Psoriatic arthritis

MoonLake Immunotherapeutics Reports Full Year 2023 Financial Results, Recent Business Highlights and Announces an R&D Day on March 10

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목요일, 2월 29, 2024

Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “2023 was another momentous year for MoonLake in the inflammation and immunology field.

Key Points: 
  • Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “2023 was another momentous year for MoonLake in the inflammation and immunology field.
  • On top of this, support from world-renowned experts, clinicians, and patient organizations for our data, science and methodologies continues to mount.
  • Matthias Bodenstedt, Chief Financial Officer at MoonLake Immunotherapeutics, said: “MoonLake has added considerable shareholder value over the past year, and we are driven to continue building on this.
  • Other non-operating income increased from $0.6 million in the prior year to $10.1 million for the year ended December 31, 2023.

MoonLake Immunotherapeutics Announces Positive Feedback from both FDA and EMA on Regulatory Path for the Phase 3 Program of the Nanobody® sonelokimab (SLK) in Hidradenitis Suppurativa (HS)

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월요일, 2월 26, 2024

European Medicines Agency (EMA), with both regulatory bodies unanimously supporting MoonLake’s proposed approach for advancing its Phase 3 program of the Nanobody® sonelokimab (SLK) in hidradenitis suppurativa (HS).

Key Points: 
  • European Medicines Agency (EMA), with both regulatory bodies unanimously supporting MoonLake’s proposed approach for advancing its Phase 3 program of the Nanobody® sonelokimab (SLK) in hidradenitis suppurativa (HS).
  • The Phase 3 program, named VELA, is expected to enroll 800 patients and in combination with the data from Phase 2 MIRA trial will support both a Biologics License Application (BLA) and E.U.
  • We deeply appreciate the support from both agencies and continue to work swiftly to ramp up the Phase 3 program in HS, named VELA.
  • Moonlake will provide more information relating to the plans for both the HS and PsA programs during an upcoming R&D Day.

Global Psoriatic Arthritis Drug Landscape Research Report 2024: Comprehensive Insights About 20+ Companies and 25+ Pipeline Drugs - ResearchAndMarkets.com

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수요일, 3월 6, 2024

This report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Psoriatic Arthritis pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Psoriatic Arthritis pipeline landscape.
  • A detailed picture of the Psoriatic Arthritis pipeline landscape is provided which includes the disease overview and Psoriatic Arthritis treatment guidelines.
  • The assessment part of the report embraces, in depth Psoriatic Arthritis commercial assessment and clinical assessment of the pipeline products under development.
  • Psoriatic Arthritis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

United States HUMIRA Market Analysis, Size, Forecast, and Insights Report, 2019-2023 and 2024-2032 - ResearchAndMarkets.com

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금요일, 3월 1, 2024

The "US HUMIRA Market Size, Forecast, and Market Insight - 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "US HUMIRA Market Size, Forecast, and Market Insight - 2032" report has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about HUMIRA for autoimmune uveitis in the US.
  • Further, it also consists of future market assessments inclusive of the HUMIRA market forecast analysis for autoimmune uveitis in the US, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in autoimmune uveitis.
  • What are the other emerging products available and how are these giving competition to HUMIRA for autoimmune uveitis?

Biocon Biologics Secures US Market Entry Date for Bmab 1200, a Proposed Biosimilar to Stelara®

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목요일, 2월 29, 2024

The agreement licenses the Company to launch in the United States, in February 2025, once approved by the U.S. FDA.

Key Points: 
  • The agreement licenses the Company to launch in the United States, in February 2025, once approved by the U.S. FDA.
  • The U.S. FDA has accepted the Company's Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway.
  • Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: "This settlement agreement reflects our commitment and focus on science and innovation.
  • As a fully integrated biosimilars company, Biocon Biologics is committed to expanding access to life-changing treatments with our broad portfolio of products."

Autoimmune Disease and Pregnancy: ISB Study Challenges Prevailing Wisdom, Unveils Nuances

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수요일, 1월 31, 2024

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240131144327/en/
    In a just-published study in the journal Lancet eClinical Health , researchers at the Institute for Systems Biology (ISB) and Providence showed nuanced pregnancy outcomes for pregnant individuals with autoimmune disease.
  • Each type of autoimmune disease is different, each person has their own medical history, and risk may change over the course of pregnancy.
  • This study highlights the importance of taking comorbidities into consideration,” said ISB Associate Professor Jennifer Hadlock, MD , who led the study.
  • “These results can help reshape discussions surrounding autoimmune disease and pregnancy, and bring fresh perspective to a traditionally understudied area in research,” Hadlock said.

OrphAI Therapeutics Announces Appointment of Jay Fine to Board of Directors

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수요일, 1월 24, 2024

GUILFORD, Conn., Jan. 24, 2024 (GLOBE NEWSWIRE) -- OrphAI Therapeutics Inc. (“OrphAI”) , a clinical-stage biopharmaceutical company developing novel therapeutics for rare diseases, announced today the appointment of Jay S. Fine, Ph.D. to its Board of Directors.

Key Points: 
  • GUILFORD, Conn., Jan. 24, 2024 (GLOBE NEWSWIRE) -- OrphAI Therapeutics Inc. (“OrphAI”) , a clinical-stage biopharmaceutical company developing novel therapeutics for rare diseases, announced today the appointment of Jay S. Fine, Ph.D. to its Board of Directors.
  • Dr. Fine has a strong track record of drug discovery and development leadership in respiratory diseases, oncology, immunology and fibrotic disease indications.
  • “I am very pleased to join the OrphAI Therapeutics’ Board of Directors,” said Dr. Fine.
  • I look forward to working closely with the OrphAI team and its board to accelerate the progress of its promising pipeline.”
    “We are excited to welcome Jay Fine to our Board of Directors,” said David Scheer, Chairman of the Board of Directors at OrphAI.

Changes Afoot for the Treatment of Psoriatic Arthritis with Marked Gains in Preference and Utilization of IL-17 Inhibitors

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월요일, 1월 22, 2024

However, recent years have witnessed a transformative shift in both the US and EU markets, as rheumatologists increasingly favor alternative mechanisms, notably IL-17 inhibitors.

Key Points: 
  • However, recent years have witnessed a transformative shift in both the US and EU markets, as rheumatologists increasingly favor alternative mechanisms, notably IL-17 inhibitors.
  • In contrast, within that timeframe, rheumatologists saw a preference for IL-17s more than double, indicating a noteworthy transformation in treatment preferences.
  • Over half of rheumatologists cite efficacy as their primary motive for favoring IL-17 inhibitors in PsA treatment, regularly underscoring the class’s success in treating both skin and joint manifestations.
  • As the treatment landscape for PsA undergoes dynamic changes, staying ahead of these shifting trends becomes essential for effective patient management and optimal treatment outcomes.

New Study Finds People With Inflammatory Arthritis Are More Likely To Seek Mental Health Care

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수요일, 1월 24, 2024

A recent study conducted by a team of scientists at Arthritis Research Canada has found a link between IA and the need for mental health treatment and medication.

Key Points: 
  • A recent study conducted by a team of scientists at Arthritis Research Canada has found a link between IA and the need for mental health treatment and medication.
  • This research aimed to describe patterns of depression and anxiety health care before and after a diagnosis among people with IA, including: ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis.
  • "The results of this study are revealing, but this is only a starting point," said Dr. Alyssa Howren, Research Trainee at Arthritis Research Canada.
  • "We need additional research to investigate alternative explanations as to why people with inflammatory arthritis have a higher requirement for mental health care and medication."

STADA and Alvotech secure approval for Uzpruvo, Europe’s first ustekinumab biosimilar to Stelara

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수요일, 1월 10, 2024

Biosimilar competition in the €2.5 billion (US$2.7 billion) EU ustekinumab market could significantly expand patient access to this life-changing biologic therapy within gastroenterology, dermatology, and rheumatology.

Key Points: 
  • Biosimilar competition in the €2.5 billion (US$2.7 billion) EU ustekinumab market could significantly expand patient access to this life-changing biologic therapy within gastroenterology, dermatology, and rheumatology.
  • STADA’s Global Specialty Head, Bryan Kim, commented: “This first marketing authorization for biosimilar ustekinumab in Europe offers the potential to expand substantially patient access through competition.
  • Under a strategic partnership begun in 2019, Alvotech is primarily responsible for developing and manufacturing the AVT04 ustekinumab biosimilar.
  • These include a high-concentration, citrate-free adalimumab biosimilar developed and marketed through the partnership between Alvotech and STADA.