XTalks

APRIL 24, 2024

ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC). Anktiva made pharma data intelligence firm Evaluate’s list of top ten drug launches this.

FDA Approval 52

FDA Approval Vaccination Vaccine Sales 52

XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. While Eylea’s sales have been on the decline, Vabysmo has been picking up steam.

FDA Approval 104

FDA Approval Clinical Trials Clinical Trials Sales 104

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Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial.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

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.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

Pharmaceutical Technology

SEPTEMBER 2, 2022

Multiple myeloma (MM) therapeutics comprise a multi-billion dollar market, among the most valuable in oncology. lenalidomide) + a steroid ± an anti-CD38 antibody. The first anti-BCMA product to enter the R/R market was GlaxoSmithKline’s antibody-drug conjugate (ADC) Blenrep (belantamab mafodotin-blmf), gaining FDA approval in 2020.

Antibody 147

Antibody Sales FDA Approval Production 147

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. This includes a greater focus on digital campaigns and diversifying marketing campaigns with race and ethnicity insights.

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

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.

FDA Approval 52

FDA Approval Drugs Pharma Companies Clinical Trials 52

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 78

FDA Approval Sales Antibody Marketing 78

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 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.

FDA Approval 52

FDA Approval Drugs Sales Trials 52

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.

Vaccination 59

Vaccination Vaccine Marketing Sales 59

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).

Marketing 85

Marketing Antibody Drugs Sales 85

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.

FDA Approval 98

FDA Approval Gene Therapy Antibody Gene 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.

FDA Approval 60

FDA Approval Antibody Branding Trials 60

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.

Antibody 52

Antibody Sales FDA Approval Genetics 52

XTalks

MAY 29, 2024

The global pharmaceutical market has been expanding at an unprecedented pace. According to Statista , in 2023, the market was estimated to be worth about $1.6 The top ten pharma companies in 2023 by revenue accounted for about 35 percent of the market value, with total earnings of $559.5 billion, an increase of 10.8

Pharma Companies 52

Pharma Companies Sales FDA Approval 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.

FDA Approval 52

FDA Approval Production Clinical Trials Clinical Trials 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.

Drugs 52

Drugs FDA Approval Sales Vaccination 52

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.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

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. Novartis resubmitted its marketing application in the US earlier this year, after swapping fill-and-finish production to one of its own facilities in Schaftenau, Austria.

Drugs 103

Drugs Sales Antibody FDA Approval 103

pharmaphorum

JANUARY 18, 2021

This latest indication adds to Enhertu first approval at the end of 2019 for advanced HER2-positive breast cancer after two or more HER2-targeted regimens. Sales of Enhertu in the US are recognised by Daiichi Sankyo. It also showed a median progression-free survival (PFS) of 5.6 months compared to 3.5 months with chemotherapy.

Sales 111

Sales Antibody FDA Approval Trials 111

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

Sales 52

Sales FDA Approval Marketing Medicine 52

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.

Sales 52

Sales Antibody FDA Approval Drugs 52

XTalks

DECEMBER 19, 2023

In the fast-evolving pharmaceutical landscape, tracking the top-selling drugs offers valuable insights into trends, healthcare priorities and the dynamics of the global market. As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. billion in sales in 2022.

Sales 64

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.

Gene Therapy 98

Gene Therapy Gene FDA Approval Antibody 98

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.

FDA Approval 101

FDA Approval Drugs Sales Development 101

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. It also has an option on global marketing rights to the drug.

Drugs 115

Drugs Insulin FDA Approval Sales 115

Pharmaceutical Technology

OCTOBER 5, 2022

In 2009, Tysabri was performing well, having yielded $776 million in sales after being first approved in 2004, as per Biogen’s 2009 financial filings. However, new MS drugs like Novartis ’ Gilenya, were going to soon enter the market and increase competition within the MS therapeutic landscape.

Sales 147

Sales Compliance Marketing Drugs 147

pharmaphorum

OCTOBER 24, 2021

Roche’s Genentech unit has won FDA approval for Susvimo, an implant for eyesight-robbing disease wet age-related macular degeneration (AMD) that gives patients an alternative to regular injections into the eye. billion in US sales, while Novartis’ sales of the drug topped $1.9

Sales 94

Sales Clinical Trials Clinical Trials Antibody 94

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.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

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.

Sales 87

Sales Antibody FDA Approval Trials 87

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.

FDA Approval 52

FDA Approval Drugs Insulin Clinical Trials 52

pharmaphorum

NOVEMBER 10, 2021

The agreement includes a sizeable $500 million upfront payment, reflecting that Nurtec ODT (rimegepant) is already FDA-approved for treating acute migraine with and without aura in adults, and for prevention of episodic migraine in patients who suffer less than 15 headache days per month.

Licensing 52

Licensing Licensing Drugs Sales 52

pharmaphorum

MARCH 23, 2022

Argenx only recently scored FDA approval for its intravenous anti-neonatal FC receptor (FcRn) antibody Vyvgart for generalised myasthenia gravis (gMG), but is already looking to defend its franchise with a new subcutaneous version of the drug. After 29 days’ treatment IgG levels were reduced by 66.4% in the IV arm.

Antibody 52

Antibody Sales FDA Approval Trials 52

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).

Antibody 52

Antibody Trials Production Clinical Trials 52

pharmaphorum

APRIL 5, 2022

It will also come up against two established antibody-based PCSK9 inhibitors – Amgen’s Repatha (evolocumab) and Sanofi/Regeneron’s Praluent (alirocumab) – which can like AZD2833 are administered once a month. billion in sales by 2027, ahead of Repatha at $2.2 billion with Praluent a distant third at just over $700 million.

Drugs 52

Drugs Antibody Sales FDA Approval 52