XTalks

APRIL 3, 2024

Approximately ten to 20 percent of patients with PNH may develop extravascular hemolysis (EVH), a condition that causes RBC destruction outside of blood vessels. Voydeya is the first-in-class, oral, factor D inhibitor developed specifically as an add-on to ravulizumab or eculizumab for patients who develop EVH.

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FDA Approval Sales Trials Development 102

XTalks

NOVEMBER 27, 2024

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.

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FDA Approval Drugs Gene Trials 99

Pharmaceutical Technology

AUGUST 16, 2022

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Q32 will also receive tiered royalty payments on net sales.

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XTalks

JANUARY 29, 2025

Related: Eli Lillys Kisunla (donanemab) Gets Full FDA Approval 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.

FDA Approval 66

FDA Approval Sales Antibody Protein 66

Pharmaceutical Technology

JULY 12, 2022

The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration's (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands. The total market for cell therapies in oncology is projected to exceed $37bn worldwide by 2028.

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Clinical Development Development Production Sales 130

XTalks

JUNE 3, 2024

Biocon Biologics’ Yesafili (aflibercept-jbvf) and Biogen and Samsung Bioepis’ jointly developed Opuviz (aflibercept-yszy) have been given the green light by the US Food and Drug Administration (FDA) as the first interchangeable biosimilars to blockbuster eye drug Eylea. In 2022, global Eylea sales hit $9.6 billion in 2023.

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FDA Approval Sales Clinical Trials Clinical Trials 98

pharmaphorum

NOVEMBER 24, 2020

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. With this third indication, Xofluza has become the first single-dose medicine approved for this new use also known as post-exposure prophylaxis.

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FDA Approval Medicine Licensing Licensing 105

XTalks

JULY 14, 2022

Uncontrolled gout is defined as gout that is unmanageable and/or develops resistance to conventional therapies. Over time, even the use of Krystexxa can lead to the development of antibodies against it, reducing its effectiveness. 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

Camargo

APRIL 7, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. To be successful, such trials require out-of-the-box thinking and experience with the FDA. Fotivda was initially developed for first-line RCC.

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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 Drugs 98

XTalks

OCTOBER 4, 2022

Rolvedon is indicated to lower the chance of infection from febrile neutropenia (the development of fever, often with other signs of infection, in patients with a very low number of neutrophil granulocytes in the blood) in adult patients with non-myeloid malignancies on myelosuppressive anti-cancer drugs. How Does Rolvedon Work?

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

World of DTC Marketing

FEBRUARY 2, 2022

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. Now Biogen wants to partner with Roche to develop a cancer drug?

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FDA Approval Drugs Doctors Doctor 239

Pharmaceutical Technology

MARCH 14, 2023

The agreement is intended for providing commercial support for CTx-1301, after receiving the US Food and Drug Administration (FDA) approval. The new investigational treatment CTx-1301 is being developed as a once-daily stimulant medication for the treatment of ADHD.

FDA Approval 147

FDA Approval Life Science Sales Marketing 147

Camargo

DECEMBER 9, 2020

If you are facing an FDA remote review, Camargo can help design a comprehensive approach in order to avoid such pitfalls. Approval of the Month: Alnylam to Use Value-Based Agreements for Ultra-rare Disease Treatment. Camargo can help you to develop the right pricing and access strategy for your product; contact us for more information.

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Development Production Drugs FDA Approval 140

pharmaphorum

DECEMBER 4, 2020

EGFR mutations are some of the most common mutations in NSCLC, and that has driven sales of Tagrisso – the standard of care for previously-untreated EGFR-positive NSCLC – to more than $3 billion last year. The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.

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FDA Approval Sales Antibody Drugs 93

Pharmaceutical Technology

MAY 19, 2023

Rituxan received its first FDA approval in 1997 for the treatment of B-cell non-Hodgkin’s lymphoma (B-NHL) and reached peak global sales of $7.5bn in 2014. Rituxan’s success made it a prime target for biosimilar developers. Previous analyses by GlobalData suggest that oncology accounts for 85% of Rituxan sales.

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Sales Production Marketing FDA Approval 147

XTalks

DECEMBER 10, 2021

Zavegepant has an advantage over the two as it’s the only CGRP receptor antagonist in both intranasal spray and oral pill formulations that is in clinical development for the treatment of acute or episodic migraines. 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

World of DTC Marketing

JANUARY 10, 2022

billion, which was much lower than previous studies, which have placed the average cost of drug development as $2.8 This study included 63 of 355 new therapeutic drugs and biologic agents approved by the US Food and Drug Administration between 2009 and 2018. million (95% CI, $683.6 million $1228.9

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Pharmaceutical Technology

APRIL 17, 2023

US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA).

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Drugs Drug Delivery FDA Approval Licensing 147

Pharmaceutical Technology

JUNE 6, 2023

Lotus Pharmaceuticals, NRx Pharmaceuticals and Alvogen have entered a global collaboration deal to develop and commercialise NRX-101 for suicidal treatment-resistant bipolar depression (S-TRBD). The company will receive a further $5m on gaining US FDA approval for NRX-101, and $330m milestone payments on reaching net sales targets.

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Sales FDA Approval Production Clinical Trials 130

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. BTK plays an important role in the immune system by regulating B cell receptor signaling through its effects on the development and maturation of B cells.

FDA Approval 97

FDA Approval Life Science Clinical Trials Clinical Trials 97

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

Pharmaceutical Technology

MARCH 31, 2023

GSK has signed an exclusive licence agreement with Scynexis to commercialise and further develop Brexafemme (ibrexafungerp tablets) to treat fungal infection. in specific development, regulatory and commercial milestones related to IC indications. Brexafemme has a wide spectrum of activity, including against emerging resistant threats.

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Sales FDA Approval Clinical Trials Clinical Trials 130

XTalks

NOVEMBER 1, 2024

In this blog, we highlight the top 20 best-selling neurology drugs to watch in 2024, based on 2023 sales statistics. We discuss each drug’s approved uses, sales performance and why they’ve become essential in the neurology space. Related: Top 30 Drugs to Watch in 2024: Insights from 2023 Sales Data 1.

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FDA Approval Drugs Botox Sales 85

XTalks

AUGUST 22, 2022

“With symptom improvement happening at week one and then remission happening by week two, the combination of those two is incredibly differentiating in the marketplace right now,” Lori Englebert, Axsome’s EVP, commercial and business development, said. “If The med brought in $58 million in sales last year for Jazz.

FDA Approval 98

FDA Approval Production Marketing Drugs 98

Pharmaceutical Technology

APRIL 12, 2023

Under its terms, Pharming has paid a $10m milestone payment to Novartis for the first commercial sale of Joenja. In March 2023, Joenja secured approval from the US Food and Drug Administration (FDA) to treat the targeted patients. Both genes are important for the body’s development and for the functioning of immune cells.

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Gene FDA Approval Sales Development 147

Pharmaceutical Technology

JULY 1, 2022

The funding will offer capital to extend Blueprint’s varied pipeline toward marketing as well as to continue seeking strategic and synergistic business development prospects. Ayvakit has received the US Food and Drug Administration (FDA) approval to treat advanced systemic mastocytosis in adults.

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Medicine Business Development Sales Life Science 147

World of DTC Marketing

JANUARY 24, 2022

Venture capitalists have poured $42 billion into drug development over the past three years. Most small biotech companies rely on venture capitalist funding to develop new drugs but is that a good way to go? billion, which was much lower than previous studies, which have placed the average cost of drug development as $2.8

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Life Science Drugs Development Genetic Disease 225

XTalks

FEBRUARY 26, 2024

Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. In 2018, the FDA granted breakthrough designation for Xolair as a treatment for food allergies. billion in sales last year. Xolair earned $3.9

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Allergies FDA Approval Drugs Protein 100

Pharmaceutical Technology

OCTOBER 28, 2022

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 FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending.

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Vaccination Vaccine Marketing Bacteria 162

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. AstraZeneca and Daiichi Sankyo equally share development and commercialisation expenses, as well as profits.

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Sales Trials FDA Approval Development 147

Pharmaceutical Technology

SEPTEMBER 2, 2022

Since the frontline treatment setting is dominated by these regimens, pharma companies have focused on the development of new drugs in the relapsed/refractory (R/R) setting. 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.

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Antibody Sales FDA Approval Production 147

pharmaphorum

JANUARY 24, 2023

Mounjaro (tirzepatide) – the first dual GLP-1/GIP agonist to reach the market – is a big part of that anticipated increase, particularly if Lilly fulfils its objective of getting FDA approval for the drug in obesity as well as type 2 diabetes. The post Lilly injects $450m into plant making Mounjaro appeared first on.

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Sales FDA Approval Packaging Packaging 97

XTalks

DECEMBER 18, 2024

While manageable, the condition requires lifelong treatment and monitoring to prevent complications and ensure healthy development. Ingrezza (valbenazine), first approved in 2017 for tardive dyskinesia, received a key label expansion in 2023 to include the treatment of chorea in patients with Huntingtons disease.

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Genetics Hormones Trials Drugs 116

Pharmaceutical Technology

DECEMBER 5, 2022

Incyte has signed a partnership and licence agreement with CMS subsidiary CMS Aesthetics to develop and market ruxolitinib cream to treat autoimmune and inflammatory dermatologic ailments in Greater China and some Southeast Asian countries. Incyte will also receive royalty payments on the net product sales in the territory of CMS.

Dermatology 130

Dermatology FDA Approval Production Sales 130

pharmaphorum

MAY 31, 2022

The FDA has approved the new use based on the results of the open-label RAINBOWFISH study, which investigated the effects of Evrysdi in children from birth to six weeks who had yet to develop any symptoms of the muscle wasting disorder, said Roche. Analysts think that eventually sales of the drug could reach $2 billion.

FDA Approval 59

FDA Approval Gene Therapy Sales Gene 59

pharmaphorum

MAY 5, 2022

Three years after it was formed as a spinout of Japanese drugmaker Takeda, Phathom Pharmaceuticals has racked up its first FDA approvals, and claimed a sizeable $260 million in new financing to help with the rollout. The post Takeda spinout Phathom claims its first FDA approvals appeared first on.

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FDA Approval Sales Production Trials 52