New Drug Approvals

DECEMBER 26, 2022

1 heavy chain (1-456) (human vh (homo sapiens ighv1-69*01(ighd)-ighj4*01 (90.1%)) (8.8.19) (1-126) -homo sapiens ighg1*03 Immunoglobulin g1, anti-(human respiratory syncytial virus fusion protein)(human monoclonal med18897.gamma.1-chain), 2] [3] Nirsevimab is designed to bind to the fusion protein on the surface of the RSV virus. [4]

Virus 52

Virus Clinical Trials Trials Disease 52

PerkinElmer

AUGUST 13, 2020

The virus, which can cause a severe form of pneumonia and lead to acute respiratory distress, currently has no FDA-approved targeted therapeutic or vaccine. For this reason, researchers around the globe are scrambling to understand this novel virus and figure out its potentially targetable vulnerabilities.

Virus 52

Virus Cell Based Assays FDA Approval Clinical Trials 52

PerkinElmer

JULY 13, 2020

From this data, scientists have begun to try to classify different subtypes and create phylogenetic trees of the virus to understand how the viral genome is evolving as it spreads across the globe. The question as to whether these genome variations lead to different strains of the novel virus (i.e. Why and how do viruses evolve?

Treatment 52

Treatment Virus DNA RNA 52

Advarra

JUNE 13, 2024

This blog describes why hazard communications are necessary and what an effective SOP should include. Depending on the genetic modifications of the oncolytic virus, exposure may result in an infection or disease with symptoms mimicking those from an infection by the native parent virus. Why Do You Need an SOP About IP Hazards?

Clinical Trials 52

Clinical Trials Engineering Trials Virus 52

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 52

Virus Drug Development Drugs Science 52

EG Life Sciences

FEBRUARY 15, 2023

Going into the third year of the pandemic, we know that the virus still impacts industry operations. Together, top vaccine development companies can join efforts, being transparent with one another to finally stop the spread of the virus around the world.

Drug Development 52

Drug Development FDA Approval Drugs Virus 52

PerkinElmer

JUNE 23, 2020

The pharmaceutical industry is no exception with clinical trials are underway to develop a vaccine and identify potential therapeutics. However, management of the virus continues to bewilder the world’s finest researchers and clinicians… and our traditional standards of pharmaceutical regulation have necessitated adaptation.

Clinical Trials 52

Clinical Trials Pharmaceuticals Trials Virus 52

PerkinElmer

JANUARY 21, 2021

It is particularly prevalent on cells that line the air sacs in lungs, hence the rampaging respiratory effects we’ve come to associate with the virus. AlphaLISA assay technology can be used in small molecule discovery but can also be applied to large molecule discovery, including biologics, vaccines and cell-based therapies.

Treatment 52

Treatment Small Molecule Drugs Virus 52

FDA Law Blog: Biosimilars

APRIL 7, 2025

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Zenrelia promotional materials also included claims about clinical data that the Agency found actionable.

Vaccine 64

Vaccine FDA Production Drugs 64

The Premier Consulting Blog

JUNE 18, 2023

The information gleaned from these in silico models was used to design and test medicines against the virus, speed-up the vaccine discovery pipeline, predict any therapeutic failures, and minimize undesired effects.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

PerkinElmer

JANUARY 25, 2023

Confronting and containing the spread of other infectious diseases like tuberculosis, influenza A and B as well as respiratory syncytial virus (RSV) also remained top global health priorities, as was testing to prevent the transmission of sexually transmitted infections, tickborne diseases and more. With the expanding territory of I.

Science 52

Science Laboratories Immune Response Disease 52

Codon

APRIL 2, 2023

mRNA vaccines and hybrid immunity use different B cell germlines against Omicron BA.4 Read How well do different antibodies, created by people who got two or three doses of the COVID-19 mRNA vaccine, fight off new viral variants, such as BA.4 Andreano E. Nature Communications. Ricciardi M.J. Science Translational Medicine.

DNA 52

DNA RNA Engineering Licensing 52

PerkinElmer

JUNE 14, 2021

The speed at which researchers developed effective vaccines to prevent the spread of COVID-19 required unprecedented international cooperation on a scale never seen before. Rollout of approved vaccines is underway in many countries across the globe, giving people hope that the end to the pandemic is finally in sight.

Virus 52

Virus Vaccine RNA Treatment 52

BMG Labtech

MARCH 11, 2024

In this blog, we look at immunoassays over the years, provide some examples of current and emerging applications, discuss some tips for optimization, and look at some of the benefits of the different ELISA options available to researchers. ELISAs can also be used to measure the antibody responses elicited by vaccines.

Vaccine 98

Vaccine Molecular Biology Laboratories Virus 98

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. Sources Zhang et al. – [link] Wen et al.

Virus 52

Virus Vaccine RNA DNA 52

Codon

APRIL 9, 2023

Read Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults. Read Rational design of a highly immunogenic prefusion-stabilized F glycoprotein antigen for a respiratory syncytial virus vaccine. npj Vaccines. Video explaining mRNA vaccines (h/t Morgan Cheatham ). Jerez-Longres C. Gene Therapy.

Therapies 52

Therapies RNA Engineering Vaccine 52

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 52

Virus Vaccine Laboratories Small Molecule 52

Codon

SEPTEMBER 29, 2024

On the surface, they hadn't deviated much from the early 2020s: a virus infected a cell and released the genetic therapy hidden within. Dozens of diverse chemical markers and de novo , evolutionary distinct proteins littered the virus' surface, indicating a previously unseen biological logic.

Engineering 144

Engineering Virus DNA Therapies 144

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 52

Immune Response Virus Vaccine Research 52

PerkinElmer

MAY 7, 2021

There’s a constant hunt for new, effective vaccines that could replace current, commonly used ones that viruses have developed a resistance to-and plate readers are commonly used to study viral mutations in vaccine research. The post Hey…Walkaway on the Automated Side first appeared on PerkinElmer Blog.

Vaccine 52

Vaccine DNA Compliance Virus 52

NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

A leader in this critical effort is NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV ) initiative, a public-private partnership involving 20 biopharmaceutical companies, academic experts, and multiple federal agencies. Vaccines Working Group : Accelerates the evaluation of vaccine candidates.

Clinical Trials 52

Clinical Trials Trials Hospitals Vaccine 52

Codon

MAY 15, 2023

link ) A phase I trial of a personalized neoantigen vaccine showed that they could boost T-cells and help fight off pancreatic tumors. — Niko McCarty Disclosure: The views expressed in this blog are entirely my own and do not represent the views of any company or university with which I am affiliated. Nature Communications.

DNA 52

DNA Bioinformatics Engineering Virus 52

Codon

MAY 15, 2023

link ) A phase I trial of a personalized neoantigen vaccine showed that they could boost T-cells and help fight off pancreatic tumors. — Niko McCarty Disclosure: The views expressed in this blog are entirely my own and do not represent the views of any company or university with which I am affiliated. Nature Communications.

DNA 52

DNA Bioinformatics Engineering Virus 52

PLOS: DNA Science

SEPTEMBER 7, 2023

But would it combine the 1961 deciphering of the genetic code by Marshall Nirenberg and Heinrich Matthaei in a “Glimpse of History” boxed reading with Katalin Karikó and Drew Weissman’s invention of the first mRNA-based vaccine? Finally, can AI use humor? ” That definition covers all bases.

DNA 98

DNA Science Therapies Licensing 98

Eye on FDA

AUGUST 8, 2022

In February 2020 I published a blog posting – Emerging Pathogens, Communications – that encapsulated my observations and learnings from my years work in the early years of the HIV/AIDS pandemic in the early 1980s. That means there is an increasing amount of virus out there. Source: CDC. But they are all viruses.

Virus 93

Virus Nurses Vaccine Hospitals 93

NIH Director's Blog: Drug Development

MARCH 18, 2021

He uses these fundamental insights to guide the design of vaccines and therapeutics, including promising monoclonal antibodies. These days, the Veesler lab has been hard at work to understand SARS-CoV-2 and the human immune response to the virus. Despite carrying all of these viruses, bats rarely show symptoms of being sick.

Virus 52

Virus Immune Response Clinical Trials Treatment 52

Codon

MAY 22, 2023

Read A chikungunya vaccine induced high levels of neutralizing antibodies in a phase II trial. One paper estimates that the entirety of human-created mass (half of which is concrete) probably reached the total weight of Earth’s entire biomass — every tree, bacterium, virus, and whale — in 2020. Nature Communications.

DNA 61

DNA Engineering Science Trials 61

The Pharma Data

MAY 14, 2021

There is specific, step-by-step natural ways to. get rid of pain, itchiness, strengthen your body’s immune system and recovering. capabilities, and allow your body to fight off this virus faster and more. efficiently. I learned A LOT about the virus, but not. about this virus and wanted to understand it more.

Treatment 52

Treatment Doctors Virus Vaccine 52

Codon

MARCH 12, 2023

Base editor proteins were delivered into the mice using a virus, called AAV9. coli genes into a piece of simian virus DNA. The landmark paper enabled revolutions in insulin biomanufacturing, CAR-T therapies, and the bioproduction of most modern vaccines; in other words, much of what we take for granted today.

DNA 52

DNA Engineering Therapies RNA 52

Codon

MAY 22, 2023

Read A chikungunya vaccine induced high levels of neutralizing antibodies in a phase II trial. One paper estimates that the entirety of human-created mass (half of which is concrete) probably reached the total weight of Earth’s entire biomass — every tree, bacterium, virus, and whale — in 2020. Nature Communications.

DNA 52

DNA Engineering Science Trials 52

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 52

Virus Clinical Trials Engineering Treatment 52

PPD

NOVEMBER 8, 2022

In the third year of the COVID-19 pandemic, we also see the virus’s lingering effect on industry operations. The approval of mRNA-based COVID-19 vaccines was a key step in reifying a mainstream future for novel therapeutic platforms, including other nucleic acid therapeutics and cell and gene therapies.

Clinical Trials 52

Clinical Trials Trials Drug Development Clinical Research 52

Codon

MAY 18, 2023

link ) An mRNA vaccine for many types of flu viruses is now in a phase I clinical trial. No more designing new flu vaccines each year? Scientists removed Ashanti’s blood cells and inserted a functional copy of the ADA gene via a virus. They are mainly using epigenetic editing to explore aging, and how to roll it back.

DNA 52

DNA Therapies Engineering Virus 52

Codon

MAY 18, 2023

link ) An mRNA vaccine for many types of flu viruses is now in a phase I clinical trial. No more designing new flu vaccines each year? Scientists removed Ashanti’s blood cells and inserted a functional copy of the ADA gene via a virus. They are mainly using epigenetic editing to explore aging, and how to roll it back.

DNA 52

DNA Therapies Engineering Virus 52

PerkinElmer

FEBRUARY 28, 2022

Fast-forward to today, and thousands of scientists have turned their attention to studying SARS-CoV-2, the virus responsible for the current COVID-19 pandemic. This research pivot led to a torrent of scientific papers describing the structure and biology of the virus being published. μl of ATPlite-substrate per well. 2021;102(4).

Virus 52

Virus Vaccine Clinical Trials Hospitals 52

Codon

MAY 11, 2023

3/ A Vaccine for RSV A vaccine called Arexvy, and marketed by GlaxoSmithKline, has been approved by the FDA for adults aged 60 and older. It is used to prevent respiratory syncytial virus, or RSV, which causes about 60,000 hospitalizations in this age group each year. The vaccine was 82.6 The vaccine was 82.6

Vaccine 52

Vaccine Engineering Licensing Licensing 52

Codon

MAY 11, 2023

3/ A Vaccine for RSV A vaccine called Arexvy, and marketed by GlaxoSmithKline, has been approved by the FDA for adults aged 60 and older. It is used to prevent respiratory syncytial virus, or RSV, which causes about 60,000 hospitalizations in this age group each year. The vaccine was 82.6 The vaccine was 82.6

Vaccine 52

Vaccine Engineering Licensing Licensing 52