XTalks

DECEMBER 29, 2023

Amgen recently reported that the US Food and Drug Administration (FDA) has given priority review status to its drug candidate, tarlatamab, intended for the treatment of small-cell lung cancer (SCLC). It targets delta-like ligand 3 (DLL3), a protein usually found inside normal cells but abnormally present on the surface of SCLC cells.

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Clinical Trials Clinical Trials FDA Approval Trials 119

Pharmaceutical Technology

AUGUST 18, 2022

New Zealand’s Medsafe has granted expanded provisional approval for Novavax ’s protein-based Covid-19 vaccine Nuvaxovid (NVX-CoV2373) as a heterologous and homologous booster dose in adults aged 18 years and above. The booster vaccine is indicated for active immunisation for the prevention of Covid-19 in people of this age group.

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Immune Response Vaccination Vaccine Protein 130

Drug Discovery World

MARCH 4, 2024

In an early phase clinical trial, a combination of antibody-based medications targeting the immune system generated promising safety data and anti-tumour activity in individuals with advanced cancer. Both medications tested in the trial support immune responses against tumour cells.

Antibody 115

Antibody Immune Response Trials Clinical Trials 115

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Clinical Trials Clinical Trials Vaccination Vaccine 76

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.

Protein 97

Protein Vaccination Vaccine Trials 97

Cloudbyz

MARCH 5, 2024

In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. Biologics: Biologics are large, complex molecules, often proteins, that are produced using living cells. The production process is often less complex compared to biologics.

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Development Drugs Manufacturing Immune Response 77

Drug Discovery World

FEBRUARY 19, 2024

Replicate Bioscience has shared positive results from the Phase I trial of RBI-4000, its srRNA-based rabies vaccine. In this clinical trial, evaluating safety and immunogenicity of RBI-4000 , participants received one or two doses of srRNA vaccine at low doses (0.1mcg, 1mcg or 10mcg).

Vaccination 52

Vaccination Vaccine Immune Response RNA 52

Drug Discovery World

AUGUST 3, 2023

Bimervax combines a part of the SARS-CoV-2 virus spike protein with an adjuvant. The clinical evidence for the authorisation is based on data from a study of 765 adults who had received primary vaccination with two doses of the Comirnaty Covid-19 vaccine and who were given a booster dose of either Bimervax or Comirnaty.

Vaccination 52

Vaccination Vaccine Immune Response Medicine 52

pharmaphorum

APRIL 8, 2022

Jazz Pharma has bolstered its pipeline of cancer drugs through a $1.3 The Dublin-based pharma is paying $15 million upfront for global rights to Werewolf’s WTX-613, a prodrug of the cytokine interferon alfa-2b, which is still back n preclinical development and due to start its first clinical trials next year.

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Drugs Immune Response Licensing Licensing 101

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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Vaccination Vaccine Protein Antibody 52

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration were based on mRNA, more conventional protein-based vaccines have also shown promise in clinical trials. Most train the immune system to recognize the RBD, a peptide that is the portion of the SARS-CoV-2 spike protein that binds to the ACE-2 receptor on host cell surfaces.

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Protein Vaccination Vaccine Antibody 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.

Protein 52

Protein Vaccination Vaccine Immune Response 52

pharmaphorum

SEPTEMBER 14, 2021

Repeat sequences aren’t involved in expressing proteins so have been generally under-studied by researchers, but there is increasing evidence that some human traits and diseases may be associated with mutations within them. Most drug discovery programmes target the roughly 2% of the human genome which encodes for protein.

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DNA Immune Response Genome Genomics 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

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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Vaccination Vaccine Trials Immune Response 98

The Pharma Data

APRIL 15, 2022

Food and Drug Administration in the coming days with additional submissions to other regulatory agencies worldwide to follow. About the Phase 1/2/3 Trial in Children. Additional children have been enrolled in all age groups following study amendments and the trial currently includes more than 10,000 children. Pfizer Inc.

Immune Response 52

Immune Response Vaccination Vaccine Clinical Trials 52

Camargo

JULY 27, 2021

When developing a clinical development program for these increasingly popular therapies, it is important that sponsors use modeling and pharmacokinetic (PK) analysis to evaluate parameters that can be measured while dosing with gene therapy drugs, to characterize exposure-response data and inform rational dosing.

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Gene Therapy Gene Gene Editing Genetics 238

XTalks

NOVEMBER 30, 2023

In 2022, the US Food and Drug Administration (FDA) granted approval to the medication Sunlenca (lenacapavir) for adults living with multi-drug resistant HIV-1 infection. Developed by Gilead, Sunlenca is the first drug in a novel class known as capsid inhibitors to receive FDA approval for treating HIV-1.

FDA Approval 111

FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

Drug Discovery World

SEPTEMBER 25, 2023

The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and will evaluate the investigational vaccine for safety and its ability to elicit an immune response. “An The vaccine produced robust antibody responses in animal testing.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

XTalks

JUNE 15, 2022

Last week, Novavax announced that it received positive feedback from the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) regarding the safety and efficacy of its COVID-9 vaccine (NVX-CoV2373). protein that triggers the immune system to generate antibodies against the virus.

Vaccination 59

Vaccination Vaccine Immune Response Protein 59

pharmaphorum

JANUARY 10, 2023

Since then, the two partners have developed multiple AI-based applications including a platform for selecting neoantigens for use in individualised cancer vaccines and an early warning system for high risk SARS-CoV-2 variants based on how well they can evade the immune system and their transmissibility.

Vaccination 116

Vaccination Vaccine Clinical Trials Clinical Trials 116

XTalks

AUGUST 8, 2022

The acquisition will allow Gilead to have MiroBio’s proprietary discovery platform and their pipeline of immune checkpoint agonists. MiroBio currently has four different potential drug candidates and multiple early-stage assets in the research phase. PD-1 is a potent immune inhibitory receptor.

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Immune Response Antibody Life Science Engineer 98

STAT News

MARCH 6, 2023

Unlike most people who receive medications yet to be cleared by the Food and Drug Administration, none of these patients is getting the vaccines as part of a clinical trial. Neoantigen vaccines are designed to target certain proteins called neoantigens on tumor cells.

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Vaccination Vaccine Drugs Clinical Trials 98

pharmaphorum

FEBRUARY 9, 2022

Closely related to this is the fact that global spending on oncology drugs reached $164 billion in 2020, with drug sales growing at a compound annual growth rate of 14.3% While therapeutic cancer vaccines are able to help the body identify particular proteins expressed by cancer cells and then to instigate an immune response.

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Vaccination Vaccine Clinical Trials Clinical Trials 132

Drug Discovery World

JULY 5, 2023

For example, if a patient’s tumour has a particular protein present, called a checkpoint protein, this will reduce the response of T-cells. Of course, if a patient’s tumour does not have this protein, then this type of treatment won’t be effective. Biography Mark Garner received his Ph.D. The Lancet 2022.

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Research Protein Scientist Immune Response 98

The Pharma Data

SEPTEMBER 14, 2020

AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). The move follows a green light by the UK's MHRA. Source link.

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Vaccination Vaccine Trials Immune Response 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

pharmaphorum

JULY 20, 2021

The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. The phase 3 trial being run in support of approval is using a two-shot regimen, with the first dose targeting the original SARS-CoV-2 virus and the second targeting beta (B.1.351)

Vaccination 98

Vaccination Vaccine Protein Immune Response 98

Delveinsight

JANUARY 21, 2021

Drugs that target the cancer-promoting proteins MDM2 and BET have been attempted in acute myeloid leukaemia (AML) and have not been all that effective on their own. The combination appears to work by activation of the tumour-suppressing protein p53, they announced. billion in total for three drugs. Jacob Van Naarden, M.D.,

Research 52

Research Protein Clinical Trials Clinical Trials 52

pharmaphorum

JANUARY 26, 2022

The FDA has placed a partial clinical fold on clinical trials of Gilead Sciences’ magrolimab, the centre piece of its $4.9 Other studies of the CD47-directed antibody in large B cell lymphoma, multiple myeloma and solid tumours are not affected as they don’t include azacitidine as a study drug.

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Trials Drugs Immune Response Antibody 40

pharmaphorum

NOVEMBER 25, 2021

A vaccine delivered by subcutaneous injection targeting tau – a protein which forms tangles that are another feature observed in AD brains – is also being studied by drugmaker Johnson & Johnson in partnership with AC Immune in a phase 1 study. Its main objective is gauging the safety and tolerability of the vaccine.

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Vaccination Vaccine Trials Immune Response 94

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. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant. and globally.”.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. Given the success of Oxford’s Phase II trial, the study investigators are now gearing up for a Phase III licensure trial to assess large-scale safety and efficacy in 4,800 children aged 5 to 36 months across four countries in Africa. Malaria Vaccine Phase II Trial.

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Vaccination Vaccine Immune Response Trials 105

The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. Clover intends to initiate a separate pivotal clinical trial of the S-Trimer vaccine candidate in combination with Dynavax’s advanced CpG 1018 adjuvant plus alum in the first half of 2021.

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Vaccination Vaccine Immune Response Protein 52

XTalks

JUNE 18, 2021

This is why Regeneron’s announcement of positive clinical trial results that show its antibody cocktail treatment can cut deaths among hospitalized patients is welcome news. It is the first trial to demonstrate that any antibody treatment could improve survival in patients hospitalized with COVID-19.

Antibody 75

Antibody Immune Response Trials Clinical Trials 75

Delveinsight

AUGUST 26, 2021

Shape’s RNA editing technologies can modify the RNA sequence, which makes the body’s protein building blocks. Shape’s RNA editing technology could potentially modify the amount of a key regulatory protein in the body or treat genetic diseases. Datavant inks real-world data partnership with Real Chemistry.

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Vaccination Vaccine Gene Therapy RNA 98

XTalks

FEBRUARY 29, 2024

Dual-function fusion proteins represent a cutting-edge approach in biopharmaceutical research, offering a promising avenue for the development of novel therapeutics in the treatment of complex diseases such as cancer and autoimmune disorders. At the helm of this venture is Dr. Taylor H. How is your lead program differentiated?

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Protein Development Clinical Trials Clinical Trials 94