinical Trials Clinical Trials 97

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 11, 2020

Thermo Fisher joined forces with the University of Oxford to harness its academic research capabilities in quantifying IgG antibodies and understanding each patient’s immune response to SARS-CoV-2. Sensitech technology helps to ensure the container refrigeration units can deliver a temperature control within +/- 0.25-degrees

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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 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. About Novavax.

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Protein Vaccine Vaccination 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 Vaccine Vaccination 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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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.”. On Thursday, October 22, Moderna completed enrollment of the Phase 3 COVE study. About Moderna.

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Vaccine Vaccination Manufacturing Clinical Development 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 The information contained in this release is as of July 19, 2022.

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Vaccine Vaccination Medicine Clinical Trials 100

Pfizer

FEBRUARY 16, 2023

VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

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Pfizer

JULY 8, 2022

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. The information contained in this release is as of July 8, 2022. Pfizer Disclosure Notice.

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FDA Approval Vaccine Vaccination Clinical Trials 102

The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. About Pneumococcal Disease.

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

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Clinical Development Vaccine Vaccination Development 52

Pfizer

JULY 8, 2022

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA).

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The Pharma Data

JUNE 26, 2021

“We believe that mRNA technology could have several advantages for a seasonal flu application including the potential ability to demonstrate robust immune responses based on preclinical data to date, enable antigen specificity within a short timeframe from seasonal virus strain selection, and deploy agile manufacturing capacity.

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Clinical Trials Clinical Trials Vaccine Vaccination 52

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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Vaccine Vaccination Clinical Trials Clinical Trials 52

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 study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. and its affiliate NantKwest, Inc.

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The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? Pfizer Disclosure Notice.

Vaccine 52

Vaccine Vaccination RNA Clinical Trials 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

DECEMBER 11, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. Manufacturing and Delivery Capabilities. Germany, Turkey, South Africa, Brazil and Argentina. Pfizer is leveraging three of its U.S.

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The Pharma Data

AUGUST 20, 2020

T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. trial and we look forward to sharing T cell immune response data from the German trial in the near future.”. “It View the full release here: [link].

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Vaccine Vaccination Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 31, 2021

Clover’s S-Trimer antigen adjuvanted with CpG 1018 plus alum demonstrated low reactogenicity while providing high levels of neutralizing antibodies and a strong Th1-biased cell-mediated immune response. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B.

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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

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The Pharma Data

NOVEMBER 14, 2020

The interim analysis showed that a single dose of the COVID-19 vaccine candidate induced a robust immune response and was generally well-tolerated. PHASE 3 ENSEMBLE 2 STUDY. JANSSEN’S INVESTIGATIONAL COVID-19 VACCINE CANDIDATE. Notice to Investors Concerning Forward-Looking Statements.

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The Pharma Data

JUNE 25, 2021

.” The company intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

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The Pharma Data

MAY 6, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of May 6, 2021. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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Vaccine Vaccination Clinical Trials Clinical Trials 52

The Pharma Data

OCTOBER 27, 2020

Sitravatinib is an investigational spectrum-selective inhibitor of receptor tyrosine kinases (RTK) designed to enhance immune responses through the inhibition of immunosuppressive signaling. This press release contains forward-looking statements within the meaning of the U.S. Forward-Looking Statements.

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Sales Immune Response Clinical Development Development 52

The Pharma Data

APRIL 22, 2023

“This means that vaccine manufacturers will have to keep creating new vaccines that target new variants, and people have to keep getting these new vaccines,” he said. These epitopes elicit an immune response from a broad selection of T cells, ensuring a sustained coverage of future variants.

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The Pharma Data

JANUARY 31, 2021

Delivery of viral antigens in potent vaccine vectors to elicit a strong immune response is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone. Gritstone Forward-Looking Statements.

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The Pharma Data

DECEMBER 27, 2020

Our work began modestly, but we hit our stride in 2020 and reached important clinical, manufacturing, and business milestones this year, which created substantial value and advanced us toward our ultimate goal. Our goal of building Lineage into the preeminent cell therapy company is ambitious but attainable.

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The Pharma Data

NOVEMBER 9, 2020

AstraZeneca continues to lead development and Amgen continues to lead manufacturing. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. All aspects of the collaboration are under the oversight of joint governing bodies.

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Trials Production Sales Manufacturing 52

The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. and Roche will develop, manufacture and distribute it outside the U.S. Yancopoulos , M.D., combined dose groups; 6.5%

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The Pharma Data

OCTOBER 21, 2020

Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released. About Replimune Replimune Group, Inc.,

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The Pharma Data

DECEMBER 17, 2020

The development and manufacturing of the antibody cocktail has been funded in part with federal funds from BARDA under OT number: HHSO100201700020C. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

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