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. Curing HIV remains the ultimate aspiration for Gilead’s HIV research and development efforts.

Vaccine

The Pharma Data

NOVEMBER 16, 2020

and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S.

Vaccine

BioPharma Drive: Drug Pricing

JULY 23, 2025

According to Dispatch, its therapies use an engineered virus — a common gene therapy delivery tool — to seek out cancerous cells and tag them with what it refers to as a “flare.” The engineered virus also delivers inflammatory cytokines and chemokines to help take down a tumor’s surrounding environmental defenses.

Therapies

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.

Engineering

The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

Drug Development

The Pharma Data

NOVEMBER 29, 2020

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. 21 participants were vaccinated with HB-101 and 12 received placebo. NEW YORK and VIENNA, Austria, Nov.

Vaccine

The Pharma Data

NOVEMBER 30, 2020

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

Vaccine

PerkinElmer

APRIL 21, 2020

Although the novel coronavirus is the subject of nearly every media story right now, several years ago it was the Zika virus (ZIKV) gathering a great deal of attention. There are currently no targeted therapeutics for its treatment, nor is there an existing vaccine.

Virus

The Pharma Data

JANUARY 12, 2021

“Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. “Additionally, as expected, the virus continues to mutate, with the possibility of developing resistance to any one antibody. . Schleifer , M.D., President and Chief Executive Officer of Regeneron.

Government

EG Life Sciences

FEBRUARY 15, 2023

The year 2022 reflected a transformative path for the drug development industry. Every year, the FDA’s Center for Drug Evaluation and Research (CDER) clarifies to drug developers required study design elements, as well as other data needed on the drug application to support a full and comprehensive assessment.

Drug Development

The Pharma Data

FEBRUARY 25, 2022

Specifically, the team found that these drugs inhibit certain viral enzymes, called proteases, that are essential for SARS-CoV-2 replication in infected human cells. “There remains an urgent need for SARS-CoV-2 therapeutic agents that target parts of the virus other than the spike protein that are not as likely to evolve.”

FDA Approval

The Pharma Data

APRIL 25, 2021

Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. Respiratory Syncytial Virus (RSV) is the leading cause of hospitalization in all infants. 1 – 5. RSV is the most common cause of LRTI and the leading cause of hospitalizations in all infants.

Virus

NIH Director's Blog: Drug Discovery

MAY 26, 2016

He joined the Scripps lab to become a structural biologist and a few years later used single-particle cryo-EM to help determine the atomic structure of a key protein on the surface of the human immunodeficiency virus (HIV), the cause of AIDS. Now, Lyumkis has plans to take single-particle cryo-EM to a whole new level—literally.

Virus

The Pharma Data

NOVEMBER 20, 2020

“The casirivimab and imdevimab antibody cocktail is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D. Yancopoulos, M.D., President and Chief Scientific Officer of Regeneron.

Therapies

The Pharma Data

JANUARY 13, 2021

We are pleased vaccines are now approved for the prevention of COVID-19; however, a significant unmet need remains for effective treatments for symptomatic patients. We believe ensifentrine, with its novel mechanism of action, could help to improve COVID-19 patient outcomes.”.

Hospitals

The Pharma Data

OCTOBER 27, 2020

The collaboration aims to leverage Molecular Partners’ proprietary DARPin® technologies and Novartis’ broad expertise in global drug development, regulatory affairs, manufacturing and commercialization to rapidly advance the program in keeping with the unprecedented global urgency created by the pandemic.

Therapies

The Pharma Data

OCTOBER 27, 2020

28, 2020 /PRNewswire/ — Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, today announces the formation of a new Scientific Advisory Board (SAB). OSLO, Norway , Oct. Fennel cover the key scientific focus areas of Targovax. Dean A.

Virus

The Pharma Data

NOVEMBER 21, 2020

.” “REGEN-COV2 is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D. REGEN-COV2’s development and manufacturing has been funded in part with federal funds from BARDA under OT number: HHSO100201700020C. Yancopoulos , M.D.,

FDA

The Pharma Data

JUNE 2, 2022

Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development hosted by A*STAR, then optimized the antibodies and confirmed their applicability to a range of other solid cancers.

Licensing

PerkinElmer

JANUARY 21, 2021

Using drugs that are already on the market was the quickest path forward to evaluate these compounds and possibly help patients now because novel drug development typically takes years. Scientists needed to evaluate the field of potential drugs-and fast. It is, therefore, a tricky target for drugs.

Treatment

The Pharma Data

OCTOBER 28, 2020

It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. patients who recovered from COVID-19. .

Government

The Pharma Data

OCTOBER 15, 2020

The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. The committee is tasked with supporting BeyondSpring’s business development activities related to its lead asset, Plinabulin, and other pipeline assets. BeyondSpring – BeyondSpring Inc. Source link.

Pharmaceuticals

BMG Labtech

MARCH 11, 2024

biomarker discovery), blood typing, autoimmune diseases, food science (including allergy testing), infectious disease surveillance, drug discovery and development as well as vaccine development. This type of application helps guide the development and optimization of therapeutics.

Vaccine

Advarra

JUNE 27, 2023

The Importance of Clinical Research in Medical Advancements Researchers use clinical trials to test a drug’s or other medical treatment’s safety and efficacy. Most modern medicines were developed from clinical trials , and clinical trials remain essential for drug development.

Clinical Research

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

PerkinElmer

AUGUST 18, 2020

This is especially applicable to labs involved in the development of highly sought-after viral therapeutics and vaccines. The time sensitivity of virus research, combined with an increasing complexity of bench tasks, can make it helpful for labs to increase automaticity of experiments.

Virus

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. Structural illustration of B38 antibody (cyan, green) attached to receptor-binding domain of the coronavirus SARS-CoV-2 (magenta). In the U.S.

Virus

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

The Pharma Data

OCTOBER 26, 2020

Christophe Le Tourneau, MD, Head of the Department of Drug Development and Innovation (D3i) at the Curie Institute, and Principal Investigator of the trial , added: “We have seen very encouraging efficacy results in this hard-to-treat patient population, as well as a satisfying safety profile. Methods.

Vaccine

Agency IQ

JULY 8, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. The information below includes the event type and whether the meeting can be attended by the public (Open) or not (Closed).

Regulations

The Pharma Data

OCTOBER 18, 2020

PhD, Head of the Department of Drug Development and Innovation (D3i) at the Curie Institute, and a world expert in drug development and head and neck cancers, is the Principal Investigator of the study. Vaccines for established cancer: overcoming the challenges posed by immune evasion Nat Rev Cancer. References. [1]

Vaccine

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? In the Nussenzweig lab, the team has spent years searching for broadly neutralizing antibodies against the human immunodeficiency virus (HIV ). Yet many critical questions remain.

Immune Response

Agency IQ

DECEMBER 1, 2023

For example, reflecting the development of a new standard of care for Covid-19, the guidance stated that “in some situations, use of an active control with a superiority or non-inferiority design may be appropriate.” These topics were covered in the body of the guidance and were addressed in two new appendices.

FDA

NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

Yet the quest to save more lives from COVID-19 isn’t even close to being finished, and researchers continue to work intensively to develop new and better treatments. ACTIV was founded last April to accelerate drug research that typically requires more than a decade of clinical ups and downs to develop a safe, effective therapy.

Clinical Trials

The Pharma Data

OCTOBER 26, 2020

Demand for our products remains robust, and production, supply and distribution of our medicines, vaccines and animal health products are moving forward with minimal disruption,” said Kenneth C. The FDA has granted V181, the company’s investigational dengue vaccine in Phase 1 development, Fast Track designation.

Vaccine

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Published June 23, 2025 Delilah Alvarado Staff Reporter post share post print email license A micrograph image of influenza A virus. Influenza A virus" [Micrograph]. Study success could open the door to an alternative to seasonal influenza vaccines, which some Wall Street analysts view as a multibillion-dollar sales opportunity.

Drugs

BioPharma Drive: Drug Pricing

JULY 21, 2025

Elevidys, and Sarepta’s experimental limb-girdle treatment, use a type of engineered virus — called AAV for short — that’s become a go-to method for delivering functional genes to target cells. Researchers have warned, though, that high doses of these therapies present notable risks, which now appear back in the spotlight.

Therapies