pharmaphorum

MAY 24, 2022

Monkeypox is considered less likely to mutate quickly because it is a DNA virus rather than an RNA virus like influenza or COVID-19. ” Vaccines and drugs are available. There’s also a licensed antiviral drug for monkeypox. The US FDA also approved a new intravenous form of the drug last week.

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Pfizer

DECEMBER 13, 2022

In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID for patients who are at high risk of progression to severe disease from COVID-19. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in February 2023.

Drugs 110

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pharmaphorum

DECEMBER 21, 2020

Their technology is based on synthetic messenger RNA – short for ribose nucleic acid – which is a short transcript of a longer DNA code. Its portfolio of products was broad – including a drug being developed with AstraZeneca for cardiovascular diseases, a cancer immunotherapy and a potential Zika vaccine. “I

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Drug Discovery World

MARCH 7, 2023

For International Women’s Day, DDW’s Diana Spencer celebrates some of the women in leadership making an impact on the drug discovery and life sciences sector. She has over 15 years’ experience in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing.

Life Science 98

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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. TITUSVILLE, N.J. , 50 c/mL, meeting noninferiority criteria.

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Pfizer

JANUARY 27, 2023

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. Sufficient information is not available to assess for a potential drug interaction.

Marketing 75

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The Pharma Data

NOVEMBER 17, 2021

Food and Drug Administration (FDA) includes clinical data from the Phase2/3 EPIC-HR ( Evaluation of Protease Inhibition for COVID-19 in High- Threat Cases) interim analysis. PF-07321332 inhibits viral replication at a stage known as proteolysis, which occurs before viral RNA replication. This submission to theU.S.

HR 52

HR Manufacturing Contract Manufacturing Licensing 52

Pfizer

AUGUST 15, 2022

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. AUTHORIZED USE.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

The Pharma Data

MARCH 22, 2022

Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

In-Vitro 52

In-Vitro Contract Manufacturing Manufacturing Production 52

Pfizer

NOVEMBER 23, 2022

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g.,

Licensing 40

Licensing Licensing Drugs Manufacturing 40

Drug Discovery World

SEPTEMBER 6, 2022

There’s no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. Among these include Zolgensma, Novartis’ gene therapy drug for spinal muscular atrophy (SMA), which made headlines in the UK for its £1.79 million price point per dose. Despite this the industry is still expanding.

Gene Therapy 52

Gene Therapy Gene Manufacturing Medicine 52

XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion the drug generated in 2021. billion in 2022. billion, a 26.55

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

APRIL 30, 2021

Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for Skyrizi (risankizumab, 150 mg) for the treatment of adults with active psoriatic arthritis (PsA). The updated Prescription Drug User Fee Act (PDUFA) action dates have been extended three months to late 2Q 2021 for PsA and early 3Q 2021 for AD.

Botox 40

Botox Production Development Cosmetics 40

The Pharma Data

AUGUST 3, 2021

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Business Development/Other Developments.

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