Tocilizumab

Sobi Receives US FDA Fast Track Designation for Emapalumab-lzsg being investigated in Macrophage Activation Syndrome

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星期五, 五月 24, 2024
Patient, Infosys, Food, Emapalumab, Hemophagocytic lymphohistiocytosis, FDA, Fever, Condylar resorption, Swedish Orphan Biovitrum, Death, Rheumatology, Tocilizumab, Medicine, Fast Track, Ferritin, Hepatosplenomegaly, Interferon, Cytopenia, Liver, Macrophage activation syndrome, MAS, HLH, Pharmaceutical industry

WALTHAM, Mass., May 24, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to emapalumab-lzsg being investigated as a potential therapeutic option in patients with Macrophage Activation Syndrome (MAS).

Key Points: 
  • WALTHAM, Mass., May 24, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to emapalumab-lzsg being investigated as a potential therapeutic option in patients with Macrophage Activation Syndrome (MAS).
  • Emapalumab is a fully human, anti-IFNγ monoclonal antibody that binds free and receptor-bound IFNγ, neutralizing its biological activity.
  • Fast track designation is designed to facilitate the development and expedite the review of medicines to treat serious conditions that may fill an unmet medical need.
  • MAS is a severe complication of rheumatic diseases, most frequently in Still’s disease including systemic juvenile idiopathic arthritis (sJIA).

InflaRx Presents New Analysis of PANAMO Phase III Trial in Severe COVID-19 at ATS 2024 Showing Potential Synergy With Vilobelimab When Used in Combination with Other Immunomodulators

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星期二, 五月 21, 2024
Patient, COVID-19, IMV, Food, FDA, Mortality, Tocilizumab, Conference, American Thoracic Society, MD, Hospice and palliative medicine, JAK, Risk, ATS, Intensive care medicine, Poster, Safety, Therapy, Standard of care, Pharmaceutical industry

InflaRx is presenting a poster at the thematic poster session at the ATS conference today from 11:30 AM PT / 2:30 PM ET to 1:15 PM PT / 4:15 PM ET.

Key Points: 
  • InflaRx is presenting a poster at the thematic poster session at the ATS conference today from 11:30 AM PT / 2:30 PM ET to 1:15 PM PT / 4:15 PM ET.
  • Tocilizumab, an anti-IL6R antibody, and baricitinib, a JAK inhibitor, are immunomodulators used in some patients as part of the standard of care treatment in this trial.
  • Day 60 all-cause mortality was 16.4% and 49.3%, respectively (HR 0.25; 95% CI:0.09-0.68, p=0.006), a significant relative reduction.
  • We believe this analysis further supports the life-saving potential of vilobelimab in the acute care setting and indicates our continued commitment to these patients.”

Biogen Receives Positive CHMP Opinion for TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA®

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星期四, 四月 25, 2024
BIIB, Biogen, Adalimumab, Methotrexate, Etanercept, Safety, Pharmacokinetics, European Commission, CHMP, Condylar resorption, Tocilizumab, European, Patient, Rheumatoid arthritis, EMA, Infliximab, Committee, Civil service commission, COVID-19, European Medicines Agency, Vaccine

CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE™ to the reference product ROACTEMRA®

Key Points: 
  • CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE™ to the reference product ROACTEMRA®
    CAMBRIDGE, Mass., April 25, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE™ (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA®1.
  • The CHMP’s positive opinion will now be referred to the European Commission (EC), which will decide whether to grant marketing authorization for TOFIDENCE.
  • “The positive CHMP recommendation for TOFIDENCE marks another positive step toward helping more people with inflammatory and immune-mediated conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen.
  • Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan).

Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®, its Third Approved Biosimilar in the U.S.

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星期一, 四月 15, 2024
Medical Supplies, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Oncology, Fresenius (company), Adalimumab, Pegfilgrastim, Biosimilar, Traction, Giant cell arteritis, Condylar resorption, Helios, Tocilizumab, Patient, Rheumatoid arthritis, Multimedia, Autoimmunity, Pharmaceutical industry

Fresenius, via its operating company Fresenius Kabi, announced today the immediate U.S. availability of Tyenne® (tocilizumab-aazg), a biosimilar of Actemra® (tocilizumab).

Key Points: 
  • Fresenius, via its operating company Fresenius Kabi, announced today the immediate U.S. availability of Tyenne® (tocilizumab-aazg), a biosimilar of Actemra® (tocilizumab).
  • (Photo: Business Wire)
    Michael Sen, CEO of Fresenius: “With the launch of Tyenne® in the U.S., we have reached another important milestone in accelerating our strong (Bio)Pharma momentum.
  • Tyenne® is Fresenius’ third approved biosimilar available in the U.S. and the second within its immunology portfolio.
  • Pierluigi Antonelli, CEO of Fresenius Kabi: “Tyenne® will impact the treatment landscape for inflammatory and immune diseases in the U.S.

Mustang Bio Reports Full-Year 2023 Financial Results and Recent Corporate Highlights

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星期一, 三月 11, 2024
Fast Track, ICT, ICV, Research, WM, Indolent lymphoma, XSCID, NHL, ASH, FDA, Birmingham School of Law, City, Cancer, DSM-IV codes, Mustang, Sale, Nature, Tocilizumab, GBM, Standard of care, Safety, Dexamethasone, Society, University, Mayo Clinic, Clinical professor, Translation, University of Washington, Foreign investment, Tumor microenvironment, Associate, CRS, Patient, Clinical trial, Disease, Survival, CFIUS, Cytokine release syndrome, Follicular lymphoma, Pharmaceutical industry

WORCESTER, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.

Key Points: 
  • WORCESTER, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.
  • Research and development expenses were $40.5 million for the year ended December 31, 2023, compared to $62.5 million for 2022.
  • 2023 and Recent Corporate Highlights:
    In July 2023, Mustang announced that it amended its previously announced asset purchase agreement with uBriGene (Boston) Biosciences Inc. (“uBriGene”) and closed the transaction.
  • In October 2023, Mustang completed a registered direct offering priced at-the-market for approximately $4.4 million in gross proceeds.

Mustang Bio Presents Updated Phase 1/2 Multicenter Clinical Data for MB-106 at the 2023 American Society of Hematology (ASH) Annual Meeting

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星期一, 十二月 11, 2023
Associate, University of Washington, Society, Follicular lymphoma, Clinical trial, Chronic lymphocytic leukemia, University, Dexamethasone, NHL, Tocilizumab, Abstract, DSM-IV codes, Cancer, Translation, Mustang, CRS, Patient, Safety, Pharmaceutical industry

WORCESTER, Mass., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced updated encouraging safety and efficacy data from Mustang’s multicenter Phase 1/2 clinical trial of MB-106, a CD20-targeted, 3rd-generation autologous CAR T-cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas (“NHL”) and chronic lymphocytic leukemia (“CLL”). The data were presented during a poster session on December 9th (Abstract #2102) at the 65th American Society of Hematology (“ASH”) Annual Meeting and build upon previously reported data from a single-institution Phase 1/2 clinical trial conducted at Fred Hutchinson Cancer Center (“Fred Hutch”). MB-106 is being developed in a collaboration between Mustang and Fred Hutch.

Key Points: 
  • The data were presented during a poster session on December 9th (Abstract #2102) at the 65th American Society of Hematology (“ASH”) Annual Meeting and build upon previously reported data from a single-institution Phase 1/2 clinical trial conducted at Fred Hutchinson Cancer Center (“Fred Hutch”).
  • MB-106 is being developed in a collaboration between Mustang and Fred Hutch.
  • “All nine patients have responded clinically to treatment in this multicenter trial and the safety and efficacy profile of MB-106 appears to be consistent with the original single-institution trial.
  • It is especially encouraging that complete responses were observed in all patients with follicular lymphoma in this multicenter trial,” said Mazyar Shadman, M.D., M.P.H., Study Chair, Innovators Network Endowed Chair at Fred Hutch, Associate Professor and physician at Fred Hutch and University of Washington.

FDA Approves TOFIDENCE™ (tocilizumab-bavi) a Biosimilar of ACTEMRA® developed by Bio-Thera Solutions

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星期日, 十月 8, 2023
III, Partnership, Pharmacokinetics, USFDA, Tocilizumab, Condylar resorption, Safety, FDA, Rheumatoid arthritis, Biogen, Methotrexate, Patient, Generic drug, Pharmaceutical industry, EU

The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

Key Points: 
  • The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
  • TOFIDENCE (BAT1806 / BIIB800) is Bio-Thera's first FDA approved product in the United States, and the first biosimilar developed and manufactured by a Chinese pharmaceutical company approved in the United States.
  • Developed by Bio-Thera, TOFIDENCE will be commercialized by Biogen in all countries excluding China (including Hong Kong, Macau and Taiwan).
  • The FDA approval of TOFIDENCE was based on a comprehensive analytical, non-clinical and clinical data package submitted by Biogen to the FDA in Sept 2022.

FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA®

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星期五, 九月 29, 2023
Biogen, BIIB, Pharmacokinetics, Methotrexate, Condylar resorption, Rheumatoid arthritis, Tocilizumab, Biosimilar, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, III, Food, Safety, Generic drug, Pharmaceutical industry, EU

TOFIDENCE is the first tocilizumab biosimilar approved in the United States.

Key Points: 
  • TOFIDENCE is the first tocilizumab biosimilar approved in the United States.
  • Since biosimilar entry in the US, medicines with biosimilar competition have experienced greater patient adoption equaling more than 150 million days of patient therapy1.
  • The FDA approval of TOFIDENCE was based on a comprehensive analytical, non-clinical and clinical data package submitted by Biogen to the FDA in Sept 2022.
  • The totality of evidence demonstrated TOFIDENCE is a biosimilar of the reference biologic.

Dr. Reddy’s Successfully Completes Phase I Study (IV Route) of DRL_TC, a Proposed Biosimilar of Tocilizumab

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星期一, 六月 5, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, BSE, Rituximab, Clinician Administered PTSD Scale, Therapy, Clinical trial, RDY, Pegfilgrastim, Rheumatoid arthritis, NSE, Tocilizumab, Patient, Male, NYSE, Safety, Roche, Generic drug, Pharmaceutical industry, EU

Reddy’s”), a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase I study.

Key Points: 
  • Reddy’s”), a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase I study.
  • This Phase I study used an intravenous (IV) formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Dr. Reddy’s tocilizumab biosimilar candidate in comparison to reference products.
  • Pharmacokinetic equivalence of DRL_TC to the EU reference medicinal product* and the U.S. reference product** was successfully demonstrated.
  • Dr. Reddy’s is developing the proposed tocilizumab biosimilar as both intravenous and subcutaneous formulations.

Global Biosimilars Business and Investment Opportunities - Analysis & Market Size by Technology, Clinical Trials, Patents, Financial Deals, Competitive Landscape - Q1 2023 Update - ResearchAndMarkets.com

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星期二, 四月 18, 2023
Biotechnology, Pharmaceutical, Health, Amgen, Asthma, CMS, Etanercept, Fresenius (company), Prevalence, Diabetes, Trastuzumab, Ustekinumab, Medicare, Inflation, Chronic condition, Patient, Analysis, Conditional sentence, Biosimilar, Rheumatoid arthritis, Centers for Medicare & Medicaid Services, Research, EMA, Tocilizumab, Ophthalmology, Fresenius, Knowledge, Growth, FDA, Celltrion, Legislation, Welfare, Arthritis, COVID-19, Cancer, Medicare Part D, Competitive landscape, Novartis, AbbVie, Inflation Reduction Act of 2022, Teva Pharmaceuticals, Biogen, Rituximab, Education, Eating, IRA, Sale, Movement, Scott Richter, Local Investing Opportunity Network, Physician, Fine chemical, Generic drug, Vaccine, Pharmaceutical industry, Natalizumab, Adalimumab, Ranibizumab

The "Global Biosimilars Business and Investment Opportunities - Analysis & Market Size by Technology, Clinical Trials, Patents, Financial Deals, Competitive Landscape - Q1 2023 Update" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Biosimilars Business and Investment Opportunities - Analysis & Market Size by Technology, Clinical Trials, Patents, Financial Deals, Competitive Landscape - Q1 2023 Update" report has been added to ResearchAndMarkets.com's offering.
  • In these volatile market conditions, the biosimilars market is still expanding dramatically, and the outlook is as promising.
  • It provides a detailed analysis of biosimilar market dynamics, covering clinical trials, patent data, financial deals, and company profiling details.
  • In addition, this report provides analyst commentary on key trends, drivers, strategies, innovations, and regulations in the field of biosimilars.