Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Bivalent vaccines work by stimulating an immune response against two different antigens, whereas monovalent vaccines only target one antigen. 1 sub-lineage on 19 July.

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Manufacturing Vaccine Vaccination Packaging 130

pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. In animal models, neutralising DKK1 has been shown to activate an innate immune response against malignant cells.

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Immune Response Trials Drugs Containment 72

pharmaphorum

AUGUST 16, 2020

The advance order will be financed using the EU’s Emergency Support Instrument, a €2 billion fund set aside to cover purchases of vaccines, drugs and other goods needed to fight the coronavirus epidemic.

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Vaccine Vaccination Immune Response Trials 111

pharmaphorum

SEPTEMBER 14, 2021

The Cambridge, Massachusetts biotech is focusing specifically on the 60% of DNA sequences that repeat themselves hundreds or thousands of times in the genome, known as the ‘repeatome’, that could contain targets for cancer and autoimmune disorders.

DNA 52

DNA Immune Response Genome Genomics 52

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. Children have been the focus of malaria vaccine and drug trials because over 90 percent of deaths attributable to malaria are in African children under the age of five. Moreover, a very strong immune response is needed to fend off the disease.

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Vaccine Vaccination Immune Response Trials 105

pharmaphorum

APRIL 26, 2022

As more research has been conducted, closer and unexpected links have been found between the microbiome of the gut, as one example, and other areas of the body, such as brain health and the immune system. Finch Therapeutics, which is partnered with Takeda on several drug candidates, is developing FIN-211 for autism spectrum disorder (ASD).

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Containment Development Production Drugs 115

XTalks

MAY 4, 2023

When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food. As of now, the US Food and Drug Administration (FDA) has not approved any drugs for the treatment of celiac disease.

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Clinical Trials Clinical Trials Trials Immune Response 98

STAT News

NOVEMBER 3, 2022

The companies allege Moderna’s vaccine uses their technology for a drug-delivery system without permission. Citing The early-stage study, which is being sponsored by BioNTech, aims to evaluate safety, tolerability, and immunogenicity, or the ability to generate an immune response.

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Vaccine Vaccination Drug Delivery Systems Sales 97

Pharmaceutical Technology

AUGUST 24, 2022

A central lab with a global footprint provides both the efficient transportation arrangement and scientific rigor required to unlock the valuable information contained within patients’ biological samples. The data are used for decision-making during drug development (purpose). Flow cytometry in biomarker research.

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Clinical Trials Clinical Trials Trials Development 130

Delveinsight

JANUARY 22, 2021

The launch of a novel drug in the market is not less than a celebration in the pharmaceutical and healthcare market; however, it also brings the real challenge of sustenance in the market. Similar is the picture of the Thrombocytopenia Drugs Market. Drug-Induced Thrombocytopenia, Gian Paolo Visentin, Chao Yan Liu).

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Marketing Drugs Antibody Compliance 65

XTalks

DECEMBER 20, 2021

The company is awaiting on authorization of its vaccine from regulatory health bodies around the world, including the US Food and Drug Administration (FDA) and Health Canada. It contains Novavax’s Matrix-M adjuvant to enhance the immune response.

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Vaccine Vaccination Protein Manufacturing 96

The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

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Drugs Clinical Trials Clinical Trials Containment 52

XTalks

MAY 7, 2021

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 1.351 variant.

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Protein Vaccine Vaccination Trials 97

The Pharma Data

SEPTEMBER 14, 2020

The drug giant said that it could not disclose further medical information but that all trial investigators and participants will be updated with the relevant information. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

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Vaccine Vaccination Trials Immune Response 52

The Pharma Data

JULY 18, 2021

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.

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Immune Response Vaccine Vaccination FDA Approval 52

The Pharma Data

APRIL 8, 2022

Now, new research from the Wyss Institute at Harvard University has revealed that this constant pattern of stretching and relaxing does even more – it generates immune responses against invading viruses. a Wyss Technology Development Fellow at the Institute. ” The results are published today in Nature Communications.

Immune Response 52

Immune Response In-Vivo Genetic Analysis Research 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. The VAERS toll-free number is 1?800?822?7967

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Vaccine Vaccination Protein Immune Response 111

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.

Protein 52

Protein Vaccine Vaccination Immune Response 52

XTalks

AUGUST 17, 2020

chimeric receptor antigen [CAR] T cell) immune modulators (i.e. Immune checkpoint inhibitors : these are drugs that block immune checkpoints, allowing immune cells to elicit enhanced responses to cancer cells. Treatment vaccines : these boost the immune system responses to target cells.

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Protein Engineer Immune Response In-Vivo 98

XTalks

SEPTEMBER 15, 2020

In addition to the vaccine, the company is also developing an investigational drug called Remygen for the regeneration of endogenous insulin production and to improve hormonal response to hypoglycemia; trials to test the treatment are currently ongoing in patients that have been living with type 1 diabetes for more than five years.

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Vaccine Vaccination Insulin Trials 103

XTalks

MAY 1, 2023

Last week, the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 ( SOD1 ) gene. This makes Qalsody the first approved treatment to target a genetic cause of ALS.

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FDA Approval Gene Genetics Protein 89

The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. GAITHERSBURG, Md., 09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. About Fast Track Designation.

Vaccine 52

Vaccine Vaccination Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 15, 2021

Now, researchers reporting in ACS Central Science have immunized mice with nanoparticles that mimic SARS-CoV-2 by displaying multiple copies of the receptor binding domain (RBD) antigen, showing that the vaccine triggers robust antibody and T cell responses. Although the first vaccines to receive Emergency Use Authorization by the U.S.

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Protein Vaccine Vaccination Antibody 52

Roots Analysis

JANUARY 6, 2022

Myeloid cells represent a group of cells containing granulocytes, monocytes, macrophages, mast cells and dendritic cells, which play a key role in innate immunity. Over time, many research studies have shown that myeloid cells can interact with the immune system and aid in generating an appropriate anti-tumor immune response.

Immune Response 52

Immune Response Clinical Trials Clinical Trials Marketing 52

Roots Analysis

FEBRUARY 18, 2022

Myeloid cells represent a group of cells containing granulocytes, monocytes, macrophages, mast cells and dendritic cells, which play a key role in innate immunity. Over time, many research studies have shown that myeloid cells can interact with the immune system and aid in generating an appropriate anti-tumor immune response.

Drug Delivery Systems 52

Drug Delivery Systems Immune Response Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 13, 2020

SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic Biotic designed to activate the STING pathway in the tumor microenvironment in order to upregulate the patient’s immune response. CAMBRIDGE, Mass. , Sokolovska, A.,

Immune Response 40

Immune Response Engineer Medicine Clinical Trials 40

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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Vaccine Vaccination Immune Response Containment 52

The Pharma Data

MARCH 8, 2021

inhibition,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer at Novartis. Pro-tumor inflammation enables tumor development by driving cancer-causing processes and by suppressing anti-tumor immune responses 9,10. Canakinumab is a first-in-class interleukin-1beta (IL-1?) Disclaimer.

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Trials Immune Response Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 9, 2020

Combining ICIs with radiation therapy is emerging as a valuable strategy to “prime” an immune response and thereby increase the response rate, however the efficacy of radiation therapy is limited by toxicities related to the exposure of healthy tissues. NBTXR3 is injected one time, directly into solid tumors.

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Immune Response Containment Trials Clinical Trials 40

Pfizer

FEBRUARY 16, 2023

Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025, pending successful completion of the Phase 3 studies and subject to the agreement of these regulatory agencies to proposed modifications of the clinical trial plan.

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Clinical Trials Clinical Trials Vaccine Vaccination 76

The Pharma Data

JUNE 24, 2021

Secondary objectives are to describe immune responses produced by each of the vaccines. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. The Pfizer?BioNTech

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Vaccine Vaccination Immune Response Licensing 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. Forward-Looking Statements.

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Vaccine Vaccination Immune Response Protein 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

The Pharma Data

OCTOBER 21, 2020

Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-001, an allogeneic gamma delta (??) We believe that ADI-001 offers the opportunity for on demand treatment, selective tumor targeting, innate and adaptive anti-tumor immune response, and durable activity in patients.

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Immune Response Engineer Clinical Trials Clinical Trials 40

The Pharma Data

APRIL 22, 2023

These “acute inflammatory lesions” then attract other myeloid cells, as well as self-reactive T and B cells that belong to the immune system’s second arm, known as the “adaptive immune system” and directly attack the myelin covering. “Current MS therapies do not specifically target myeloid cells. .

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Immune Response Engineer In-Vivo Containment 40

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. TICOVAC may help reduce the risk of TBE for people traveling to endemic areas, potentially including military personnel serving in these locations.

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FDA Approval Vaccine Vaccination Containment 52

The Pharma Data

NOVEMBER 30, 2020

Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA). NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Additional clinical data from the Phase 2 trial conducted in the U.S.

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Clinical Development Vaccine Vaccination Development 52