The Pharma Data

DECEMBER 16, 2020

To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA.

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The Pharma Data

DECEMBER 31, 2020

The messenger RNA (mRNA) vaccines encode a form of the spike (S) protein of SARS-CoV-2 virus. The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. FDA Approves First-In-Class Topical Klisyri to Treat Actinic Keratosis .

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Codon

APRIL 2, 2023

Read A new DNA polymerase variant, called RT-KTq I614Y, can directly detect RNA modifications, including pseudouridine (Ψ) and queuosine (Q). By combining this new variant with standard sequencing methods, it’s possible to identify RNA modifications in a really simple way. Nucleic Acids Research. Communications Biology.

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The Pharma Data

DECEMBER 18, 2020

In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material.

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The Pharma Data

JULY 29, 2021

Hepatitis B virus (“HBV”) and hepatitis delta virus (“HDV”) product sales increased 8% to $237 million for the second quarter 2021 compared to the same period in 2020. Total second quarter 2021 revenue of $6.2 Diluted Earnings Per Share (“EPS”) increased to $1.21 for the second quarter 2021 compared to net loss per share of $2.66

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The Pharma Data

NOVEMBER 16, 2020

Since early January, we have chased this virus with the intent to protect as many people around the world as possible. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. CAMBRIDGE, Mass.–(BUSINESS

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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. 50 c/mL, meeting noninferiority criteria.

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The Pharma Data

DECEMBER 10, 2020

In the study, immunization with the hAd5-COVID-19 vaccine inhibited SARS-CoV-2 virus replication in 100% (10 of 10) of Rhesus macaques, with a drop in viral replication starting on the first day of vaccine administration, and undetectable viral levels as early as three to five days post-challenge in most of the animals.

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The Pharma Data

JANUARY 31, 2021

Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

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The Pharma Data

JANUARY 12, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. CAMBRIDGE, Mass.–(BUSINESS

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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. “I

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The Pharma Data

JANUARY 6, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union. About Moderna.

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The Pharma Data

OCTOBER 21, 2020

The long-acting regimen of cabotegravir and rilpivirine is an investigational regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL). About ViiV Healthcare. Source: GSK . Posted: October 2020.

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The Pharma Data

OCTOBER 30, 2020

In October, the US Food and Drug Administration (FDA) approved the first treatment for COVID-19, Gilead’s antiviral drug Veklury (remdesivir). Previously approved under an Emergency Use Authorization (EUA), Veklury is now fully cleared for the treatment of hospitalized patients with COVID-19. 2018. .

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Codon

JANUARY 26, 2025

The influenza virus was not isolated until 1933, when an epidemic in London enabled British researchers Wilson Smith, Christopher Andrewes, and Patrick Laidlaw to collect human influenza virus from patients’ throat washings. The inoculated eggs were incubated, allowing the virus to multiply. Subscribe to Asimov Press!

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PLOS: DNA Science

DECEMBER 21, 2023

It’s a history of gene therapy told through the voices of the patients, families, researchers, and clinicians behind the first FDA approvals, which didn’t come until 2017. I am grateful to PLoS for giving me this voice for more than a decade, and free reign to cover anything that even remotely involves DNA or RNA.

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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. Promising new malaria vaccine for kids approved in Ghana. If you want to edit a gene inside of a neuron, what do you do? From Stahl E.C. in bioRxiv.

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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. Promising new malaria vaccine for kids approved in Ghana. If you want to edit a gene inside of a neuron, what do you do? From Stahl E.C. in bioRxiv.

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Codon

NOVEMBER 1, 2024

Scientists are already building a model that can, for example, look at which RNA molecules are expressed in a cell at t=0 and predict how those molecules will change at t=1. SeqFISH, developed by Long Cai’s group at Caltech, maps the spatial positions of thousands of RNA, DNA, or protein molecules within single cells.

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Codon

FEBRUARY 23, 2025

.” In 1974, Wolfram Ostertag , a German geneticist at the Max Planck Institute, explored whether zidovudine could block retroviruses , which carry RNA, and use a reverse transcriptase enzyme to convert it into DNA before integrating into the host genome. Researchers have instead focused on using antiretrovirals as preventives.

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