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.

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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.

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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. 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.

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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.

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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.

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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.

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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.

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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.

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Vaccine Vaccination RNA Clinical Trials 88

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.

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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.

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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.

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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.

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Trials Drug Delivery Drugs Gene 83

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.

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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.

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Protein Pharma Companies RNA Drugs 121

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.

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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.

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Clinical Trials Clinical Trials Vaccine Vaccination 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.

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Vaccine Vaccination Trials Immune Response 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. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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Clinical Trials Clinical Trials Vaccine Vaccination 52

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.

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

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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.

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Clinical Trials Clinical Trials Vaccine Vaccination 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.

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Clinical Trials Clinical Trials Vaccine Vaccination 52

pharmaphorum

MARCH 9, 2022

Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new long-acting drug candidate can revitalise the franchise.

Protein 98

Protein Gene Therapy Sales Regulation 98

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.

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Vaccine Vaccination Trials Protein 52

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.

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Vaccine Vaccination Trials Immune Response 52

pharmaphorum

OCTOBER 22, 2020

AT-527 works by blocking the viral RNA polymerase enzyme needed for viral replication. It is currently being studied in a phase 2 clinical trial for hospitalised patients with moderate COVID-19. Phase 3 trials are expected to start in Q1 2021, and will test the drug outside of the hospital setting. .”

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Development Branding RNA Manufacturing 66

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.

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Vaccine Vaccination Trials Immune Response 40

The Pharma Data

AUGUST 16, 2021

Better activation of innate and adaptive immune responses was achieved with CV2CoV, resulting in faster response onset, higher titers of antibodies, and stronger memory B and T cell activation as compared to the first-generation candidate, CVnCoV. The first clinical trial of CV2CoV is expected to start in Q4 2021.

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Immune Response Vaccine Vaccination Antibody 52

pharmaphorum

APRIL 5, 2022

AstraZeneca’s take on the PCSK9 inhibitor – an antisense drug licensed from Ionis six years ago – has cleared a proof-of-concept trial in high-risk patients with high blood cholesterol, but it remains to be seen where it will fit into the increasingly busy category.

Drugs 52

Drugs Antibody Sales FDA Approval 52

The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. Silverback’s lead candidate is currently in a Phase I trial in adults with HER2-expressing solid tumors. Reduce cost. Nuance Pharma .

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RNA Antibody Life Science Protein 52

Delveinsight

JULY 29, 2021

billion in biobucks on the table to buy Teneobio and its suite of bispecific and multispecific antibody technologies focused on cancer and other disease targets. Biogen-Ionis’ experimental drug meets primary goal in Alzheimer’s trial. Amgen has penned a major new buyout deal to boost its oncology pipeline further.

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The Pharma Data

SEPTEMBER 9, 2020

Immunization of non-human primates (rhesus macaques) with BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate that expresses the SARS-CoV-2 spike glycoprotein, resulted in strong anti-viral effects against an infectious SARS-CoV-2 challenge. BNT162b2 vaccination elicited a high frequency of CD4+ T cells that produced IFN-?

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Vaccine Vaccination RNA Clinical Trials 52

XTalks

JANUARY 25, 2021

Although TaiMed Biologics’ antibody drug Trogarzo is an intravenous formulation that is administered once every 14 days, it must be used in conjunction with other antiretroviral drugs. ATLAS and FLAIR Phase III Trials. In the FLAIR trial , a 48-week Cabenuva regimen led to virologic suppression in 93.6 Opening up Options.

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 52

The Pharma Data

MAY 3, 2021

Pfizer reported that it submitted its application for extension of authorization last week, and EMA announced today that it has undertaken the evaluation of the messenger RNA (mRNA) vaccine. No cases of COVID-19 were seen in the vaccinated trial arm, while 18 cases were reported among placebo recipients. .

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Vaccine Vaccination Antibody RNA 52

The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

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The Pharma Data

JANUARY 12, 2021

About JTX-8064 JTX-8064 is a humanized IgG4 monoclonal antibody designed to specifically bind to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4) and block interactions with its ligands. About JTX-4014 JTX-4014 is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2.

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Clinical Trials Clinical Trials Antibody Trials 52

BioSpace

NOVEMBER 20, 2022

Former Theranos CEO Elizabeth Holmes will serve 11 years in prison on four counts of fraud, according to her sentencing by a federal judge in a California courtroom on Friday afternoon.

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