Broad Institute

MAY 16, 2024

But FDA-approved forms of the most commonly used vehicle for packaging and delivering these therapies to target cells, adeno-associated viruses (AAVs), aren’t able to efficiently cross the blood-brain barrier at high levels and deliver therapeutic cargo.

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JANUARY 21, 2021

Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare. “Not At the same time, the FDA approved ViiV’s New Drug Application (NDA) for Vocabria (cabotegravir) 30 mg oral tablets.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves First Over-the-Counter Fully At-Home Test for COVID-19. Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results. Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results.

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PLOS: DNA Science

JUNE 1, 2023

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). The gene treatment has been a long time coming, but it differs from the handful of other approved gene therapies: it isn’t a one-and-done. This DNA Science post from 2018 traces the history of the efforts.

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ASPET

AUGUST 8, 2024

Lenacapavir (LEN), a long-acting injectable, is the first approved human immunodeficiency virus type 1 capsid inhibitor and one of a few FDA-approved drugs that exhibit atropisomerism.

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.

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The Pharma Data

AUGUST 27, 2020

With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don’t spread the virus.” With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results.

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The Pharma Data

AUGUST 11, 2020

It has not received general approval to treat the virus in the US, but has in several European countries and Japan. The request for approval comes nearly two months after a study from the National Institute of Allergy and Infectious Diseases which showed positive results, with the drug effectively blocking the virus from replicating.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Broad Institute

JULY 19, 2023

Previous methods introduce millions of AAV capsids — the outer shells of the virus that bind to target proteins — into animals and rely on iterative rounds of screening to find AAVs that reach specific cells. Scientists have engineered adeno-associated viruses (AAVs) to package and deliver gene therapies to cells in the body.

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The Pharma Data

OCTOBER 31, 2020

TG-1000 is a novel pan-influenza antiviral, which interrupts viral replication and transmission via a cap-snatching mechanism and is able to do this effectively against influenza-A, influenza-B, avian flu H7N9, and Tamiflu-resistant viruses.

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The Pharma Data

AUGUST 31, 2020

Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Among them, more than 160,000 people did not know their HIV status, and only 53 percent were virally suppressed having low amounts of virus circulating in their blood.

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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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The Pharma Data

JANUARY 6, 2021

ONCR-177, its lead oncolytic herpes simplex virus (oHSV)-based immunotherapy, is in human trials as a monotherapy and in combination with Merck’s Keytruda (pembrolizumab) for a range of solid tumors. At least one other company is developing next-generation oncolytic virus-based immunotherapies.

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The Pharma Data

MAY 7, 2021

Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical (..)

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Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. 2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases. Labcompare.

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The Pharma Data

AUGUST 16, 2021

Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. We continuously strive to stay at least one step ahead of the virus. In the U.S.,

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The Pharma Data

APRIL 26, 2022

A drug used to treat asthma and allergies can bind to and block a crucial protein produced by the virus SARS-CoV-2, and reduce viral replication in human immune cells, according to a new study by researchers at the Indian Institute of Science (IISc). Targeting Nsp1 could therefore reduce the damage inflicted by the virus.

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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

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

DECEMBER 15, 2020

” Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results. The new Ellume COVID-19 Home Test approved Tuesday detects SARS-CoV-2 virus protein fragments on nasal swab samples from any person 2 years of age or older, according to the FDA.

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The Pharma Data

JANUARY 29, 2021

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca . Source link.

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The Pharma Data

JANUARY 29, 2021

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca. Source link.

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Advarra

AUGUST 8, 2023

As of June 2023, 416 Phase III studies are listed, representing a growing pipeline of gene therapy products preparing to undergo consideration for FDA approval. Risks and Regulatory Requirements Most clinical researchers are familiar with the regulatory requirements pertaining to the FDA phases of review as well as with IRB review.

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The Pharma Data

DECEMBER 3, 2020

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

NOVEMBER 23, 2020

Trial participants to date are aged 18 years or over, who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 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

MAY 4, 2021

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. FDA approves expanded use for Chiesi’s sickle cell drug Ferriprox ( PMLive ).

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The Pharma Data

NOVEMBER 9, 2020

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection.

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The Pharma Data

FEBRUARY 23, 2022

To evaluate the immunogenicity of the Sanofi-GSK vaccine as a booster, human immune sera samples were tested by Monogram Biosciences San Francisco, CA using an FDA-approved standardized pseudovirus neutralization test (pVNT) against the D614G prototype virus. for efficacy, immunogenicity and safety compared to a placebo.

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The Pharma Data

DECEMBER 30, 2020

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca. Source link.

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The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

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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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NIH Director's Blog: Drug Discovery

MARCH 8, 2016

Golub and colleagues produced the library by using a virus to insert a distinct DNA barcode, just 24 nucleotides long, stably into the genomes of each genetically distinct tumor cell line. The approach might also be put to use for optimizing drug candidates or for discovering new uses for cancer drugs that have already been FDA approved.

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The Pharma Data

NOVEMBER 30, 2020

About NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

JANUARY 31, 2021

If FDA approved, CONV 01-? would be the first antibody drug approved to direct a radioisotope into prostate cancer cells, and the first drug approved for the use of 225 Ac in cancer treatment. . and the results are expected to be released in Q2 2021. Leveraging the ability of CONV 01-? .

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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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