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. Related: AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer. The drug is approved in seven different types of cancer and the sales hit $2 billion in 2021 from $1.7

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FDA Approval Trials Immune Response Drugs 98

XTalks

JULY 14, 2022

Over time, even the use of Krystexxa can lead to the development of antibodies against it, reducing its effectiveness. Early data also showed that methotrexate could prevent the formation of anti-drug antibodies. Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults.

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FDA Approval Antibody Trials Drugs 105

XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

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FDA Approval Manufacturing Trials Clinical Trials 52

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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FDA Approval Drugs Sales Development 52

XTalks

DECEMBER 10, 2021

Zavegepant is an antibody drug that prevents binding of the calcitonin gene-related peptide (CGRP) to the CGRP receptor. CGRP receptor antagonists are a new class of antibody drugs used for migraine treatment. In the third quarter of 2021, Nurtec sales totalled $136 million , a 46 percent jump from the previous quarter.

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FDA Approval Trials Drugs Sales 98

XTalks

MAY 29, 2024

The multiple myeloma drug recently received US Food and Drug Administration (FDA) approval in earlier treatment settings. Products like electrophysiology devices, contact lenses and surgical products were major drivers of sales in this area. billion on R&D in 2023, representing almost 18 percent of the year’s sales.

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Pharma Companies Sales FDA Approval Vaccination 52

XTalks

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. billion in sales from HER2-low patients alone by 2030 based on the strong trial data.

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FDA Approval HR Hormones Antibody 98

XTalks

JANUARY 9, 2023

The US Food and Drug Administration (FDA) granted Roche’s Lunsumio (mosunetuzumab) an accelerated approval near the end of 2022 for the treatment of adult patients with relapsed or refractory follicular lymphoma. It was approved in the EU for the same indication in June last year.

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FDA Approval Gene Therapy Antibody Gene 98

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. billion in pharmaceutical sales from 2021. billion in 2022, a 23.43

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Sales Manufacturing FDA Approval Life Science 98

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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Drugs FDA Approval Sales Vaccination 52

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. billion in peak annual sales of Roctavian.

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Gene Therapy Gene FDA Approval Antibody 98

XTalks

JANUARY 4, 2024

The adeno-associated viral (AAV) vector-based gene therapy received approval in Canada for the treatment of adults aged 18 years or older with moderately-severe to severe hemophilia B who are negative for neutralizing antibodies to variant AAV serotype Rh74, Pfizer Canada revealed in its announcement of the approval.

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Gene Therapy Gene Gene Editing Sales 111

XTalks

FEBRUARY 5, 2024

GSK declared Arexvy to be a blockbuster in its first year on the market after higher-than-expected sales. GSK revealed in its 2023 annual and quarterly earnings report last week that sales of Arexvy totaled $1.5 GSK said it has secured about two-thirds share of the US market where nearly all of Arexvy’s sales were recorded.

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Vaccination Vaccine Marketing Sales 59

XTalks

NOVEMBER 20, 2023

Truqap was reviewed under the FDA’s Project Orbis, which offers a framework for the concurrent submission and review of oncology drugs among international regulators. It was also given FDA priority review. Due to the restricted label, analysts at Leerink Partners lowered their estimated peak sales for Truqap from $2.36

HR 98

HR FDA Approval Gene Trials 98

XTalks

MAY 1, 2023

At its peak sales, Qalsody is expected to generate around $300 million for Biogen. New and Promising Treatments for ALS Amylyx Pharmaceuticals, a biopharmaceutical company based in Cambridge, Massachusetts, obtained FDA approval in 2022 for its oral medication Relyvrio (sodium phenylbutyrate and taurursodiol) for the treatment of ALS.

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FDA Approval Gene Genetics Protein 89

XTalks

MARCH 8, 2024

The company also complained that the FDA would make an approval decision on the biosimilar before patent expirations. According to Amgen’s last earnings report , Prolia sales increased 12 percent last year to more than $4 billion, and Xgeva’s jumped five percent from last year to $2.1

Drugs 59

Drugs FDA Approval Production Immune Response 59

XTalks

MAY 29, 2024

Pfizer has also chosen to donate the rights of royalties from sales of Bavencio (avelumab) in the US to the American Association for Cancer Research (AACR). Looking ahead, Pfizer plans to leverage its expertise in protein engineering and medicinal chemistry to further develop Seagen’s antibody-drug conjugate (ADC) technology.

Medicine 52

Medicine Marketing FDA Approval Development 52

Roots Analysis

DECEMBER 18, 2023

This novel modality emerged when pharmaceutical developers used non-antibody-based entities as targeting ligand to develop targeted therapeutics. Similar to the structure of the antibody drug conjugates, these next generation drug conjugates use a non-antibody-based targeting ligand, a cytotoxic payload and a linker.

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Drugs FDA Approval Antibody Development 40

XTalks

JUNE 12, 2023

Abbott Laboratories reported that the sales from its Diagnostics and Medical Device divisions in 2022 surpassed the company’s initial forecast. The remarkable performance in 2022 was driven largely by the sales of COVID-19 testing kits, including the BinaxNOW COVID-19 Ag test and its at-home self-test version. percent from $27.06

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FDA Approval Production Sales In-Vitro 98

pharmaphorum

SEPTEMBER 21, 2021

” Ireland is the third-largest exporter of pharmaceuticals globally, according to IDA Ireland, with 50 FDA-approved manufacturing facilities generating annual exports of around €80 billion. “This significant investment will ensure the AstraZeneca supply network is fit for the future.”

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Manufacturing Life Science FDA Approval Medicine 57

Pharmaceutical Technology

DECEMBER 22, 2022

AstraZeneca and Daiichi Sankyo win the Business Expansion award this year as their collaboration bears more fruit in terms of new approvals. The company has partnered with life sciences-focused investors Sixth Street and Royalty Pharma with an aim to bring substantial non-dilutive, low-cost capital to boost innovation and growth.

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Insulin Production Development Genetics 130

The Pharma Data

JANUARY 13, 2021

Vivity received FDA approval in February 2020. Under terms of the deal, Sirion is entitled to undisclosed upfront and milestone payments and is eligible to receive royalties on future product net sales plus license fees tied to commercial success. Cataracts are the most common cause of vision loss globally.

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XTalks

MAY 25, 2021

Biosimilar and interchangeable products can expand treatment options and lower drug and healthcare costs by offering a cheaper alternative with the same effectiveness; essentially a non-branded version of a biologic such as monoclonal antibodies, proteins and vaccines. The deal will give AbbVie unspecified royalties on Amjevita sales.

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Production Drugs Marketing Sales 98

XTalks

MAY 31, 2023

Another noteworthy candidate from Acelyrin’s pipeline is lonigutamab, an anti-IGF-1R monoclonal antibody administered via subcutaneous delivery. With an extensive product lineup, Kenvue achieved net sales of around $15 billion in 2022 , serving a broad customer base of 1.2 billion people across more than 165 countries.

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Clinical Trials Clinical Trials Trials Production 97

XTalks

AUGUST 30, 2022

Global sales of over-the-counter and prescription products related to central nervous system (CNS) disease added up to $86 billion in 2019. Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies.

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Trials Drug Delivery Drugs Gene 83

The Pharma Data

JANUARY 9, 2021

This growth primarily reflects increased sales of contract development and manufacturing (CDMO) services to pharmaceutical and biotechnology innovators and government/non-government organization (NGO) customers, as well as higher product sales. FOOTNOTES. (1) Percentage Increase at Midpoint of Range.

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Production Manufacturing Vaccination Vaccine 52

The Pharma Data

AUGUST 1, 2021

AbbVie delivered another strong quarter and our business continues to perform extremely well across the portfolio, with AbbVie’s new immunology assets contributing more than $1 billion of combined sales in the quarter,” said Richard A. Gonzalez, chairman and chief executive officer, AbbVie.

Botox 52

Botox Cosmetics Trials Clinical Trials 52