Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. Leqembi is currently pending approval in the EU and Japan. The FDA’s decision on Leqembi was based on data from a Phase II clinical trial named Athena AD.

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Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. Leqembi is currently pending approval in the EU and Japan. The FDA’s decision on Leqembi was based on data from a Phase II clinical trial named Athena AD.

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Delveinsight

OCTOBER 1, 2021

This disease is associated with antibodies directed against the acetylcholine receptor, muscle-specific kinase (MUSK), lipoprotein-related protein 4 (LRP4), or agrin in the postsynaptic membrane at the neuromuscular junction. Myasthenia Gravis Approved Therapies. Some of the approved drugs are: Prograf (Tacrolimus).

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Pharmaceutical Technology

AUGUST 23, 2022

It comprises messenger ribonucleic acid (mRNA) that encodes for the initial spike protein of SARS-CoV-2 along with mRNA that encodes for Omicron BA.4/BA.5 5 variant spike protein. According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1,

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Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. One strategy proposed the use of synthetic mRNA or modified mRNA analogs, which can enhance the stability and protein expression of mRNA.

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Drug Discovery World

AUGUST 24, 2023

The European Commission (EC) has granted conditional marketing authorisation (CMA) for Janssen’s Talvey (talquetamab) as monotherapy for relapsed and refractory multiple myeloma (RRMM).

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The Pharma Data

DECEMBER 17, 2020

Lupus causes the production of proteins called autoantibodies in the immune system, which attack tissues and organs, including the kidneys. There will be a brand-new treatment for actinic keratosis on the market next year, with Tuesday’s FDA approval of Athenix’s Klisyri® (tirbanibulin). at the time of the announcement.

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization.

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XTalks

JUNE 30, 2023

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The approval came after a couple of setbacks, including a rejection in 2020 and a delay earlier this year. The disorder primarily affects males.

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XTalks

MAY 1, 2023

Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins. Tegoprubart is an anti-CD40L antibody designed to inhibit the CD40 and CD11 costimulatory signaling pathways. How Does Qalsody Work?

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FDA Approval Gene Genetics Protein 89

XTalks

MARCH 6, 2024

Despite the disappointing launch of Aduhelm and questions around Leqembi, companies like Eli Lilly are continuing to pursue their beta-amyloid monoclonal antibody therapies. Lilly is currently conducting a Phase III trial evaluating its beta-amyloid targeting monoclonal antibody, donanemab.

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The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

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pharmaphorum

JUNE 22, 2021

GlaxoSmithKline (GSK) has reported encouraging data for its COVID-19 antibody sotrovimab, and an alliance with Halozyme to develop a new generation of long-acting HIV drugs, as it prepares to give a much-anticipated update to shareholders tomorrow. So far, all the other antibodies are also delivered by intravenous infusion.

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Pharmaceutical Technology

NOVEMBER 9, 2022

In August 2020, the agency had rejected an approval application, suggesting the company complete its Phase III Gener8-1 study and include two-year follow-up safety and efficacy data. In the EU however, two years later, the European Commission awarded a conditional marketing authorisation for Roctavian. million ($1.5 million ($1.8

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XTalks

APRIL 18, 2024

The Elecsys pTau217 assay is designed to detect amyloid pathology, a hallmark of Alzheimer’s disease, by measuring phosphorylated tau protein in human plasma. There are currently no FDA-authorized blood tests for detecting Alzheimer’s disease. The company’s Precivity blood tests detect both amyloid beta and tau proteins.

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pharmaphorum

DECEMBER 18, 2020

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. The anti-CD20 mechanism could also lead to some competition for GSK in SLE and lupus nephritis.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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XTalks

FEBRUARY 26, 2024

Xolair is the first medication approved by the FDA to reduce allergic reactions to more than one type of food after accidental exposure. Xolair is a monoclonal antibody that binds to IgE, a type of antibody in the body that triggers allergic reactions, to block it from binding to its receptors.

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XTalks

FEBRUARY 5, 2024

As we delve into the specifics of these best-selling oncology drugs, we uncover the underlying factors contributing to their market dominance, from clinical efficacy and safety profiles to strategic market positioning and patient accessibility. Price of Revlimid: A supply of 28 oral 2.5 mg capsules is $24,576.

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pharmaphorum

MARCH 21, 2022

Bristol-Myers Squibb has won FDA approval for the first LAG-3 inhibitor drug ahead of its rivals in cancer immunotherapy including Merck & Co. Like PD-1, LAG-3 is a negative regulator of T cells, suppressing their activity against cancer cells, so when that brake is released the immune system can attack and kill tumours.

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The Pharma Data

DECEMBER 5, 2020

(NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells.

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Delveinsight

AUGUST 11, 2020

Roche Set to Compete With Biogen and Novartis in the SMA Market With its First Oral Therapy . It is a survival motor neuron-2 (SMN-2) splicing modifier, designed to increase and sustain SMN protein levels throughout the central nervous system and peripheral tissues. The drug showed improvement in both the trials.

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The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

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pharmaphorum

APRIL 8, 2021

Trodelvy is an antibody-drug conjugate (ADC) that works by latching onto a protein called TROP-2 that is found on cancer cells in triple-negative breast cancer and killing them with a toxic payload. The drug is also under review in the EU and in the United Kingdom, Canada, Switzerland and Australia.

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Drugs FDA Approval Protein Antibody 101

Delveinsight

AUGUST 4, 2020

MorphoSys, Incyte gets an early FDA nod for Monjuvi, an alternative to CAR-T for B-cell malignancies. Not long ago, the companies inked an oncology pact to develop and commercialize MorphoSys’ anti-CD19 antibody Monjuvi jointly. Billion deal in a thirst to grow in the cancer market.

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XTalks

OCTOBER 25, 2022

Imjudo is an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) monoclonal antibody that blocks the action of CTLA-4. Inhibition of the protein aids in T-cell activation to prime the immune system against cancer cells to induce their death.

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Drug Discovery World

OCTOBER 4, 2022

New York-based Oligomerix is an emerging clinical-stage biotechnology company focused on developing disease-modifying therapeutics for neurodegenerative diseases characterised by aberrant tau protein ranging from rare tauopathies such as progressive supranuclear palsy (PSP) and frontotemporal dementia (FTD) to Alzheimer’s disease (AD).

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The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. Cornering the untapped Chinese CNS market, SciNeuro launched with $100 million in their pocket. Reduce cost. Nuance Pharma .

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RNA Antibody Life Science Protein 52

XTalks

FEBRUARY 5, 2024

As we delve into the specifics of these best-selling oncology drugs, we uncover the underlying factors contributing to their market dominance, from clinical efficacy and safety profiles to strategic market positioning and patient accessibility. Price of Revlimid: A supply of 28 oral 2.5 mg capsules is $24,576.

FDA Approval 52

FDA Approval Drugs Sales Development 52

XTalks

MAY 25, 2021

AbbVie (NYSE:ABBV) continues to face heat over complaints of patent exploitation and price hikes of its world’s best-selling drug Humira (adalimumab) to build a market monopoly and block out Humira biosimilar competition. According to the FDA, biosimilars are among the most rapidly growing class of therapeutic products in the US.

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XTalks

JUNE 5, 2023

Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains. “A In February 2023, Pfizer revealed that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for Abrysvo. percent and severe RSV-associated LRTD by 94.1

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XTalks

NOVEMBER 16, 2022

has won US Food and Drug Administration (FDA) approval for its antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. The drug was approved under the FDA’s accelerated pathway and is indicated for adult patients with folate receptor alpha (FR?)-positive

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FDA Approval Antibody Drugs Trials 98

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The goal of targeting both S and N was to both activate virus-specific T cells and generate anti-SARS-CoV-2-neutralizing antibodies. This press release features multimedia. Graphic: Business Wire).

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pharmaphorum

AUGUST 6, 2020

This is an accelerated approval based on response data and GSK may need survival data from a larger trial to keep the drug on the market in the longer term. Blenrep is also set for approval in Europe in the coming months after a positive opinion from the CHMP scientific committee at the end of last month.

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