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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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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XTalks

FEBRUARY 5, 2024

The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Price of Revlimid: A supply of 28 oral 2.5 mg capsules is $24,576.

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pharmaphorum

NOVEMBER 5, 2021

Novartis has chalked up another successful trial for its targeted factor B inhibitor iptacopan, an orally-active drug trying to challenge antibody-based therapies for diseases associated with the complement pathway. billion in peak annual sales if it gets approved for all its target indications.

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Trials Protein Antibody FDA Approval 105

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

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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pharmaphorum

JULY 13, 2021

The Danish drugmaker is paying $100 million upfront for rights to antibody drug PRX004, which is heading for phase 2 trials in cardiomyopathy associated with ATTR amyloidosis, a life-threatening disease affecting the heart and nervous system. According to analysts at GlobalData – sales are set to rocket to $3.5 billion by 2025.

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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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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

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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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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Marketing Antibody Drugs Sales 85

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. Approval in lupus nephritis is expected to push the product above the $1 billion threshold and into blockbuster sales territory.

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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. At its peak sales, Qalsody is expected to generate around $300 million for Biogen. How Does Qalsody Work?

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FDA Approval Gene Genetics Protein 89

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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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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Delveinsight

SEPTEMBER 8, 2021

Hydroxychloroquine and BENLYSTA are the FDA-approved therapies for SLE treatment. With the approval of these therapies, the outlook for SLE patients improved from a 4-year survival rate of ~50% in 1950 to a 15-year survival rate of ~85% by 2013. Benlysta Sales and Annual cost of therapy (ACOT). million respectively.

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Marketing Sales FDA Approval Antibody 52

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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FDA Approval Regulation Drugs Trials 52

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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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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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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Delveinsight

AUGUST 11, 2020

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. Under the terms of the agreement, Verastem will receive an up-front amount of USD 70 Million, with a total deal value of up to USD 311 Million and royalties on sales.

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Clinical Trials Clinical Trials Trials Protein 52

The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). Product Sales Performance. Key results include: Total revenues increased 5% to $6.5

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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

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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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

The Pharma Data

OCTOBER 30, 2020

NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc. Cohort 3: patients on mechanical ventilation.

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Production Antibody Manufacturing Trials 52

Delveinsight

AUGUST 10, 2021

FDA Approves Keytruda in Both Adjuvant and Neoadjuvant Setting in High-Risk Early-Stage TNBC. This approval was based on Phase III KEYNOTE-522 trial (NCT03036488) and became the first immunotherapy regimen to be approved in high-risk early-stage TNBC , marking a milestone for breast cancer patients.

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Trials FDA Approval Drugs Marketing 94

The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). TARRYTOWN, N.Y.,

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

The Pharma Data

MAY 18, 2021

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. billion in R&D and posted sales of CHF 58.3 receptors. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: [link].

Medicine 52

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The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. billion in R&D and posted sales of CHF 58.3 receptors. In 2020, Roche invested CHF 12.2

Medicine 40

Medicine In-Vitro Antibody Development 40

XTalks

MAY 31, 2023

One of its notable candidates is izokibep, a small protein inhibitor of interleukin-17A (IL-17A). Another noteworthy candidate from Acelyrin’s pipeline is lonigutamab, an anti-IGF-1R monoclonal antibody administered via subcutaneous delivery. percent of the total outstanding shares of Kenvue’s common stock (or 89.6

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Clinical Trials Clinical Trials Trials Production 97

The Pharma Data

NOVEMBER 21, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. government allocation program. Regeneron Pharmaceuticals, Inc.

Antibody 40

Antibody Production Clinical Trials Clinical Trials 40

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

APRIL 27, 2021

Q1 2021 sales increase of 2.4% Specialty Care sales grew 15.3%, due to strong Dupixent ® performance (+45.6% General Medicines core assets grew 4.4%, while GBU sales were down 3.8%. Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. IFRS net sales reported.

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Sales Vaccination Vaccine Medicine 52

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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The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Medicine 52

The Pharma Data

DECEMBER 15, 2020

On top of this, another 8 million carry auto-antibodies, blood molecules that indicate a person’s chance of developing an autoimmune disease. Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body. Monoclonal Antibodies.

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Clinical Trials Clinical Trials Antibody Trials 52