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Commercialization of Ustekinumab and Golimumab Biosimilars
04 Apr 2025 21:45 GMT
… for proposed ustekinumab and golimumab biosimilars in Southeast Asia … and BAT2506 (the proposed golimumab biosimilar referencing Janssen’s … ustekinumab-kfce). YESTINTEK received FDA approval in December 2024 … are indicated for the treatment of patients 6 years …
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FDA Warning ‘Bombshell’ Caps Top JIA Developments for 2024
20 Mar 2025 12:06 GMT
… were deemed drug tolerant during biologic treatment and … Medical Center, included the 14 participants of the phase 2 EMERALD trial … drugs approved for JIA during 2020-2023 (tofacitinib, golimumab … blown RCTs [randomized controlled trials], you can [collect …
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Global Simponi And Simponi Aria Golimumab Market Insights 2025: Key Trends, Market Size, And Growth Forecast
19 Mar 2025 15:46 GMT
… treatments for arthritis and colitis.
o Ongoing clinical trials … disease treatment.
o Growth in subcutaneous drug delivery … Simponi Aria Golimumab provide targeted biological treatment for autoimmune … , a Germany-based pharmaceutical firm, announced an …
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Top biotech deals of February 2025
06 Mar 2025 21:42 GMT
… focused on creating treatments for immune-mediated … Drug Administration (FDA). It will be renamed PHT-776 as American biotech … of the monoclonal antibody golimumab, in the U … another Massachusetts-based biotech Corbus Pharmaceuticals.
The biotech has snagged …
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Bio-Thera signs US deal with Intas for golimumab biosimilar
11 Feb 2025 10:41 GMT
… commercialisation agreement with Intas Pharmaceuticals for the Simponi (golimumab) biosimilar, BAT2506 in … G 1 (IgG1) monoclonal antibody golimumab is used to target a … a decrease in inflammatory markers.
Golimumab is approved for treating ulcerative …
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Accord BioPharma Strengthens Pipeline Through Exclusive U.S. Licensing Agreement with Bio-Thera for BAT2506, a Proposed Golimumab Biosimilar
10 Feb 2025 13:44 GMT
… of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), … to Simponi® (golimumab). Binding of golimumab to TNF- … treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical … candidates in clinical trials, focusing on …
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FDA Accepts BLA for Golimumab Biosimilar for Inflammatory Conditions
06 Feb 2025 01:39 GMT
… Biosimilars are ushering a new treatment paradigm and have become … and a wider range of treatment options," Thomas Nusbickel … accessible and high-quality treatment options for patients and … and-Simponi-Aria-golimumab.html
U.S. FDA approves Celltrion…
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Alvotech and Teva Announce First FDA Acceptance of aBLA for Simponi® / Simponi Aria® (golimumab) Biosimilar
05 Feb 2025 18:48 GMT
… , Alvotech and Teva announced the FDA acceptance of an aBLA for … ’s Simponi® / Simponi Aria® (golimumab). This is the first publicly … of a golimumab biosimilar. According to a press release, the FDA review …
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FDA Reviews Golimumab Biosimilar, Samsung Biologics Hits Record Sales, Japan Approves Stelara Biosimilar
30 Jan 2025 16:03 GMT
… s and Teva Pharmaceuticals’ proposed biosimilar to golimumab (Simponi and … history as the first biotech company in the … Approves Stelara Biosimilar
The Pharmaceuticals and Medical Devices Agency (PMDA) … , Yoshindo Inc. The drug was designed and approved …
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Psoriatic Arthritis Pipeline Therapeutics Assessment, FDA Approvals, Drugs And Companies | Delveinsight
29 Jan 2025 04:36 GMT
… 2025:- Janssen Pharmaceuticals:- The purpose … of guselkumab plus golimumab combination treatment in participants … Psoriatic Arthritis clinical trials, emerging drugs, and market opportunities … drug is in Phase II stage of its clinical trial for the treatment …