Broad Institute

AUGUST 7, 2024

They first used an initial round of machine learning modeling to generate a new moderately sized library, called Fit4Function, that contained capsids that were predicted to package gene cargo well. The team screened the library in human cells and mice to find capsids that had specific functions important for gene therapy in each species.

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Alta Sciences

SEPTEMBER 20, 2023

AnQlar is a nanoparticle intended to help prevent the spread of negatively charged viruses such as COVID-19 and influenza via intranasal spray, and has been shown to inhibit the ability of the virus to replicate at non-toxic concentrations. We look forward to further collaboration with Virpax in the near-future.”

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

The FDA-approved Package Insert describes the “main efficacy outcome” as being “a non-inferiority test of annualized bleeding rate (ABR) during Months 7 to 18” as compared to the ABR during the lead-in period. At the same time, it is understandably important to be able to measure and characterize a treatment’s effect over time.

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The Pharma Data

AUGUST 7, 2020

CluePoints provides clinical studies with risk management support package during Covid-19. Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, said: “The response to our complimentary risk assessment package has been fantastic.

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Broad Institute

SEPTEMBER 13, 2023

But researchers have struggled to design molecular vehicles that can deliver gene-based therapies safely and effectively to the right cells. Scientists at the Broad Institute are tackling this problem using a variety of delivery strategies.

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The Pharma Data

JANUARY 6, 2021

1 and 20 will be automatically entered to win the “Big Game at Home” package for viewing at home, with a 65-inch television and a $500 gift card. People who have recovered from COVID-19 may have antibodies in their plasma that could give a patient’s immune system the boost it needs to beat the virus. © 2021 HealthDay.

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Drug Target Review

DECEMBER 5, 2024

Challenges of viral capsids in gene therapy efficiency A widely used production method of rAAV vectors requires co-transfection of host cell lines with three plasmids, including one carrying the transgene of interest, one carrying the capsid and replication sequences, and a helper virus to circumvent the inability of rAAV to self-amplify.

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The Pharma Data

OCTOBER 28, 2020

In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

NOVEMBER 22, 2020

Pfizer has designed its own packaging using dry ice that can be stored for weeks without the specialized freezers. They use mRNA that codes for the spike protein in the SARS-CoV-2 virus, which is embedded in a nanolipid particle—basically a minuscule fat molecule. Both the Pfizer-BioNTech and Moderna vaccines utilize mRNA technology.

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The Premier Consulting Blog

MARCH 7, 2024

The analytical package, consisting of release, stability, and characterization tests, includes data generated throughout the product development and manufacturing process. For gene therapy vectors, this testing encompasses production cell lines, master and working cell banks (MCB, WCB), and virus banks.

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The Pharma Data

OCTOBER 19, 2020

Spectrum’s self-contained saliva collection kit provides critical sample consistency while suspending and neutralizing viral RNA transcripts completely inactivating the live virus. A single-source provider of on-site medical device development and manufacturing, custom packaging, kitting, and direct-to-consumer fulfillment.

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The Pharma Data

OCTOBER 25, 2020

Costume contact lens packaging that claims “one-size-fits-all” or “no need to see an eye doctor” is false, the academy said. SUNDAY, Oct. Poorly fitted contact lenses can scrape the cornea (the outer layer of the eye), making the eye more vulnerable to bacteria and viruses that can cause infections.

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Molecular Design

AUGUST 9, 2020

There are three general approaches to directly tackle a virus such as SARS-CoV-2 with a small molecule drug (or chemical agent). First, destroy the virus before it even sees a host cell and this is the objective of hand-washing and disinfection of surfaces.

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The Pharma Data

MARCH 20, 2021

Historically, cell culture was the mainstay of viral antigen detection, and it still remains necessary to a minor degree, because it is the only technique capable of providing a viable isolate that can be used for further characterization of the virus. INTRODUCTION.

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The Pharma Data

AUGUST 24, 2020

The Head of the National Health Commission’s Science and Technology Centre, Zheng Zhongwei, said: “We’ve drawn up a series of plan packages, including medical consent forms, side effect monitoring plans, rescuing plans, compensation plans, to make sure the emergency use is well regulated and monitored.”. Conor Kavanagh.

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The Pharma Data

OCTOBER 30, 2020

About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

SEPTEMBER 1, 2020

This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes. SARS-CoV-2 Rapid Antigen Test package insert [2] European Centre for Disease Prevention and Control. At launch, there will be 40 million SARS-CoV-2 Rapid Tests available, per month.

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NIH Director's Blog: Drug Discovery

MARCH 8, 2016

Instead of the black, printed stripes of the Universal Product Codes (UPCs) that we see on everything from package deliveries to clothing tags, they used short, unique snippets of DNA to label cells. A little more than a decade ago, researchers began adapting a familiar commercial concept to genomics: the barcode.

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The Pharma Data

OCTOBER 14, 2020

The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19. The research encompasses two projects. The study led by Dr. Ilya Trakht, Ph.D., About TNX-1800.

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Agency IQ

JULY 13, 2023

Each of these re-authorizations, along with provisions in other, related legislative packages such as the 21 st Century Cures Act , sought to add to, tweak and/or amend the U.S. The House PAHPRA reauthorization package does include some interesting provisions. public health emergency preparedness and response infrastructure.

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The Pharma Data

JUNE 25, 2021

“These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. Variant Virus Strains. against the original virus strain, 86.3% It is packaged in a ready-to-use liquid formulation in 10-dose vials. Glenn, M.D.,

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Agency IQ

JULY 26, 2024

This includes the submission of OMORs, public comments to administrative orders, formal meeting requests and packages, dispute resolution requests, administrative hearing requests, record request responses, as well as updates to drug listing information. What should be submitted to which portal?

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The Pharma Data

DECEMBER 17, 2020

About casirivimab and imdevimab Casirivimab and imdevimab (formerly known as REGN-COV2 or REGEN-COV2) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

NOVEMBER 5, 2020

Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. (..)

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Agency IQ

JANUARY 12, 2024

The data used by AgencyIQ is obtained from reports put out by CDER and CBER , as well as approval letters and review packages posted to the Drugs@FDA database. While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved.

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The Pharma Data

DECEMBER 5, 2020

Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. (..)

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Broad Institute

JANUARY 14, 2025

Building on previous work by the vector-engineering lab of Ben Deverman at the Broad, the team developed a pair of adeno-associated viruses (AAVs) to package and deliver the base-editing machinery to brain cells. But the researchers needed to deliver the base editors to the brain.

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Broad Institute

JUNE 27, 2024

They used an engineered adeno-associated virus (AAV) that crosses the blood-brain barrier after intravenous administration. The first problem they had to tackle was the editor’s size, because the editor needs to be small enough to be packaged and delivered to specific cells in the body.

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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.

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The Pharma Data

JANUARY 12, 2021

. “Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D. Yancopoulos , M.D.,

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The Pharma Data

DECEMBER 16, 2020

Gustave Perna, who oversees the logistics for Operation Warp Speed, told reporters earlier this week that McKesson will package and distribute the vaccine to more than 3,000 sites across the country. The technology leveraged to create the vaccine does not require the actual virus, according to CNN.

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The Pharma Data

JANUARY 6, 2021

We hope this effective, well-tolerated and simple-to-administer vaccine will now begin to have a real impact on this deadly virus. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

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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.

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The Pharma Data

MARCH 25, 2021

TAK-003 is Being Studied for the Prevention of Dengue Due to any Dengue Virus Serotype in Individuals Ages Four to 60. Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses. About TAK-003.

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Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. If you want to edit a gene inside of a neuron, what do you do? These viruses enter the brain and deliver the gene-editing ingredients into neurons.

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Vaccine DNA Virus Engineering 52

Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. If you want to edit a gene inside of a neuron, what do you do? These viruses enter the brain and deliver the gene-editing ingredients into neurons.

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Vaccine DNA Virus Engineering 52

Drug Target Review

MAY 22, 2024

In parallel, we are exploring the technical performance of circVec in other viral vectors, as well as non-viral approaches which we expect will surpass virus-based vector-format as the state-of-the-art solutions for gene therapy in the future. We are now running follow-up experiments to track the advantage long-term.

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