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. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History.

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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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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 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

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. Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above.

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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 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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Agency IQ

JULY 26, 2024

Prior to CARES Act reforms, FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as they adhered to pre-set terms under the monograph. On the other hand, data, information and comments to a proposed or final order should use the OTC Monographs@FDA portal.

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The Pharma Data

DECEMBER 29, 2020

About Regeneron Antibody Cocktail Casirivimab and imdevimab 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. Casirivimab and imdevimab injection is not FDA approved for any use.

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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. Casirivimab and imdevimab injection (REGEN-COV2) is an investigational combination therapy and has been authorized by FDA for the emergency use described above.

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Codon

APRIL 2, 2023

Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Therapeutic neutralizing monoclonal antibody administration protects against lethal yellow fever virus infection. Read A really simple way to isolate AAVs, which are a type of virus often used to deliver gene therapies into cells.

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Agency IQ

JANUARY 19, 2024

The FDA CRL cited inspection findings that arose from a “multi-sponsor inspection of a third-party, contract manufacturing organization” which involved the monoclonal antibody drug substance for lebrikizumab. The clinical package, safety and label were not affected. However, BeiGene announced that it is seeking approval in the U.S.

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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. According to the FDA, a recombinant LBP is distinctive from a standard LBP. As the name suggests, a synbiotic is a product that seeks “synergy” from its contents.

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The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ ® (upadacitinib) [Package Insert]. 14 In August 2019 , RINVOQ received U.S. Some people have died from these infections. ClinicalTrials.gov. North Chicago, Ill.

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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

OCTOBER 27, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

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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

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. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. The Company expects that the U.S. Source: Moderna, Inc. . Source link.

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The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Regeneron Pharmaceuticals, Inc. Schleifer , M.D., In July 2020 , the U.S.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.

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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

They engineered genetically-encoded RNA exporters, based on viruses, that package and secrete RNA molecules in protective nanoparticles, allowing non-destructive monitoring of those RNA molecules in real-time. Today, a single injection of an FDA-approved gene therapy, called Hemgenix , cures this disease.

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Codon

FEBRUARY 23, 2025

Experimenting with a retrovirus called murine leukemia virus , he found that zidovudine did, in fact, obstruct retrovirus replication by inhibiting reverse transcriptase. Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months.

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