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

Vaccine 52

Vaccine RNA Clinical Trials Science 52

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.

Clinical Development 52

Clinical Development Therapies Clinical Trials Treatment 52

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

Vaccine 52

Vaccine Clinical Trials FDA Disease 52

Codon

JUNE 5, 2025

The treatment, now known as Casgevy, became the first CRISPR-based therapy to gain FDA approval, in 2023. The core of the CRISPR immune response is a guide RNA (gRNA) that binds to a CRISPR-associated (Cas) protein. Collectively, these repeat-protospacer regions are known as CRISPR arrays. Visit our website to get a copy.

DNA 81

DNA RNA Clinical Trials Engineering 81

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.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. ” The findings published today (Feb. ” The findings published today (Feb.

FDA Approval 52

FDA Approval FDA Molecular Biology Virus 52

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.

Vaccine 52

Vaccine Immune Response FDA Virus 52

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. .

FDA Approval 52

FDA Approval Hospitals Treatment FDA 52

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

Science 52

Science Production Treatment FDA Approval 52

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.

DNA 52

DNA RNA Engineering Licensing 52

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.

Vaccine 52

Vaccine FDA Clinical Trials FDA Approval 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. 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.

Vaccine 52

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. 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.

Vaccine 52

Vaccine DNA Virus Engineering 52

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

Vaccine 52

Vaccine FDA Clinical Trials Disease 52

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.

DNA 132

DNA RNA Molecular Biology Laboratories 132

Codon

AUGUST 26, 2024

After the outbreak ended, it took another three years for the first Ebola vaccine by Merck to be approved. When COVID-19 emerged in 2019, by contrast, mRNA vaccines developed by Pfizer and Moderna took just 326 days from the initial sequencing of the virus to gaining approval for emergency use.

RNA 109

RNA Virus DNA Vaccine 109

The Pharma Data

NOVEMBER 18, 2020

Lab tests that look for the coronavirus’s genetic material using a technique called polymerase chain reaction (PCR) are still considered the gold standard for detecting the virus. That fragment sets off alarms in the immune system and stimulates it to attack if the real virus shows up. “I am hopeful that it works well.”

FDA Approval 52

FDA Approval FDA Vaccine Virus 52

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 .

FDA Approval 52

FDA Approval Vaccine FDA Treatment 52

BioPharma Drive: Drug Pricing

JULY 10, 2025

Messenger RNA-based shots are especially in the spotlight, but even Novavax’s Nuvaxovid , a vaccine made with older technology, encountered delays. This panel, known as ACIP for short, recommends who should receive FDA-approved vaccines. Its guidelines influence insurance coverage.

Vaccine 226

Vaccine FDA Therapies Licensing 226

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!

Vaccine 114

Vaccine Virus Immune Response Clinical Trials 114

Codon

MAY 29, 2025

The way we typically prepare white beans completely deactivates the mild toxin that could otherwise cause food poisoning, the highly venomous cone snail that produced that shell was long gone by the time you picked it up, and Botox has been safe to inject by licensed healthcare professionals since FDA approval in 1991.

Drugs 107

Drugs DNA RNA Laboratories 107

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.

DNA 105

DNA Vaccine Science Therapies 105

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.

Clinical Trials 80

Clinical Trials Virus Vaccine DNA 80