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Organon Acquires Commercialized Biosimilar to ACTEMRA from Biogen
04 Apr 2025 21:14 GMT
… TOFIDENCE™, a biosimilar to ACTEMRA®, for intravenous infusion from … certain patients for the treatment of moderately to severely … The market, focusing on drug classes such as monoclonal … demand for cost-effective treatments amid rising chronic disease …
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FDA Job Cuts, Key Departures Bring 'Revolving Door' Debate Front and Center
02 Apr 2025 15:40 GMT
… joining the board of biotech Prothena Biosciences in May 2023 … an FDA employee will make decisions in favor of the pharmaceutical … 16 ex-FDA medical examiners who worked on 28 drug approvals were … the FDA’s approval of Genentech’s arthritis drug Actemra and …
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Organon acquires Actemra biosimilar’s US rights from Biogen
02 Apr 2025 16:39 GMT
… intravenous infusion of the Actemra biosimilar, Tofidence, from … with multi-indication arthritis treatment.
Launched in May 2024 … of US Food and Drug Administration (FDA) approval for Tofidence … ’s portfolio includes medicines and products in therapeutic …
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Organon Acquires TOFIDENCE™ (tocilizumab-bavi), a Commercialized Biosimilar to ACTEMRA® (tocilizumab) Injection, for Intravenous Infusion in the U.S.
01 Apr 2025 11:49 GMT
… ACTEMRA. TOFIDENCE is indicated for the treatment … Drugs (DMARDs).
Giant Cell Arteritis (GCA)
TOFIDENCE is indicated for the treatment … .
VACCINATIONS
Avoid use of live vaccines concurrently … to Medicare, Medicaid and health care reform, pharmaceutical …
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Global Actemra Tocilizumab Market: Key Trends, Market Share, Growth Drivers, And Forecast For 2025-2034
18 Mar 2025 12:44 GMT
… Increasing demand for personalized medicine.
o Development and … influences.
Actemra Tocilizumab is widely used in RA treatment to … Research Company:
Narcotic Drugs Global Market Report … ;otic-drugs-global-market-report
Preeclampsia Drugs Global Market …
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Top Ten FDA-Approved Biosimilars Ranked by Therapeutic Importance and Value
14 Mar 2025 01:26 GMT
… colitis
Alvotech & Teva Pharmaceuticals
Janssen Biotech
5
Jubbonti (denosumab-bbdz) … s Nuvaila
Janssen Biotech
7
Tofidence (tocilizumab-bavi)
Actemra (tocilizumab)
Rheumatoid …
10
Avtozma (tocilizumab-anoh)
Actemra (tocilizumab)
Rheumatoid arthritis and …
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Celltrion Launches Autoimmune Disease Treatment in U.S.
13 Mar 2025 03:37 GMT
… Stelara, an autoimmune disease treatment. (Image courtesy of Yonhap … , an autoimmune disease treatment, in the United States … Food and Drug Administration (FDA) approved the biosimilar drug in both … Actemra, as well as Stoboclo and Osenvelt, biosimilar drugs …
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Celltrion FDA Approval Boosts US Asthma Biosimilar Market Entry
10 Mar 2025 20:04 GMT
… market.
The US Food and Drug Administration (FDA) approved Celltrion's … Omlyclo, a biosimilar drug to Xolair, for the treatment of moderate to … sales potential, noting its original drug, Actemra, raised 2.63 billion Swiss …
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July - September 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
05 Mar 2025 21:57 GMT
Actemra (tocilizumab)
Hepatitis B reactivation
FDA determined that … based on available information.
FDA Drug Safety Communication (9… include the risk of medication errors due to … Testosterone Pellets (compounded drug)
Breast Cancer
FDA decided that no …
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October - December 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
05 Mar 2025 21:57 GMT
Actemra (tocilizumab)
Drug reaction with eosinophilia and systemic symptoms
FDA is evaluating … hydrochloride)
Nephrogenic diabetes insipidus
FDA is evaluating the need for … (anakinra)
Drug reaction with eosinophilia and systemic symptoms
FDA is evaluating …