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 64

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

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

Drug Discovery World

NOVEMBER 4, 2022

Instead, infection is either eliminated or contained by the infected individual. The post Study insights may aid TB vaccine development appeared first on Drug Discovery World (DDW). However, their previously identified correlates of risk of TB disease were not associated with an increased risk of M.tb

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Vaccination Vaccine Development Bacteria 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

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 Vaccination Vaccine FDA Approval 52

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. .

Drugs 52

Drugs Clinical Trials Clinical Trials Containment 52

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

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.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

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 Vaccination Vaccine Immune Response 52

Drug Discovery World

MARCH 16, 2023

In the study, funded by Cancer Research UK and published in Nature , the mice fed diets containing high doses of sucralose were less able to activate T cells in response to cancer or infection. No effect was seen on other types of immune cells.

Doctors 90

Doctors Doctor Containment Scientist 90

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.

Vaccination 105

Vaccination Vaccine 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 Immune Response 113

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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Vaccination Vaccine Immune Response Trials 111

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.

Protein 52

Protein Vaccination Vaccine Antibody 52

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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Vaccination Vaccine Manufacturing Protein 96

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

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

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. .

Immune Response 40

Immune Response Engineer In-Vivo Containment 40

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 Clinical Trials Clinical Trials 40

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Drug Discovery World

OCTOBER 21, 2022

The last month has seen a number of leaps in our understanding of difficult to treat and treatment resistant breast cancers, so here are Drug Discovery World’s top 5 research breakthroughs. A new drug target was identified for triple-negative breast cancer, a very difficult to treat type of breast cancer that mostly affects younger women.

In-Vivo 52

In-Vivo Research Drugs Engineer 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 Vaccination Vaccine Trials 97

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.

Immune Response 40

Immune Response Containment Trials 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.

Vaccination 52

Vaccination Vaccine 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.

Trials 52

Trials Immune Response Clinical Trials Clinical Trials 52

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.

Immune Response 40

Immune Response Engineer Clinical Trials Clinical Trials 40

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.

Protein 98

Protein Engineer Immune Response In-Vivo 98

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

Vaccination 52

Vaccination Vaccine Immune Response Licensing 52

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.

FDA Approval 52

FDA Approval Vaccination Vaccine Licensing 52

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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Vaccination Vaccine Insulin Trials 103

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.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

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 Vaccination Vaccine 76

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 Vaccination Vaccine Development 52

The Pharma Data

OCTOBER 25, 2020

The Phase 1 interim analysis showed that mRNA-1273 was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2. mRNA-1273 is currently being studied in a Phase 3 randomized, 1:1 placebo-controlled trial of 30,000 participants at the 100 µg dose level in the U.S.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Development 52

pharmaphorum

SEPTEMBER 2, 2021

Anna Biosciences’ Dr Anthony Rullo discusses the drug development company’s immunotherapy platform. Block C encodes our proprietary covalent chemical binding group that uniquely enhances and enforces CIR contact with the immune component. Overarching advantages related to patients, providers and production. Diverse disease indications.

Antibody 52

Antibody Protein Immune Response Vaccination 52

The Pharma Data

OCTOBER 19, 2020

The physical and universal mode of action (MoA) of NBTXR3 is designed to trigger cellular destruction death and adaptive immune response. This press release contains certain forward-looking statements concerning Nanobiotix and its business, including its prospects and product candidate development. Disclaimer.

Containment 52

Containment Clinical Trials Clinical Trials Immune Response 52