Infliximab | Jotup

Breakthroughs in Kexing Biopharm's Overseas Efforts: Qualification of Two Licensed Products for GMP Audits in Egypt

Retrieved on:

Mardi, avril 2, 2024

Ulcerative colitis, Psoriasis, Rheumatoid arthritis, Growth, Ankylosing spondylitis, Drug, EDA, Ageing, Kingdom Holding Company, Crohn's disease, Lung cancer, GMP, Bevacizumab, Infliximab, Pharmaceutical industry

In 2022, Kexing Biopharm secured agreements with 24 overseas market customers and commenced the submission of local drug access registration documents.

Key Points:

In 2022, Kexing Biopharm secured agreements with 24 overseas market customers and commenced the submission of local drug access registration documents.
The product underwent GMP audits in Egypt, Brazil, and Indonesia respectively in September 2023, February 2024, and March 2024.
In 2022, Kexing Biopharm swiftly reached agreements with 23 overseas market customers, initiating the submission of drug access registration documents.
By establishing local subsidiaries, Kexing Biopharm strives to accelerate product registration processes and enhance competitiveness in overseas markets.

Completion of PIC/S Participating Authorities' Audits of Kexing Biopharm's Licensed Product Infliximab for Injection

Retrieved on:

Mardi, avril 2, 2024

Certification, Brazilian Health Regulatory Agency, News, EPO, ANVISA, GMP, PIC/S, Infliximab, Food

New York, New York--(Newsfile Corp. - April 2, 2024) - The product infliximab for injection, licensed by Kexing Biopharm, has recently experienced a wave of encouraging news regarding its international commercialization.

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New York, New York--(Newsfile Corp. - April 2, 2024) - The product infliximab for injection, licensed by Kexing Biopharm, has recently experienced a wave of encouraging news regarding its international commercialization.
In addition, this month, the product has undergone a site GMP audit by another PIC/S Participating Authority, the Indonesian Food and Drug Authority (BPOM).
The company's proprietary product, human erythropoietin (EPO), has been present in Indonesia since 2005, gaining popularity and increasing market share.
In terms of infliximab, progress has been remarkable in the overseas factory inspection since the third quarter of 2023.

Gastroenterologists Slow to Adopt Eli Lilly’s Omvoh, Pfizer’s Velsipity, and Takeda’s subcutaneous formulation of Entyvio for the Treatment of Ulcerative Colitis, but Future Projections Reveal a Highly Evolving Market

Retrieved on:

Vendredi, mars 22, 2024

Launch, Ulcerative colitis, Benchmarking, Patient, Gastroenterology, RealTime, Inflammatory bowel disease, FDA, Infliximab, Pharmaceutical industry

The latest results reveal gastroenterologists (n=73) have been slow to incorporate the newest entrants into their already bustling armamentarium, though project rapid adoption over the course of 2024.

Key Points:

The latest results reveal gastroenterologists (n=73) have been slow to incorporate the newest entrants into their already bustling armamentarium, though project rapid adoption over the course of 2024.
In terms of unaided awareness of the newly approved medications, Omvoh had the highest recall rates, followed closely by Velsipity and more distantly by Entyvio SC.
Conversely, but as expected, Entyvio SC is the most familiar among the three, followed by Velsipity and then Omvoh.
The adoption trends regarding gastroenterologist trial rates, overall market share, and average patient initiations exhibit a consistent pattern.

Advanced Infliximab Model Now Available from DoseMe

Retrieved on:

Vendredi, mars 15, 2024

Technology, Research, Health Technology, Software, Biotechnology, Health, Pharmaceutical, Data Management, Science, Inflammatory bowel disease, Risk, Infliximab, IBD, Patient, Immunoglobulin G, BCPS, Doctor of Pharmacy, Inflammation, Vaccine

DoseMe , a leading provider of model-informed precision dosing, today announced the availability of its Infliximab model.

Key Points:

DoseMe , a leading provider of model-informed precision dosing, today announced the availability of its Infliximab model.
Infliximab (IFX) is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor necrosis factor-alpha(TNFα).
"We continue to enhance our models, and this model may predict infliximab concentration in patients with anti-drug antibodies,” added Roy.
“Both the learning set and validation set of this model had a large diversity in an indication of the patients, thus making this model especially equipped to dose infliximab for many indications.”
For more information and an overview of all models currently available, visit https://doseme-rx.com/why-dosemerx/drug-packages

Citryll Announces the Appointment of Maarten Kraan as Chief Medical Officer

Retrieved on:

Mardi, février 13, 2024

Citryll, a clinical-stage biotech company developing first-in-class therapeutics to treat immune-mediated inflammatory diseases, today announced the appointment of Maarten Kraan, M.D., Ph.D., as Chief Medical Officer.

Key Points:

Citryll, a clinical-stage biotech company developing first-in-class therapeutics to treat immune-mediated inflammatory diseases, today announced the appointment of Maarten Kraan, M.D., Ph.D., as Chief Medical Officer.
Prior to that, he held various senior medical and R&D positions at Pierre Fabre S.A., AstraZeneca, Roche and Bristol Myers-Squibb.
Dr. Kraan will replace Dr. Patrick Round, who will continue to support the company during the transition period.
Notably, Dr. Kraan was also involved in the development of Orencia (abatacept), Remicade (infliximab), Humira (adalimumab) and fostamatinib for rheumatoid arthritis.

Johnson & Johnson Reports Q4 and Full-Year 2023 Results

Retrieved on:

Mardi, janvier 23, 2024

Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Key Points:

Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.
Innovative Medicine worldwide operational sales, excluding the COVID-19 Vaccine, grew 7.2%*.
Notable New Announcements in the Quarter:
The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K.
Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson.

Celltrion presents strategic vision and growth plan at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on:

Jeudi, janvier 11, 2024

Celltrion, Patient, Health, Intelligence, Biosimilar, PHS, Infliximab, Conference, Drug development, FDA, Pharmaceutical industry

Celltrion's Chairman Jung-Jin Seo and CEO Jin-Seok Seo discussed the company's strategic priorities and progress, including the company's vision to move beyond biosimilars through the 2024 launch of ZYMFENTRA™ in the U.S. and expansion into digital healthcare.

Key Points:

Celltrion's Chairman Jung-Jin Seo and CEO Jin-Seok Seo discussed the company's strategic priorities and progress, including the company's vision to move beyond biosimilars through the 2024 launch of ZYMFENTRA™ in the U.S. and expansion into digital healthcare.
He also shared insights and trends on the biosimilar industry and how the market landscape is impacting Celltrion's strategy.
Jin-Seok Seo said, ''Celltrion has the potential to grow its revenue by at least fivefold in 2030, once our 22-drug portfolio is commercialized.
Celltrion remains committed to pursuing its goal in promoting the health and well-being of patients."

US Gastroenterologist Projections Suggest Significant Shift in Ulcerative Colitis Landscape Afoot, with Launches of Eli Lilly's Omvoh, Pfizer's Velsipity, Takeda's Subcutaneous Entyvio, and Celltrion's Zymfentra

Retrieved on:

Lundi, novembre 13, 2023

These additions come amidst an already bustling market, teeming with both branded and increasingly competitive biosimilar alternatives.

Key Points:

These additions come amidst an already bustling market, teeming with both branded and increasingly competitive biosimilar alternatives.
However, the influx of innovative agents suggests that upcoming changes are poised to be more substantial and transformative.
This extension enjoys the highest pre-launch familiarity and generates significantly higher interest in gaining approval.
Although prescribers display significant enthusiasm for Entyvio SC, its anticipated impact on the broader market is projected to be modest.

Inflectra Announces Partnership with Trustify Technology

Retrieved on:

Mercredi, décembre 6, 2023

WASHINGTON, Dec. 6, 2023 /PRNewswire/ -- Inflectra, a global market leader in IT Software Lifecycle Management solutions, announced its partnership with Trustify Technology.

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WASHINGTON, Dec. 6, 2023 /PRNewswire/ -- Inflectra, a global market leader in IT Software Lifecycle Management solutions, announced its partnership with Trustify Technology.
Trustify Technology, headquartered in Ho Chi Min City, Vietnam, services customers around the globe with Agile Software Development, QA Testing, Big Data, Machine Learning, and AI.
Trustify Technology benefits from Inflectra's established market influence and a suite of comprehensive lifecycle management solutions.
CEO and Founder of Inflectra, Adam Sandman, shares: "We are excited to forge a partnership with Trustify Technology, with their deep development experience and market knowledge of Vietnam.

Kexing Biopharm Attended CPHI Worldwide 2023

Retrieved on:

Mardi, novembre 7, 2023

Adalimumab, Autoimmunity, Exhibition, Neoplasm, Patient, Marketing, Infliximab, Fine chemical, Tourism, Trastuzumab, Bevacizumab

SHENZHEN, China, Nov. 7, 2023 /PRNewswire/ -- Recently, CPHI Worldwide 2023 was successfully held in Barcelona, Spain.

Key Points:

SHENZHEN, China, Nov. 7, 2023 /PRNewswire/ -- Recently, CPHI Worldwide 2023 was successfully held in Barcelona, Spain.
Although Kexing Biopharm specially booked a large booth including independent conference rooms for this exhibition, the seats were still packed with customers who came in an endless stream, and the scene was extremely popular.
Many overseas customers expressed great interest in several high-end drugs shown by Kexing Biopharm, and actively explored joint development of overseas business with the company.
The participating team of Kexing Biopharm exchanged experiences and discussed with industry leaders, aiming to explore the future development of the industry.