XTalks

FEBRUARY 12, 2025

Current PCSK9 inhibitors on the market include Regenerons monoclonal antibody Praluent (alirocumab), Amgens Repatha (evolocumab) and Novartiss Leqvio (inclisiran), which is a small RNA interference (siRNA) therapy designed to lower LDL-C. Over 2,400 patients have continued in the 72-week open-label extension trial.

Cardiology 59

Cardiology Trials Clinical Trials Clinical Trials 59

XTalks

JANUARY 21, 2025

The liquid portion of the blood (serum or plasma) containing antibodies is separated and tested using the Liason Biotrin parvovirus B19 IgG plus test on a Liason XL analyzer. If parvovirus B19 antibodies are present, they bind to the chemicals and particular particles in the test, producing a light signal.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

Pharmaceutical Technology

AUGUST 24, 2022

Mode rna has submitted an application to the US Food and Drug Administration (FDA) to obtain emergency use authorization (EUA) for mRNA-1273.222, its BA.4/BA.5 According to the findings, the trial of mRNA-1273.214 met all primary endpoints. At present, a Phase II/III trial of mRNA-1273.222 is progressing. 1 subvariant.

Vaccination 130

Vaccination Vaccine Gene Therapy Antibody 130

XTalks

APRIL 22, 2022

Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. In a recent webinar, Dr. Olsson described the benefits of flow cytometric receptor occupancy assays in clinical trials. What is Flow Cytometry?

Clinical Trials 98

Clinical Trials Clinical Trials Trials Antibody 98

Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 1 clinical trial, which is ongoing. The therapeutic candidate consists of messenger RNA (mRNA) encoding for relaxin. It is developed based on messenger RNA expression and N2GL formulation platform. Buy the model here. The drug candidate is administered by intravenous route.

RNA 100

RNA Protein Antibody Vaccine 100

Pharmaceutical Technology

FEBRUARY 1, 2023

Since the FDA approved AstraZeneca’s monoclonal antibody therapy Synagis (palivizumab) 25 years ago, drug development successes for RSV have been few and far between. However, subsequent RSV drugs, like Medimmune’s motavizumab, failed in clinical trials.

Vaccination 162

Vaccination Vaccine Antibody Development 162

pharmaphorum

JULY 13, 2022

Verve Therapeutics has started dosing patients in a phase 1b trial of its in vivo gene-editing drug for high cholesterol, designed to permanently switch off the PCSK9 gene with a one-shot treatment. Early trials suggest it as efficacy that matches the injectables, but the winner in the PCSK9 category remains hard to pick.

Gene Editing 98

Gene Editing Trials Drugs In-Vivo 98

World of DTC Marketing

MARCH 16, 2021

Do I have a responsibility to share — on every occasion, random and formal, to family, friends, and strangers alike — my knowledge on the vaccines, monoclonal antibodies, the latest news from the Lancet or JAMA, why RNA is not voodoo, how Phase 4 safety trials are happening as I write…The answer is simple: yes.

Marketing 180

Marketing Vaccine Vaccination RNA 180

pharmaphorum

DECEMBER 13, 2021

In June, BioNTech started the first phase II trial of BNT111, an mRNA vaccine candidate for skin cancer and later announced plans to move mRNA therapeutics against malaria and tuberculosis into the clinic in 2022 as well as plans to set up a sustainable vaccine production and supply network in Africa. mRNA-based vaccine trial development.

RNA 105

RNA Vaccine Vaccination Development 105

Pharmaceutical Technology

JUNE 8, 2023

The company’s samRNA vector is based on a synthetic RNA molecule derived from a wild-type Venezuelan Equine Encephalitis Virus (VEEV) replicon with the goal of extending the duration and magnitude of immunogen expression to drive potent and durable immune responses. GlobalData is the parent company of Clinical Trials Arena.

Vaccination 130

Vaccination Vaccine Immune Response Allergies 130

Delveinsight

AUGUST 26, 2021

Shape’s RNA editing technologies can modify the RNA sequence, which makes the body’s protein building blocks. This system is designed to deliver RNA editing technology or other payloads directly to particular body areas, such as the nervous system or muscle. and Leila Zegna, director of the Kabuki Syndrome Foundation.

Vaccine 98

Vaccine Vaccination Gene Therapy RNA 98

pharmaphorum

JANUARY 7, 2022

NI006 is an antibody that binds to the misfolded forms of the transthyretin protein that form the fibrils, and cause them to be cleared away by immune cells like macrophages. billion on the first nine months of 2021, well ahead of Pfizer’s own forecasts. Tafamidis is thought to work by stabilising the misfolded proteins.

Antibody 116

Antibody Licensing Licensing Protein 116

The Pharma Data

OCTOBER 30, 2020

Neutralizing Antibody Shows Potential for Mild-to-Moderate COVID-19. 30, 2020 — Viral load was decreased at day 11 for patients with mild or moderate COVID-19 who received a single intravenous infusion of virus-neutralizing monoclonal antibody versus placebo, according to a study published online Oct. Professional. FRIDAY, Oct.

Antibody 52

Antibody RNA Medicine Trials 52

Pharmaceutical Technology

JULY 5, 2022

On leaving the liver cells, the virus hijacks bits of cell membrane and conceals itself from antibodies that would have isolated the virus before it travelled far through the bloodstream. In addition, the scientists later found that the HAV needs TENT4A/B for its replication.

Protein 130

Protein RNA Genome Genomics 130

pharmaphorum

FEBRUARY 9, 2021

million ($22 million) in second-round financing as it prepares to start clinical trials of its lead drug candidate INT-1B3 for solid tumours. The start of dosing in the phase 1/1b trial of the drug has been delayed by the COVID-19 pandemic, but recruitment of the target 80 participants with advanced solid tumours is reported to be ongoing.

Trials 59

Trials Gene Silencing RNA Gene Expression 59

pharmaphorum

SEPTEMBER 16, 2020

Both of these vaccines are based on RNA and in phase 3 and phase 1 testing, respectively. Earlier clinical data has shown that the vaccine can stimulate neutralising antibodies against SARS-CoV-2 and was well-tolerated with a transient mild to moderate fever being the main side effect seen in less than 20% of recipients.

Vaccination 85

Vaccination Vaccine RNA Trials 85

Delveinsight

SEPTEMBER 23, 2021

The biotech has evolved a T-cell receptor-like antibody to damage a selected immune checkpoint in oncology. 858 Therapeutics closes USD 60 Million series A round to drug RNA modulation. Now, they are ready for their next venture, which is launching RNA biotech 858 Therapeutics with a USD 60 million Series A fundraising.

RNA 61

RNA Gene Therapy Gene Protein 61

pharmaphorum

NOVEMBER 23, 2020

AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. Results from trials conducted in the UK and Brazil showed an efficacy of 90% in 2,741 patients receiving the vaccine as a half dose, followed by a full dose at least one month apart.

Vaccine 105

Vaccine Vaccination Regulation Protein 105

pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial.

Protein 126

Protein Vaccine Vaccination Immune Response 126

XTalks

JULY 14, 2022

Krystexxa’s expanded approval was based on data from the randomized, controlled MIRROR trial involving adults with uncontrolled gout. Results from the trial showed “significant improvement and sustained response” to Krystexxa with methotrexate (a chemotherapy drug and immune suppressant) compared to Krystexxa alone.

FDA Approval 105

FDA Approval Antibody Trials Drugs 105

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. Cohen speaks about the significant increase in complexity in the early clinical space, discussing factors including increasing development costs and increasing complexity of molecules and resulting trial designs.

Clinical Development 110

Clinical Development Development Clinical Trials Clinical Trials 110

pharmaphorum

DECEMBER 23, 2021

The first-in-class, small interfering RNA (siRNA) therapy for cholesterol lowering inhibiting PCSSK9 – the same target as Amgen’s Repatha (evolocumab) and Sanofi/Regeneron’s Praluent (alirocumab) – but after a lead-in period is dosed only twice a year rather than every month.

Drugs 105

Drugs Sales Antibody FDA Approval 105

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies.

Trials 83

Trials Drug Delivery Drugs Gene 83

XTalks

NOVEMBER 30, 2023

Over 26 weeks of Sunlenca combined with other antiretroviral drugs, 81 percent of participants achieved HIV RNA suppression, reaching levels low enough to be considered undetectable. Both trials concluded with maintained virologic suppression, and no clinically significant change from baseline in CD4+ cell counts was observed.

FDA Approval 111

FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

The Pharma Data

OCTOBER 25, 2020

The messenger RNA-based vaccine, which is designed to block replication of the coronavirus, was shown to induce neutralizing antibodies and activate T-cells in hamsters and mice. The vaccine is currently being evaluated in phase 1 and 2 human clinical trials. Source link.

Vaccination 52

Vaccination Vaccine Immune Response RNA 52

pharmaphorum

SEPTEMBER 22, 2022

Le Vert says Osivax’s technology differs, however, as it attacks the virus’ T-cells, making the vaccine more effective in the long term, and that clinical trials have shown promise. When exposed to a virus, one’s immune system develops antibodies in response to foreign antigens, with or without a vaccine.

Vaccination 97

Vaccination Vaccine Antibody Clinical Trials 97

pharmaphorum

NOVEMBER 9, 2020

Top-line results come from a phase 3 trial of the candidate known as BNT162b2 and an evaluation of 94 cases from the trial of 43,538 patients. Results will be discussed with regulators worldwide and the European Medicines Agency has already begun its rolling review of data to hasten a decision on the clinical trial dossier.

Vaccination 98

Vaccination Vaccine Clinical Trials Clinical Trials 98

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. About previously-published preclinical results.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

DECEMBER 8, 2020

8, 2020 — AstraZeneca’s COVID-19 vaccine is safe and effective, new data from late-stage trials shows. The interim findings are from phase 3 trials in the United Kingdom and Brazil that included more than 11,600 participants. TUESDAY, Dec. 8 in The Lancet. New data posted Tuesday on the U.S. © 2020 HealthDay.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

pharmaphorum

NOVEMBER 17, 2020

The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials. The company has picked four US states – Rhode Island, Texas, New Mexico and Tennessee, to trial a delivery programme that aims to overcome this challenge.

Vaccination 74

Vaccination Vaccine RNA Clinical Trials 74

The Pharma Data

JANUARY 20, 2021

-based Gritstone Oncology is developing a novel COVID-19 vaccine based on adenovirus and messenger-RNA technology designed to combat future variants of the coronavirus. Louis University. . Source link.

Vaccination 52

Vaccination Vaccine RNA Protein 52

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. These studies suggest BNT162b2 triggers the production of neutralising antibodies and T-cells that target SARS-CoV-2, the coronavirus that causes COVID-19.

Vaccination 59

Vaccination Vaccine RNA Immune Response 59

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

OCTOBER 26, 2023

The Flu versus COVID-19: Virology and Vaccines SARS-CoV-2 versus Influenza Virology Viruses contain genetic material that can either be RNA or DNA. Both influenza and SARS-CoV-2 have RNA as their genetic material. An RNA genome enables the genetic material to mutate more rapidly. For COVID, it is much the same case.

Vaccination 105

Vaccination Vaccine RNA Manufacturing 105

The Pharma Data

JUNE 25, 2021

To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 474 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis. Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

The Pharma Data

JANUARY 13, 2021

13, 2021 — A single-shot COVID-19 vaccine from Johnson & Johnson has shown very strong results in early clinical trials, potentially providing a significant boost to U.S. The vaccine produced an immune response of all 805 clinical trial participants within two months of inoculation, according to results published Jan.

Vaccination 40

Vaccination Vaccine Trials Immune Response 40