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 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

DECEMBER 29, 2020

All patients entering the trial were hospitalized with laboratory-confirmed COVID-19 requiring low-flow oxygen, and all received other background standard-of-care as required. Patients were randomized 1:1:1 to receive a one-time infusion of 8,000 mg of the antibody cocktail (high dose), 2,400 mg of the antibody cocktail (low dose) or placebo.

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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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addgene Blog

MAY 30, 2023

Adeno-associated virus (AAV) is a single stranded, Parvoviridae DNA virus, packaged in a non-enveloped icosahedral capsid, that can be used to express genes of interest in cell and animal models. This post was contributed by guest blogger Didem Goz Ayturk with edits and updates from Addgenies Karen Guerin and Susanna Stroik.

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Drug Discovery World

JULY 18, 2023

For instance, virus-free approaches have been applied using CRISPR-Cas mediated homology-directed repair (HDR) to efficiently insert CARs into the TRAC locus of primary human T cells 7 , thereby improving their functionality. CRISPR diagnostics have successfully detected various pathogens, including RNA viruses (eg.

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Agency IQ

JANUARY 19, 2024

While some biologic developers may choose to develop new cell lines in-house, given the extensive resources required to do so, it is common for researchers and/or sponsors to acquire cell seeds from outside laboratories or cell banks. First, viral contaminants may be introduced from starting materials.

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The Pharma Data

JUNE 18, 2021

Tears in the stomach or intestines and changes in certain laboratory tests can happen. RINVOQ ® (upadacitinib) [Package Insert]. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay. Some people have died from these infections. ClinicalTrials.gov. AbbVie Inc.

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The Pharma Data

MARCH 20, 2021

Accurate and timely laboratory diagnosis of COVID-19 is one of the most pivotal requirements for optimal disease management and contact tracing. The vast majority of current laboratory testing for COVID-19 is based either on detection of viral antigens, nucleic acids or on detection of virus-specific antibodies in the sera of patients.

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The Pharma Data

DECEMBER 5, 2020

Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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Agency IQ

NOVEMBER 3, 2023

The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. And last week, the FDA released a warning letter sent to Abbott Laboratories for marketing its Similac Probiotic Tri-Blend for premature infants.

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Codon

JULY 27, 2023

A new paper from Michael Elowitz’s group at Caltech reports engineered RNA exporters that “efficiently and specifically package and secrete target RNA molecules from mammalian cells within protective nanoparticles.” A YouTuber, The Thought Emporium , is growing rat neurons in the laboratory. No longer. mycoides cell.

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Codon

JULY 27, 2023

A new paper from Michael Elowitz’s group at Caltech reports engineered RNA exporters that “efficiently and specifically package and secrete target RNA molecules from mammalian cells within protective nanoparticles.” A YouTuber, The Thought Emporium , is growing rat neurons in the laboratory. No longer. mycoides cell.

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The Pharma Data

FEBRUARY 22, 2021

Tears in the stomach or intestines and changes in certain laboratory tests can happen. RINVOQ (upadacitinib) [Package Insert]. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay. Some people have died from these infections. ClinicalTrials.gov. AbbVie Inc.

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The Pharma Data

NOVEMBER 5, 2020

“Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.

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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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Codon

APRIL 2, 2023

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Nature Neuroscience. Read You love to see it! Nature Biotechnology. Ricciardi M.J.

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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.

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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. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

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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. Hepatotoxicity: Hepatic adverse events were reported.

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The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. The Company expects that the U.S. on October 22, including those at high risk of severe complications of COVID-19 disease.

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Agency IQ

OCTOBER 27, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

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Codon

JUNE 26, 2023

This reminds me of the Chemputer , “an autonomous compiler and robotic laboratory platform to synthesize organic compounds on the basis of standardized methods descriptions,” that was reported back in 2019. A phage is a virus that infects bacteria. It was used to make catalysts, a dye, and an insect repellant. in Nature.

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Codon

JUNE 26, 2023

This reminds me of the Chemputer , “an autonomous compiler and robotic laboratory platform to synthesize organic compounds on the basis of standardized methods descriptions,” that was reported back in 2019. A phage is a virus that infects bacteria. It was used to make catalysts, a dye, and an insect repellant. in Nature.

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The Pharma Data

OCTOBER 14, 2020

The three antibodies help neutralize the Ebola virus by blocking its ability to invade patients’ and/or enlisting other immune cells to target infected cells and remove them from the body. Selected grade 3 and 4 laboratory abnormalities for Inmazeb included high sodium (? mmol/L), low potassium (< 2.5

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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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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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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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Drug & Device Law

JULY 31, 2023

Smith rejected plaintiff’s analogy between books and drug package inserts. May 13, 2015) (contract involving multiple, identical “software package[s]” governed by UCC). From these exercises we concluded that a 50-state survey on intangibles as “products” for product liability purposes would be both doable and useful. 1145, 1165 n.135

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