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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®, its Third Approved Biosimilar in the U.S.
4/15/2024
Fresenius, via its operating company Fresenius Kabi, announced the immediate U.S. availability of Tyenne®, a biosimilar of Actemra®.
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U.S. Biotechnology Market Size to Increase USD 1.79 Trillion by 2033
4/12/2024
According to Nova One Advisor, the U.S. Biotechnology market size was estimated at USD 552.49 billion in 2023
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Heather, Greg and Tyler discuss a busy news week including Wegovy's label expansion, biosimilars, surprise donanemab delays for Eli Lilly and speculate on election impact.
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According to Fresenius Kabi, Tyenne is the first biosimilar to Genentech’s Acterma which has both IV and subcutaneous formulations approved by the FDA.
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Celltrion USA completes submission of Biologics License Application for CT-P47, a biosimilar candidate of ACTEMRA® (tocilizumab)
1/28/2024
Celltrion USA announced the submission of Biologics License Application to the U.S. Food and Drug Administration for CT-P47, a biosimilar candidate of the reference product ACTEMRA®.
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Alzheon Promotes Glenn E. Pauly to Chief Commercial Officer and Strengthens Commercial Organization with New Executive Appointments to Lead Planned U.S. Commercial Launch of Oral ALZ-801/Valiltramiprosate in 2025
12/5/2023
Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it has strengthened its commercial organization with the promotion of Glenn E. Pauly to Chief Commercial Officer and the appointments of Dina Lynch to Vice President of Market Access, and Nate Greene to Vice President of Brand Marketing.
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FDA Approves TOFIDENCE™ (tocilizumab-bavi) a Biosimilar of ACTEMRA® developed by Bio-Thera Solutions
10/8/2023
Bio-Thera Solutions, Ltd announced that its partner Biogen recently received notification from the United States Food and Drug Administration on the approval of TOFIDENCE intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA.
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FDA Roundup: October 3, 2023
10/3/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA®
9/29/2023
Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA.
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Pharmas, advocacy groups and regulatory bodies have made moves to put each other in legal crosshairs in 2023. Follow along with BioSpace’s Lawsuit Tracker to see what’s piling up on the docket.
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Dr. Reddy’s Successfully Completes Phase I Study (IV Route) of DRL_TC, a Proposed Biosimilar of Tocilizumab
6/5/2023
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. 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.
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HI-Bio Appoints Industry Veterans Uptal Patel, M.D., as Chief Medical Officer and Sunil Agarwal, M.D., as Board Member
4/18/2023
Human Immunology Biosciences (HI-Bio™), today announced the appointment of Uptal Patel , M.D., as Chief Medical Officer.
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The FDA has granted emergency use authorization to InflaRx’s vilobelimab, now to be marketed as Gohibic, for hospitalized adult patients with COVID-19, the German biotech announced Tuesday.
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Tonix Pharmaceuticals Announces Acquisition of Preclinical Infectious Disease Portfolio from Healion Bio, Inc.
2/2/2023
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an agreement whereby Tonix has acquired all of the assets of Healion Bio, Inc. (Healion) including its entire portfolio of next-generation antiviral technology assets.
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China NMPA Approves Bio-Thera Solutions’ BAT1806, A Biosimilar to Actemra® (Tocilizumab)
1/16/2023
Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage biopharmaceutical company, announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of Actemra ® (tocilizumab), in China.
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Belharra Launches with $130M From Versant, Genentech to Advance Chemoproteomics Platform (Updated)
1/4/2023
Backed by Versant and Genentech, Belharra Therapeutics launched Wednesday with $130 million in total financing to advance its novel chemoproteomics platform. -
FDA Approves Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults
12/21/2022
Genentech today announced that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab).
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Dr. Reddy’s Successfully Completes Phase 1 Study of DRL_TC, a Proposed Biosimilar of Tocilizumab
12/19/2022
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase 1 study.
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FDA Accepts Biogen Biologics License Application for BIIB800, A Biosimilar Candidate Referencing ACTEMRA® (tocilizumab)
12/9/2022
Biogen Inc. (Nasdaq: BIIB) – announced that the U.S. Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar candidate referencing ACTEMRA®1 (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody.