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

pharmaphorum

AUGUST 4, 2021

Bristol-Myers Squibb’s HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial. The post Failed trial nixes another FDA approval, this time for BMS’ Istodax appeared first on.

FDA Approval 98

FDA Approval Trials Sales Marketing 98

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Brukinsa is also indicated to treat adults with Mantle cell lymphoma, Waldenström’s macroglobulinemia and relapsed or refractory marginal zone lymphoma.

FDA Approval 97

FDA Approval Life Science Clinical Trials Clinical Trials 97

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.

FDA Approval 98

FDA Approval Trials Drugs Sales 98

pharmaphorum

DECEMBER 4, 2020

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.

FDA Approval 93

FDA Approval Sales Antibody Marketing 93

pharmaphorum

OCTOBER 10, 2021

ChemoCentryx has claimed FDA approval for its avacopan drug for a rare autoimmune disease, becoming the first orally-active drug that targets the complement C5 receptor. The post Flash FDA approval sends ChemoCentryx spiralling upwards appeared first on.

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FDA Approval Drugs Pharma Companies Clinical Trials 52

Pharmaceutical Technology

SEPTEMBER 15, 2022

As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. Pfizer reaped $36.8bn from Comirnaty, the highest revenue generated from Covid-19 vaccine sales worldwide. YoY revenue growth.

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Vaccination Vaccine Sales Generic Drugs 272

Pharmaceutical Technology

FEBRUARY 8, 2023

Despite receding sales, Comirnaty, its partnered COVID-19 vaccine with BioNTech, is still forecast to reach the analyst consensus global forecast sales of $33 billion for 2022, according to GlobalData’s Drugs Database Pharma Intelligence Center. billion on Dec 31, 2022. Merck & Co. billion to $281.3 and 31.6%, respectively.

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Marketing Sales Vaccination Vaccine 195

Pharmaceutical Technology

SEPTEMBER 2, 2022

lenalidomide) + a steroid ± an anti-CD38 antibody. Last month, the European Medicines Agency's (EMA) approval of Johnson & Johnson’s (J&J) anti-CD3/BCMA bispecific antibody Tecvayli (teclistamab) marked the fourth anti-BCMA biologic to enter the R/R MM market. Should CAR-T cells, or antibodies be used first?

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Antibody Sales FDA Approval Production 147

pharmaphorum

AUGUST 2, 2021

AstraZeneca has completed the resurrection of its anifrolumab drug for systemic lupus erythematosus (SLE) after claiming FDA approval for the drug as an add-on therapy for adults with the autoimmune disease. AZ has previously said that it expects Saphnelo to also bring in $1 billion or more in sales in SLE.

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FDA Approval Drugs Sales Trials 52

XTalks

JANUARY 21, 2022

For AbbVie’s Rinvoq, the FDA approval is an expansion of its approval for the treatment of rheumatoid arthritis and psoriatic arthritis. On the other hand, this is the first US approval for Cibinqo. Dupixent has been a market hit since it was first approved by the FDA in 2017. It registered $4.4

FDA Approval 98

FDA Approval Drugs Sales Trials 98

pharmaphorum

AUGUST 17, 2020

The big Swiss pharma had been hoping for approva l in patients regardless of whether they have anti-aquaporin-4 (AQP4) antibodies. But so far Roche has not produced enough data in the broader patient group and the FDA has instead approved Enspryng in patients producing the AQP4 antibodies.

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FDA Approval Antibody Branding Trials 65

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. Basel, 17 August 2020.

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FDA Approval Antibody Clinical Trials Clinical Trials 52

Pharmaceutical Technology

DECEMBER 20, 2022

Eli Lilly saw strong global drug sales of $187m in Q3 for Mounjaro (tirzepatide), its new type 2 diabetes therapy, which was approved by the FDA in May 2022, according to GlobalData’s Drugs Database Pharma Intelligence Center. Eli Lilly was in second place, followed by Roche and Pfizer. and 10%, respectively.

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Marketing Vaccination Vaccine Sales 130

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

pharmaphorum

AUGUST 19, 2022

Takeda’s drug has been widely tipped to become the dominant option for HAE attack prevention and make blockbuster sales, and is on course to achieve that, with sales in the three months ended 30 June this year approaching $250 million. The post CSL preps filings for once-monthly antibody for HAE appeared first on.

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Antibody Sales FDA Approval Genetics 52

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

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.

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Pharmaceutical Technology

AUGUST 16, 2022

Q32 will also receive tiered royalty payments on net sales. antibody, ADX-914 re-regulates adaptive immune function by hindering IL-7 and TSLP-facilitated signalling. On Horizon exercising the option, Q32 could be entitled to further receive up to another $645m in closing and milestone payments. A fully human anti-IL-7R?

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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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FDA Approval Drugs Sales Development 101

Pharmaceutical Technology

AUGUST 16, 2022

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn. GlobalData estimates that global annual sales for datopotamab deruxtecan in the NSCLC setting will exceed $500m in 2028.

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pharmaphorum

APRIL 10, 2022

Seagen claims Enhertu (trastuzumab deruxtecan) – an antibody-drug conjugate (ADC) targeting HER2 – infringes a patient it holds (No. 10,808,039) covering ADCs that include auristatin compounds coupled to an antibody via a linker molecule. That could be a sizeable sum. billion licensing deal for the drug in 2019.

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Pharmaceutical Technology

JANUARY 19, 2023

However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000. NiCord’s biologics license application is currently being investigated by the FDA with a review date set by May 2023.

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XTalks

DECEMBER 19, 2023

As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. In this article, we will explore the factors contributing to the success of the top 20 drugs in 2023 by retail sales from the prior year. 1) Comirnaty (COVID-19 Vaccine, mRNA) Sales in 2022: $37.81

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Sales FDA Approval Drugs Vaccination 64

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

pharmaphorum

JANUARY 18, 2021

Sales of Enhertu in the US are recognised by Daiichi Sankyo. AstraZeneca reports its share of gross profit margin from Enhertu sales in the US as collaboration revenue in its financial statements. It also showed a median progression-free survival (PFS) of 5.6 months compared to 3.5 months with chemotherapy. months versus 3.9

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Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. However, non-NME and biosimilar approvals increased in 2022.

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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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Antibody Production Manufacturing Clinical Trials 52

pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Third-quarter sales of Leqvio were just $5 million, although that will reflect the lag between regulatory approval and reimbursement negotiations in European markets.

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Drugs Sales Antibody FDA Approval 104

pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.

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Drugs FDA Approval Insulin Clinical Trials 52

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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Gene Silencing Sales Gene Editing Clinical Trials 98

pharmaphorum

OCTOBER 27, 2022

The antibody – which targets granulocyte-macrophage colony-stimulating factor (GM-CSF) – did show efficacy in the ContRast-1 and ContRast-2 studies, working better than placebo at reducing symptoms of RA in patients who did not respond to conventional disease-modifying antirheumatic drugs (DMARDs), like methotrexate.

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Sales Antibody FDA Approval Trials 97

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

pharmaphorum

OCTOBER 16, 2020

Roche’s pharmaceutical revenues have been hit by falling sales in its pharma division in Q3 but a spike in demand for COVID-19 tests spared the Swiss company’s blushes. Sales of its “big three” cancer drugs were all down considerably in Q3 as cheaper biosimilars gained market share in the US. billion Swiss francs ($1.3

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Sales FDA Approval Marketing Medicine 52

pharmaphorum

NOVEMBER 21, 2022

The US FDA approved the anti-CD3 antibody to delay the onset of stage 3 T1D in patients aged eight years and older who are currently diagnosed with stage 2 disease – a population estimated by Provention to be around 30,000 in the US.

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Drugs Insulin FDA Approval Sales 113

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 104

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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