The Pharma Data

AUGUST 22, 2021

AZD7442 is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by convalescent patients after SARS-CoV-2 virus. Fc-mediated antibody effector functions during respiratory syncytial virus infection and disease. Approximately 43% of participants were 60 years and over.

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The Pharma Data

AUGUST 21, 2020

When COVID-19 began to emerge – first in Asia, then in Europe – she could see that its relative ease transmitting from person to person, along with the lack of tests and preventions or treatments for infection, made the virus a credible threat to humanity. These will be screened against SARS-CoV-2. Source link.

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The Pharma Data

NOVEMBER 5, 2020

5 of its ongoing Phase 2 extension study, Study 211, examining vebicorvir (VBR, or ABI-H0731) in patients with hepatitis B virus infection. We maintain this can best be accomplished through a combination of agents with different mechanisms of action that target distinct parts of the virus lifecycle. Assembly Biosciences, Inc.

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Drug Target Review

SEPTEMBER 25, 2024

A phase 1, first-in-human, open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of TT125-802 in patients with advanced solid tumors. Available from: [link] 8.Boni Boni V, Garralda E, Colombo I, Krisztian Homicsko, Brana I, Gruber D, et al. Journal of Clinical Oncology [Internet]. Available from: [link] 9.Mohanty

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The Pharma Data

JULY 23, 2021

Ronapreve is a combination of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19. As soon as the novel SARS-CoV-2 virus was sequenced in early 2020, we got to work.

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The Pharma Data

DECEMBER 14, 2020

The Phase I trial is a randomized, double-blind, placebo-controlled study that is meant to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending doses of ABBV-47D11. Under the collaboration agreement, researchers are looking into the elimination of the SARS-CoV-2 virus and virally infected cells by K-NK cells.

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The Pharma Data

APRIL 7, 2021

The EC’s approval of the SC route of administration for TYSABRI is based on data from the DELIVER and REFINE studies, which showed comparability to the Q4W IV administration of 300mg TYSABRI in efficacy, pharmacokinetic and pharmacodynamic profiles. Patients who have all three risk factors have the highest risk of developing PML.

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The Pharma Data

MARCH 9, 2021

They can prevent the HIV replication process by blocking key enzyme activity at this stage, which results in the formation of immature virus particles. The primary endpoint was the maximum change in plasma HIV-1 RNA during parts one and two while secondary endpoints measured safety, tolerability, and pharmacokinetic (PK) parameters.

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The Pharma Data

MARCH 26, 2021

New in vitro data from pseudotyped virus assays published online in bioRxiv in March 2021 support this hypothesis as they demonstrate that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants. About the Vir and GSK Collaboration.

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DrugBank

FEBRUARY 26, 2025

Our platform offers an extensive database of drug interactions, molecular targets, and pharmacokinetics, providing researchers with the tools to identify and optimize effective compounds. This discovery represents a shift in how antibiotics are identified, showcasing the potential of AI to uncover entirely new drug classes.

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The Pharma Data

APRIL 16, 2021

1.429 California strain that currently accounts for 50 percent of the virus in California and over 10 percent across a number of additional states. Due to the rapidly evolving and geographically diverse nature of the SARS-CoV-2 virus, continued scientific innovation remains critical to develop additional treatments. In the U.S.,

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The Pharma Data

APRIL 22, 2023

Results from a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of obeldesivir, previously known as GS-5245, a novel investigational oral compound being developed by Gilead for the treatment of SARS-CoV-2 infection, showed obeldesivir reaches expected therapeutic plasma concentrations for the treatment of COVID-19.

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PerkinElmer

JUNE 3, 2022

Writing in JACS , the researchers concluded: “Based on the broad-spectrum antiviral effect combined with promising selectivity and in vitro pharmacokinetic profile, the scaffold represented by [this compound] is one of the most promising for development of an antiviral drug targeting SARS-CoV-2.”

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The Pharma Data

SEPTEMBER 26, 2021

The positive CHMP opinion was supported data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA® (dimethyl fumarate) to determine bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied partially on the well-established long-term safety and efficacy profile of TECFIDERA.

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The Pharma Data

APRIL 14, 2021

It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function.

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The Pharma Data

MAY 7, 2021

The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, and less likely to mutate over time. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus.

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The Pharma Data

DECEMBER 23, 2020

The study’s primary endpoints include safety, tolerability and pharmacokinetics of anle138b in Parkinson’s patients in order to establish the optimal dosing scheme for future long-term efficacy trials. Anle138b is a disease-modifying treatment option for synucleinopathies, such as Multiple System Atrophy (MSA) and PD. Most Read Today.

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The Pharma Data

JANUARY 26, 2021

BLAZE-4 Additionally, initial results from the ongoing BLAZE-4 trial provide viral load and pharmacodynamic/pharmacokinetic data which demonstrated lower doses, including bamlanivimab 700 mg and etesevimab 1400 mg together, are similar to bamlanivimab 2800 mg and etesevimab 2800 mg together.

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The Pharma Data

DECEMBER 15, 2020

The Phase I/IIa clinical trial is a randomized, double-blind, placebo controlled, single and multiple dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NMD670 in 79 male and female healthy subjects and patients with myasthenia gravis. The secondary outcome involves pharmacokinetic endpoints.

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The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. Use in Specific Populations.

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The Pharma Data

JANUARY 3, 2021

The pharmacokinetics of nasally administered Foralumab will also be evaluated. . The primary endpoint of this study was safety of the treatment, and secondary endpoints were to evaluate the effect of treatment on disease severity symptoms, nasal tolerance, sense of smell, and biomarkers for disease progression.

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The Pharma Data

NOVEMBER 22, 2020

Molecular Partners two antiviral DARPin® candidates, MP0420 and MP0423, are designed to target multiple different sites on the SARS-CoV-2 virus simultaneously for enhanced antiviral effects and potential use as both prophylactics and treatments. About Molecular Partners’ anti-COVID-19 program.

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Agency IQ

DECEMBER 1, 2023

The guidance also provided insight on new issues that had arisen since the first version of the guidance was published ; for example, the potential for drug resistance and the impact of virus shedding and immune response. These topics were covered in the body of the guidance and were addressed in two new appendices.

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Codon

APRIL 2, 2023

Therapeutic neutralizing monoclonal antibody administration protects against lethal yellow fever virus infection. Read A really simple way to isolate AAVs, which are a type of virus often used to deliver gene therapies into cells. Only about 15% of antibodies actually neutralize the new variants. Ricciardi M.J. Gene Therapy.

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The Pharma Data

MAY 4, 2021

It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function.

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The Pharma Data

MARCH 5, 2021

It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function.

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The Pharma Data

MARCH 11, 2021

It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function.

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The Pharma Data

SEPTEMBER 15, 2020

Of note, The Phase 1b study is a double-blind, placebo-controlled clinical trial evaluating the safety, tolerability and pharmacokinetics of PF-07304814, a phosphate prodrug that when administered intravenously is metabolized to the active compound PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.

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The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

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Agency IQ

AUGUST 16, 2024

Pharmacokinetic (PK) sample and analysis planning: Generally, the recommendations in the final guidance are nearly identical to those contained in the draft, with a few exceptions. Likewise, it still omits radiopharmaceuticals, cancer vaccines, cell and gene therapy products, and microbiota-related products from its scope.

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The Pharma Data

SEPTEMBER 1, 2020

Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod. Presentation Topic: Reproductive Aspects and Pregnancy. Studies Evaluating Zeposia Benefit to Risk Profile. Author: Zhang. Presentation Number: P0343.

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Codon

FEBRUARY 23, 2025

Experimenting with a retrovirus called murine leukemia virus , he found that zidovudine did, in fact, obstruct retrovirus replication by inhibiting reverse transcriptase. Healthcare workers who became exposed to the virus while treating patients in the 1980s took zidovudine as a prophylactic. Subscribe to Asimov Press! Always free.

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