The Pharma Data

JANUARY 31, 2021

Clover’s S-Trimer antigen adjuvanted with CpG 1018 plus alum demonstrated low reactogenicity while providing high levels of neutralizing antibodies and a strong Th1-biased cell-mediated immune response. Food and Drug Administration (FDA).

Vaccine

The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

FDA

The Pharma Data

JANUARY 31, 2021

Gilead and Gritstone will develop an HIV-specific therapeutic vaccine using Gritstone’s proprietary prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead. This press release features multimedia. View the full release here: [link].

Vaccine

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S.

Hospitals

Drug Target Review

JULY 7, 2023

Antibodies protect us by attaching to molecules on those invaders (known as antigens) and triggering our body’s natural immune response to destroy them. This can create an abnormal immune response that attacks the cells of our bodies and contributes to the development of autoantibody diseases.

Disease

Drug Target Review

JANUARY 15, 2024

Each T cell expresses a TCR specific for an HLA‑presented peptide signal, and when that signal is detected a T cell expressing the relevant TCR can launch a complex array of immune effector responses that can suppress or destroy tumours or virus-infected cells. Many potential candidate antigens are under consideration.

Engineering

Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

Therapies

Alta Sciences

APRIL 11, 2025

Best Practices for Preclinical Dose Range Finding Studies pmjackson Fri, 04/11/2025 - 20:05 Dose range finding (DRF) studies are the foundation of preclinical drug development, providing crucial information on safety data to assist in the dose level selection before advancing into toxicology studies.

Immune Response

The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Yancopoulos, M.D.,

Therapies

DrugBank

FEBRUARY 26, 2025

This discovery represents a shift in how antibiotics are identified, showcasing the potential of AI to uncover entirely new drug classes. Developing Antimicrobial Peptides and Biomolecules In addition to traditional small-molecule antibiotics, researchers are exploring the potential of antimicrobial peptides (AMPs) and other biomolecules.

Therapies

The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Yancopoulos , M.D.,

FDA

The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., did not have antibodies at baseline: seronegative), as prior evidence suggested these patients were at greater risk. futility analysis). .

Hospitals

The Pharma Data

NOVEMBER 29, 2020

3 The majority of CMV infections are not serious, and the virus can lay dormant in the body for years. However, CMV infection poses a considerable risk to infants in utero, as well as immune-compromised individuals, such as solid organ transplant recipients. Human Cytomegalovirus Resistance to Antiviral Drugs.

Vaccine

The Pharma Data

JANUARY 11, 2021

Upon binding, the antibodies block the spike protein from interacting with ACE2 and thereby prevent virus-induced cell-killing, also known as cytopathic effect. Our antibody clones in their original IgG format have shown potent neutralization activity in in vitro assays and, in the case of our lead clone, in an in vivo animal model.

Licensing

Codon

SEPTEMBER 29, 2024

It wasn’t a silver bullet to the hard problem of drug development, but it wasn’t too far off either. Another camp believed nucleotides insufficient and that proteins were what mattered, pushing hundreds of millions of dollars into developing high-throughput proteomic sequencing platforms.

Engineering

NIH Director's Blog: Drug Development

JUNE 30, 2020

A major one is: just how well do those particular antibodies neutralize the virus to fight off the infection and help someone recover from COVID-19? Fortunately, most people get better—but should the typical antibody response take the credit? Not surprisingly, all volunteers had produced antibodies in response to the virus.

Immune Response

NIH Director's Blog: Drug Development

MAY 21, 2020

B38 blocks SARS-CoV-2 from binding to the ACE2 receptor (light pink) of a human cell, ACE2 is what the virus uses to infect cells. References : [1] Humoral immune response and prolonged PCR positivity in a cohort of 1343 SARS-CoV 2 patients in the New York City region. In the U.S. Preprint Posted May 5, 2020. [2]

Virus

The Pharma Data

OCTOBER 26, 2020

In addition, the observed median PFS shows that the regimen can induce a sustained and durable response, which is also shown consistently by the induction of a specific immune response. 27, 2020 06:30 UTC. Commenting on this novel immunotherapy regimen, Prof. Christophe Le Tourneau, M.D.,

Vaccine

NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

They are called immune modulators because they help to minimize the effects of an overactive immune response in some COVID-19 patients. This response, called a “cytokine storm,” can lead to acute respiratory distress syndrome, multiple organ failure, and other life-threatening complications.

Clinical Trials

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.

FDA

Vial

DECEMBER 11, 2023

Hepatitis C virus (HCV) infection is a global health problem with complications that place a significant economic burden on national health systems. Genetic variability The genetic diversity of HCV poses a significant challenge in vaccine development. On top of this, treated individuals are susceptible to reinfection.

Clinical Research

NIH Director's Blog: Drug Development

MARCH 18, 2021

Yet they are the source for many of the viruses that have spilled over into humans with devastating effect, including rabies, Ebola virus, Nipah and Hendra viruses, severe acute respiratory syndrome coronavirus (SARS-CoV), and, likely, SARS-CoV-2. Despite carrying all of these viruses, bats rarely show symptoms of being sick.

Virus

NIH Director's Blog: Drug Development

FEBRUARY 1, 2022

The ACE2 drug candidate, which is soluble and degrades in the body, also proved ineffective in neutralizing the virus. In the lab, it also appeared to neutralize the virus as well as monoclonal antibodies used to treat COVID-19. In fact, the decoy bound just as well, if not better, to new variants compared to the original virus.

Virus

The Pharma Data

SEPTEMBER 8, 2020

is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies.

Science

The Pharma Data

SEPTEMBER 8, 2020

Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies.

Science

SugarCone Biotech

MAY 28, 2019

In January 2020 four papers were published that described the correlation between the presence of tertiary lymphoid organs and B cells with successful immune checkpoint therapy in diverse cancer indications (see here ). Fc-hacking immune responses.

Immune Response