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It includes Roches Alecensa (alectinib), Takedas Alunbrig (brigatinib) and Pfizers third-generation Lorbrena (lorlatinib), which have all surpassed Xalkori in performance, leading to their respective FDAapprovals for first-line treatment. Roches Alecensa is the current ALK inhibitor market leader. billion Swiss francs ($1.28
The heart and vascular medication market continues to be a critical focus area for pharma companies, with billions of dollars in sales generated annually. In this blog, we take a closer look at the top 10 heart and vascular medications based on recent sales data. Eliquis (Apixaban) Eliquis 2023 sales :$12.21
Clinical Trials Backing Qfitlias Approval Two Phase III studies involving adult and pediatric male patients with hemophilia A or B supported Qfitlias FDAapproval. Qfitlia is the second RNA interference therapy to receive a highly anticipated FDAapproval recently. In 2024, it registered sales of $4.9
Maraoui said the company’s dermatology-focused sales force is “now preparing for a successful launch and to establish Emrosi as a new standard of care in the treatment of rosacea.” Emrosi consists of minocycline, a tetracycline antibiotic, to target bacterial infection that can underlie rosacea.
The FDA has approved Novo Nordisks Ozempic (semaglutide) for reducing the risk of kidney failure, progression of kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). The approval marks Ozempic as the first GLP-1 receptor agonist (GLP-1 RA) authorized in a kidney disease indication.
The top 20 companies in the global biopharma industry saw 5.4%* aggregate market capitalization from $3.43 Pfizer maintained its third-place position in the market in 2022, reporting a market capitalization of $287.6 witnessed the biggest market capitalization growth of 45.3% trillion to $3.61 billion on Dec 31, 2022.
The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Data from two Phase III studies, U-EXCEED and U-EXCEL, involving 857 patients was used to support the approval.
Novo Nordisk’s leading drug Ozempic (semaglutide) is forecast to demonstrate a sales growth of 23% in 2023. Ozempic’s forecast 2023 sales of $12.5bn consolidate its position as the dominant market leader, with projected sales in 2023 54% greater than closest competitor Trulicity (dulaglutide) by Eli Lilly, which anticipates sales of $8bn.
Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDAapproval for a cancer therapeutic based on T cell receptor (TCR) technology. The post Immunocore claims first-ever FDAapproval for TCR cancer therapy appeared first on.
It is already the first proposed high-concentration (100mg/mL), low-volume and citrate-free adalimumab biosimilar in the world to receive marketing authorisation from the European Commission. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDAapproval.
While the government said that Gilead secured its PrEP approvals only after CDC’s research on the topic, the company stated that there already were published materials on the potential use of antiretroviral therapies as PrEP prior to this. Gilead markets both Truvada and its successor Descovy.
The US Food and Drug Administration (FDA) has granted final approval to India-based Zydus Lifesciences ‘ 500mg azithromycin tablets for the treatment of bacterial infections. Zydus, which currently has 360 approvals, has filed abbreviated new drug applications for more than 440 drugs since 2003-04.
On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. In June 2021, the FDAapproved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending.
The global market for eye drugs continues to grow as vision-related conditions, particularly among aging populations, drive demand for innovative therapies. In this blog, we delve into the recent sales data to highlight the top three best-selling eye drugs in 2023. Fourth-quarter US net sales of Eylea in 2023 totaled $1.34
Back in 2014, AstraZeneca and Merck were the first to receive FDAapproval for their PARP inhibitor Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients.
The approval comes after the FDA made several requests for additional data, which lengthened the approval process that began in 2021. Surmodics will manufacture and supply the device and realize revenue from product sales to Abbott as well as a share of profits from Abbott’s third-party sales.
Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDAapproval for first-in-class lung cancer therapy Exkivity. The post Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDAapproval appeared first on.
While Soliris had its market launch 17 years ago with $3.2 billion in sales in 2023, Ultomiris was approved in 2018 and generated $3 billion in revenue last year. Voydeya’s FDAapproval was based on positive results from the pivotal ALPHA Phase III trial.
More than half of the top 20 global biopharmaceutical companies saw a fall in market capitalisation over Q1 2023. decline in total aggregate market capitalisation from $3.61 Bayer reported the highest market capitalisation growth of 23.1% Sanofi and Regeneron’s market capitalisation grew by 12.4% This resulted in a 3.4%
SUMMARY: Doctors said they were dissatisfied were marketing emails (46%), telephone sales calls with sales reps (42%), and both webinars and websites (each at 39%) from pharma companies, according to Indegene. It can’t be promotional or sales information and should not be a long document. 100 percent of U.S.
Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. billion in sales in 2020 and has been outselling Merck’s previous shot, Pneumovax 23, by almost five to one.
First approved in 2011, Eylea’s market value was estimated to be $8.79 As one of Regeneron’s best-selling drugs, US sales of Eylea were approximately $5.89 First approved in 2022 and winning a subsequent approval in 2023 for macular edema following RVO, Vabysmo exceeded sales expectations earning about $2.7
The top 20 global biopharmaceutical companies exhibited a downward trend in aggregate market capitalisation by 9.1% This downturn in market cap was attributed to a decline in the demand for Covid-19 vaccines and therapies. Bayer recorded a negative market capitalization growth of 22.3% trillion in Q2 2022 to $3.14
While Merck says the vaccine is specifically designed for adults and covers serotypes that cause about 84 percent of IPD in adults 50 years of age and older, it is officially approved for adults 18 years of age and older. Pfizer’s Prevnar 20 was first approved in 2021 for adults 18 years of age and older and has since dominated the market.
Syndax Pharmaceuticals’ Revuforj (revumenib) has won US Food and Drug Administration (FDA) approval for the treatment of relapsed or refractory (R/R) acute leukemia in patients aged one year and older who have a lysine methyltransferase 2A ( KMT2A, formerly MLL ) gene translocation. percent of US sales revenue from Niktimvo.
The agreement is intended for providing commercial support for CTx-1301, after receiving the US Food and Drug Administration (FDA) approval. Additionally, it intends to start a fixed-dose, placebo-controlled, pivotal Phase III trial in ADHD paediatric and adolescent patients in the middle of this year.
Related: Eli Lillys Kisunla (donanemab) Gets Full FDAApproval After Initial Rejection, Gears Up to Take on Leqembi Leqembi was first approved in 2023 as a monoclonal antibody targeting amyloid-beta protofibrils and plaques proteins that cause brain cell damage and cognitive decline in Alzheimers disease.
Rituxan received its first FDAapproval in 1997 for the treatment of B-cell non-Hodgkin’s lymphoma (B-NHL) and reached peak global sales of $7.5bn in 2014. Globally, the first rituximab biosimilar, Dr Reddy’s Laboratories’ Reditux, was approved in India in 2007.
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 FDAapproval, this time for BMS’ Istodax appeared first on.
Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list.
Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. However, it is possible to target CD33 in the clinic, as evidenced by the FDAapproval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000.
The biotherapeutics market is rapidly growing, with 2021 seeing the highest-ever cell and gene therapy approval number. The first FDA-approved gene therapies (Luxturna and Kymriah) entered the market in 2017. The future of cell and gene therapies. Collaboration and integrated manufacturing.
market until next year, with the pharmaceutical company announcing Tuesday a settlement with the Iceland-based Alvotech. Sales of Humira earned AbbVie $20.7 AbbVie won dozens of additional patents — what critics call a “patent thicket” — that extended the exclusive market for the drug. Richard Gonzalez, C.E.O.
Rolvedon’s approval marks Spectrum’s transformation to a commercial-stage company with the opportunity to compete in a $2 billion dollar market, and offers a unique value proposition,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals, in the company’s press release. How Does Rolvedon Work?
Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. The drug generated domestic sales of $200.4 million last year, of which $131.3
Related: AstraZeneca’s Enhertu Gets FDAApproved as First Therapy for HER2-Low Breast Cancer. Imjudo’s approval was based on results from the HIMALAYA Phase III trial , which showed that patients treated with the Imjudo and Imfinzi combination experienced a 22 percent reduction in the risk of death versus sorafenib.
The FDA has approved a new use for Xofluza (baloxavir marboxil) from Roche’s Genentech unit, to prevent people developing flu after coming into contact with an infectious person. Xofluza has already been on the market for two years, and already had licensed uses to treat uncomplicated flu and those at high risk of complications.
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 FDAapproval appeared first on.
Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Putting it on the market will stress Medicare’s resources.”
The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM. The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM. The therapy received FDAapproval in October last year.
Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.
Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 That money is gone without any clinical benefit and the executives at those drug companies received compensation because of those sales. This is another example of just how screwed up our healthcare system really is.
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