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.

Therapies 137

Therapies FDA Approval Engineering Disease 137

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 Molecular Biology FDA Virus 52

The Pharma Data

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.

FDA Approval 52

FDA Approval Treatment FDA Clinical Trials 52

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.

FDA Approval 52

FDA Approval FDA Virus Drugs 52

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S. in 1-15 year olds and 98.7-100%

FDA Approval 52

FDA Approval Vaccine FDA Virus 52

PerkinElmer

APRIL 21, 2020

Although the novel coronavirus is the subject of nearly every media story right now, several years ago it was the Zika virus (ZIKV) gathering a great deal of attention. Here, we describe the novel use of high content imaging solutions (HCS) in a study to identify possible Zika virus inhibitors that could be translated into therapeutic form.

Virus 52

Virus FDA Approval Laboratories Vaccine 52

PerkinElmer

AUGUST 13, 2020

The virus, which can cause a severe form of pneumonia and lead to acute respiratory distress, currently has no FDA-approved targeted therapeutic or vaccine. For this reason, researchers around the globe are scrambling to understand this novel virus and figure out its potentially targetable vulnerabilities.

Virus 52

Virus Cell Based Assays FDA Approval Clinical Trials 52

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.

FDA Approval 52

FDA Approval Therapies FDA Disease 52

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.

Pharmacogenetics 100

Pharmacogenetics Pharmacokinetics FDA Approval Virus 100

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.

FDA Approval 52

FDA Approval Treatment FDA Hospitals 52

Broad Institute

APRIL 25, 2024

It can take only 36 hours for a virus that is emerging in a very remote place to find itself in New York or Paris — they are just a few flights away,” Happi said. Since 2007, they’d been studying Lassa fever, an often deadly illness caused by infection with the Lassa virus, which is endemic in West Africa.

Virus 132

Virus Hospitals Disease Government 132

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.

FDA Approval 52

FDA Approval FDA Nurses Virus 52

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

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.

FDA Approval 52

FDA Approval FDA Government Virus 52

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.

Therapies 119

Therapies FDA FDA Approval Treatment 119

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 94

RNA Virus DNA Vaccine 94

The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. 1) “Great advancements have been made in the fight against COVID-19, yet the virus remains a present and unpredictable concern. NYSE: PFE) announced today that the U.S. More than 11.6

FDA Approval 40

FDA Approval FDA Hospitals Vaccine 40

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.

Therapies 98

Therapies Research Engineering Virus 98

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.

FDA Approval 52

FDA Approval FDA Clinical Development Virus 52

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.

FDA Approval 52

FDA Approval FDA Virus Disease 52

Broad Institute

FEBRUARY 8, 2024

By Allessandra DiCorato February 8, 2024 Credit: NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland Scanning electron image of the Lassa virus budding off a cell. Other scientists had discovered that this gene was critical for the Lassa virus to enter cells. Finding participants for the study would be challenging too.

Research 81

Research Virus Hospitals Disease 81

The Pharma Data

NOVEMBER 23, 2021

Approval is for Cytomegalovirus, a Type of Herpes Virus. Livtencity works by preventing the activity of human cytomegalovirus enzyme pUL97, thus blocking virus replication. director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. Today, the U.S.

FDA Approval 52

FDA Approval Treatment FDA DNA 52

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.”

Virus 40

Virus Clinical Pharmacology Drugs FDA Approval 40

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.

Virus 52

Virus FDA Approval Clinical Trials Trials 52

EG Life Sciences

FEBRUARY 15, 2023

The US Food and Drug Administration (FDA) approved around 26 novel drugs in 2022. Approval processes were slow in comparison to 2020 and 2021, where 53 and 50 approvals were achieved respectively. Going into the third year of the pandemic, we know that the virus still impacts industry operations.

Drug Development 52

Drug Development FDA Approval Drugs Virus 52

The Pharma Data

SEPTEMBER 11, 2020

60,000 people across Britain may have been suffering from prolonged symptoms of coronavirus months after contracting the virus. Genetech scores sixth FDA approval in lung cancer with Gavreto. FDA approves GlaxoSmithKline’s Trelegy for treating asthma.

FDA Approval 52

FDA Approval Vaccine Clinical Trials FDA 52

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.

Therapies 52

Therapies Virus DNA Compliance 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

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.

Virus 52

Virus Drugs FDA Approval FDA 52

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.

Virus 40

Virus Trials Clinical Trials Production 40

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. Both vaccines have shown about 95% efficacy in preventing novel coronavirus infections.

Vaccine 52

Vaccine Immune Response FDA FDA Approval 52

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.

FDA 52

FDA FDA Approval Laboratories Doctors 52

The Pharma Data

FEBRUARY 23, 2022

For laboratory workers: TBE vaccination is recommended for those with a potential exposure to the TBE virus (TBEV). Food and Drug Administration (FDA) approved TicoVac™ for active immunization to prevent TBE in individuals 1 year of age and older. 1 TicoVac™ is the only FDA-approved vaccine to help protect U.S.

Vaccine 52

Vaccine FDA Approval Laboratories Virus 52

The Pharma Data

NOVEMBER 17, 2021

The precise mechanism of the drug against SARS-CoV-2 is not yet known, but researchers have hypothesized that it may prevent the virus from taking hold by interfering with an enzyme it requires to replicate. If disulfiram’s effect against SARS-CoV-2 is confirmed, it could become a useful tool against the virus. A Pandemic Pivot.

Virus 52

Virus Drugs Clinical Trials Medical Schools 52

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.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

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.

Vaccine 52

Vaccine Clinical Trials Virus Trials 52

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.

Therapies 52

Therapies Research Engineering Clinical Research 52