pharmaphorum

SEPTEMBER 1, 2020

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

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XTalks

JUNE 15, 2022

The Novavax candidate NVX-CoV2373 is a protein-based vaccine developed using recombinant nanoparticle technology. protein that triggers the immune system to generate antibodies against the virus. Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response. Clinical Trial Results.

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The Pharma Data

APRIL 15, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-µg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. About the Phase 1/2/3 Trial in Children. Pfizer Inc.

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pharmaphorum

MARCH 3, 2021

The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation. It cannot replicate or cause the disease but does produce a strong immune response that neutralises the virus in the event of an infection.

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XTalks

NOVEMBER 10, 2020

Update (November 11, 2020): Quebec-based biopharmaceutical company Medicago has announced positive results from a Phase I trial of its candidate plant-derived vaccine. Interim results of the trial show that all participants developed an antibody response after two doses of the COVID-19 adjuvanted vaccine candidate.

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XTalks

JUNE 9, 2022

What happens when the liver is unable to process bad cholesterol due to genetic factors? It is one of the common genetic causes of premature coronary heart disease. Doortje Reijman, trial investigator and research associate in Pediatric Metabolic Diseases and Nephrology at the Amsterdam University Medical Center.

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XTalks

NOVEMBER 30, 2023

Its mechanism of action involves blocking the protein shell (capsid) of the HIV-1 virus, disrupting multiple crucial stages of the viral lifecycle. Both trials concluded with maintained virologic suppression, and no clinically significant change from baseline in CD4+ cell counts was observed. In addition, Vir Biotechnology, Inc.

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XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. IGF-1 is an acceptable surrogate endpoint in trials of growth hormone receptor agonists like Somavert, and is preferred for pediatric patient populations.

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XTalks

MAY 1, 2023

This makes Qalsody the first approved treatment to target a genetic cause of ALS. Since SOD1 mutations were first identified as a cause of ALS 30 years ago, the familial ALS community has been searching for genetically targeted treatments. To date, over 200 mutations in the SOD1 gene have been associated with the development of ALS.

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XTalks

SEPTEMBER 15, 2020

A vaccine developed by Swedish company Diamyd Medical has demonstrated significant treatment efficacy in a predefined genetic subgroup of individuals with type 1 diabetes in a Phase IIb clinical trial. In the trial, the vaccine was injected directly into the lymph nodes of type 1 diabetic individuals. cells of the pancreas.

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XTalks

JUNE 5, 2023

Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains. “A The genetic material of RSV (respiratory syncytial virus) encodes 11 proteins. The F-protein facilitates the fusion of the virus with the membrane of the host cell. How Does Abrysvo Work?

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Cloudbyz

MARCH 5, 2024

Biologics: Biologics are large, complex molecules, often proteins, that are produced using living cells. Mode of Action : Small Molecules: They often work by binding to specific sites on target proteins to inhibit or activate their function, which can affect various biological pathways inside the cell.

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Drug Discovery World

SEPTEMBER 9, 2022

A new genetically engineered herpes virus has delivered a one-two punch against advanced cancers in initial findings from a Phase I trial. Patients on the trial had cancers including skin, oesophageal and head and neck cancer and had exhausted other treatments, including by failing to respond to checkpoint inhibitor immunotherapy.

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XTalks

NOVEMBER 23, 2020

Severe cases of the infection did not occur among trial participants, nor were any hospitalizations reported. The global trials are assessing the safety and efficacy of the vaccine in individuals aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.

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The Pharma Data

NOVEMBER 30, 2020

CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix?M. pivotal Phase 3 trial update. South Africa Phase 2b trial update. Mexico pivotal Phase 3 trial update. United Kingdom (U.K.)

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Delveinsight

DECEMBER 22, 2020

Vorasidenib is an investigational, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 in a Phase III trial in patients with IDH-mutant low-grade glioma, AG-270 is an investigational first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor while AG-636 is a novel inhibitor of dihydroorotate dehydrogenase.

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pharmaphorum

AUGUST 16, 2020

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

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Drug Discovery World

JULY 5, 2023

Decades of research on the cellular and molecular mechanisms of how the immune system detects and kills cancerous or pre-cancerous cells, known as immune surveillance, and the factors which modulate that response, have led to understanding how we can enable a patient’s own immune system to fight cancer more efficiently in different ways.

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The Pharma Data

NOVEMBER 9, 2020

Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant. Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. and globally.”. About NVX-CoV2373.

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pharmaphorum

OCTOBER 6, 2020

In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted. The vaccine is based on different technology from AZ’s rival: while AZ’s uses a weakened and genetically modified cold virus to prime the immune system, BNT162b2 is based on a string of RNA.

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XTalks

AUGUST 17, 2020

Cue Biopharma is a Cambridge, Massachusetts-based clinical-stage biotechnology company that is focused on developing injectable immune biologics using its proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform. Cell-Based Immunotherapy vs. Immune Biologics. protein-based biologics) and vaccine treatments.

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Drug Discovery World

JULY 25, 2023

Background Lymphocyte-activation gene 3, or LAG-3, is a gene that provides the genetic information to make a cell surface molecule with biologic effects on T-cell function. Two years after this discovery, his team was able to show that the LAG-3 protein was a ligand for MHC Class II molecules like CD4.

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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. and Leila Zegna, director of the Kabuki Syndrome Foundation.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Regeneron Pharmaceuticals, Inc.

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The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S. Regeneron Pharmaceuticals, Inc.

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pharmaphorum

SEPTEMBER 8, 2021

Kadmon claimed approval for Rezurock (belumosudil) in July as a treatment for chronic graft versus host disease (GVHD) – a common and often fatal complication that can follow a bone marrow transplant and which occurs when the donated cells mount an immune response against the transplant recipient’s tissues and organs.

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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. Thirteen patients are waiting for their vaccine to be made.

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Delveinsight

SEPTEMBER 23, 2021

Boehringer stated that the Abexxa’s generation aims at cancer-specific proteins situated throughout the mobile versus proteins at the mobile membrane broadening the selection of possible cancer antigen objectives. have helped prepare more than 20 drug candidates for clinical trials. Stafford and co.

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The Pharma Data

OCTOBER 27, 2020

Foghorn is anticipating filing an IND later this year for its lead candidate to begin a Phase I trial for the treatment of uveal melanoma, a cancer of the eye. . AavantiBio’s strategic partnership with University of Florida’s Powell Gene Therapy Center provide their foundational research in rare genetic disorders. Be Biopharma .

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Gene Gene Therapy Medicine Genetics 52

The Pharma Data

JULY 6, 2021

Hemophilia is a rare, genetic bleeding disorder in which a person’s blood does not clot properly. New research will also be presented on Eloctate ® Antihemophilic Factor (Recombinant), Fc Fusion Protein, Sanofi’s extended half-life factor VIII therapy for people with hemophilia A. ePoster Abstract # OC48.2

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Protein RNA Marketing Development 52

Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

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Pharmaceutical Technology

JANUARY 19, 2023

Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain. The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial.

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Delveinsight

DECEMBER 3, 2020

Roche has got an authorization from the FDA for a more accurate COVID-19 blood test capable of measuring the levels of specific antibodies, which target the cell-unlocking spike protein of coronavirus. A phase 3 trial of Ovid Therapeutics’ OV101 in Angelman syndrome has flunked its primary endpoint.

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The Pharma Data

DECEMBER 18, 2020

The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. Director of the FDA’s Center for Biologics Evaluation and Research.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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World of DTC Marketing

DECEMBER 29, 2020

These vaccines were developed using different “platform technologies” that involve slotting genetic material from the virus into a tried and tested delivery package. Another consideration is that while in traditional vaccine development, clinical trials are carried out in sequence. Then there are the finances.

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The Pharma Data

JUNE 25, 2021

Nasdaq: NVAX), today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. Novavax, Inc. Government.” Variant Virus Strains.

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