Tocilizumab

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

Retrieved on: 
Thursday, April 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.

Retrieved on: 
Monday, April 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

Retrieved on: 
Monday, March 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

Retrieved on: 
Monday, December 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

Retrieved on: 
Sunday, October 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®

Retrieved on: 
Friday, September 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

Retrieved on: 
Monday, June 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

Retrieved on: 
Tuesday, April 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.

Annals of Rheumatic Diseases Publishes Results from Phase 2 Study of emapalumab in Patients with Secondary HLH/Macrophage Activation Syndrome

Retrieved on: 
Tuesday, April 4, 2023
Medical Affairs Bureau, Research and development, Swedish Orphan Biovitrum, Pediatrics, Glucocorticoid, Emapalumab, Macrophage, Annals of the Rheumatic Diseases, HLH, MAS, Cincinnati Children's Hospital Medical Center, AOSD, Tocilizumab, Development, Annals, Patient, Division, Bambino, Hospital, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Laboratory, Food, Safety, Disease, Pharmaceutical industry, Rheumatology

In the published study, 14 patients with sJIA or AOSD and sHLH/MAS who did not respond to high-dose glucocorticosteroids received emapalumab.

Key Points: 
  • In the published study, 14 patients with sJIA or AOSD and sHLH/MAS who did not respond to high-dose glucocorticosteroids received emapalumab.
  • All 14 patients completed the trial, entered long-term follow-up and were alive at the end of follow-up.
  • Based on the results of this study, Sobi decided to continue to evaluate emapalumab in this patient population and initiated the EMERALD phase 3 study, which is ongoing.
  • “We remain committed to evaluating emapalumab as a potential new treatment option for patients affected by this severe condition.

Enlivex Announces Issuance of Israeli Patent Covering the Use of Allocetra™ to Prevent Cytokine Release Syndrome (CRS) Resulting from CAR T-Cell Therapy, Infectious Diseases or Any Non-Infectious Source of CRS

Retrieved on: 
Wednesday, February 15, 2023
Well, Patent, SARS, Collection, Gram, Infection, Tocilizumab, Acute respiratory distress syndrome, CAR, Immunotherapy, CAPS, De novo, HLH, LPS, Smallpox, Acute pancreatitis, Cancer, NLRP3, CINCA, MAS, Sepsis, Patient, Macrophage activation syndrome, Muckle–Wells syndrome, Inhalation, GPI, Therapy, FCAS, FDA, Hemophagocytic lymphohistiocytosis, Trauma, Severe acute respiratory syndrome outbreak, MWS, Cytokine release syndrome, Malaria, FCU, Vaccine

Nes-Ziona, Israel, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of an Israeli patent, numbered 284985, entitled, “Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment.” The patent provides added intellectual property protection in Israel into at least 2037, with claims covering the use of for Allocetra™ for prevention or amelioration of cytokine storms in cancer patients receiving CAR-T therapy, as well as in patients whose cytokine storms result from infectious diseases or non-infectious sources.

Key Points: 
  • Nes-Ziona, Israel, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of an Israeli patent, numbered 284985, entitled, “Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment.” The patent provides added intellectual property protection in Israel into at least 2037, with claims covering the use of for Allocetra™ for prevention or amelioration of cytokine storms in cancer patients receiving CAR-T therapy, as well as in patients whose cytokine storms result from infectious diseases or non-infectious sources.
  • CAR T-cells are T-cells that have been genetically modified to include a receptor that allows them to specifically target and destroy cancer cells.
  • While certain CAR T-cell treatments were recently approved by the FDA in several cancer indications, such treatments have been associated in many patients with a side effect named cytokine release syndrome, which describes a collection of potentially severe or life-threatening symptoms that stem from over-activation of immune pathways.
  • Preclinical data indicate that Allocetra™ has the potential to prevent or ameliorate cytokine release syndrome associated with CAR T-cell therapies.