XTalks

APRIL 1, 2025

In hemophilia patients, inhibitors are antibodies that interfere with the effectiveness of clotting factor replacement therapies. Through RNA silencing, it targets the expression of antithrombin, a protein that inhibits blood clotting. The ATLAS-INH trial enrolled 77 patients with inhibitory antibodies to FVIII or FIX.

FDA Approval 52

FDA Approval RNA Clinical Trials Clinical Trials 52

pharmaphorum

OCTOBER 16, 2020

Sanofi will shortly start human trials of a second coronavirus vaccine, developed with US biotech Translate Bio, after reporting that it stimulated antibodies against SARS-CoV-2 in preclinical testing. It started human testing of a protein subunit vaccine with partner GlaxoSmithKline last month. Chinese inactivated vaccine safe.

Trials 98

Trials Vaccine Vaccination Antibody 98

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

Worldwide Clinical Trials

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Director, Therapeutic Area Medical Lead.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

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 Vaccination 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

Pharmaceutical Technology

FEBRUARY 1, 2023

AstraZeneca’s Synagis (palivizumab), which was approved in 1998, was the only monoclonal antibody (mAb) available for use to prevent RSV in high-risk infants for the past two decades. As an RNA virus, like SARS-CoV-2, RSV is highly prone to mutations.

Vaccination 162

Vaccination Vaccine Antibody Protein 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 Vaccination Vaccine 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 Vaccination Vaccine 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.

Vaccination 98

Vaccination Vaccine 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

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Another method to isolate CTCs is by antibody targeting of white blood cells for removal, followed by collection of untagged CTCs.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

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

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.

Vaccine 86

Vaccine Vaccination RNA Trials 86

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 Genomics Genome 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

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.

Vaccination 105

Vaccination Vaccine Regulation Protein 105

pharmaphorum

DECEMBER 1, 2020

The companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results. In the trial, BNT162b2 also showed an overall favourable tolerability with no safety concerns reported to date. The first primary objective analysis was based on 170 confirmed cases of COVID-19.

Vaccine 88

Vaccine Vaccination RNA Clinical Trials 88

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 Vaccination Vaccine 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 Gene 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.

Vaccine 52

Vaccine Vaccination Immune Response RNA 52

pharmaphorum

AUGUST 18, 2020

The consortium aims to rapidly develop drugs to fight SARS-CoV-2 and find virus neutralising antibodies. Hallett said that the targets being explored are the proteins involved in viral replication – the protease, the RNA polymerase, the papain-lie protease and elements of the “Spike” protein that allows the virus to infect cells.

Protein 121

Protein Pharma Companies RNA Drugs 121

The Pharma Data

JUNE 26, 2021

BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). The trial is enrolling a total of 120 patients and will evaluate the effects of the combination as well as single agents alone.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Immune Response 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.

Vaccine 97

Vaccine Vaccination 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.

Vaccine 98

Vaccine Vaccination Clinical Trials Clinical Trials 98

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.

Vaccine 77

Vaccine Vaccination RNA Clinical Trials 77

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