FDA Approves Pfizer’s Gene Therapy for Adults with Hemophilia B
BioPharm International
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2d ago
Beqvez (fidanacogene elaparvovec-dzkt), a one-time gene therapy, helps adults with hemophilia B produce factor IX themselves instead of receiving regular intravenous infusions ..read more
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Vertex and TreeFrog Therapeutics Enter Licensing Agreement and Partnership on Production of Type 1 Diabetes Cell Therapies
BioPharm International
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2d ago
The collaboration aims to scale-up TreeFrog’s process to produce and amplify cells for Vertex’s type 1 diabetes cell therapies ..read more
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European Commission Approves Tislelizumab for Non-Small Cell Lung Cancer
BioPharm International
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3d ago
The approval, given across three indications, follows a previous approval for second-line use in esophageal squamous cell carcinoma ..read more
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FDA Grants Priority Review for Expanded Indication of GSK’s Jemperli
BioPharm International
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4d ago
GSK’s supplemental Biologics License Application for its PD-1-blocking antibody therapy has been accepted for review by FDA ..read more
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A Deep Dive on Sterile Powder Transfer for Parenteral Fill/Finish (INTERPHEX 2024)
BioPharm International
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4d ago
At INTERPHEX 2024, BioPharm International spoke with Mary Van Gaasbeck, technical services specialist, LS Equipment and Services, at STERIS Life Sciences, about how to effectively conduct sterile powder transfer during the fill/finish step in parenteral drug product manufacturing ..read more
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How the Single-Use Trend Benefits Pumping Systems and Fluid Handling (INTERPHEX 2024)
BioPharm International
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4d ago
Current trends, such as single-use technologies, presen advantages and new challenges for pumping systems, according to Andreas Frerix, product management director for Quattroflow at PSG Biotech ..read more
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Reducing Variability and Time to Results Using Automated Cell-Based Assays
BioPharm International
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4d ago
Implementing automation involves careful optimization and fine-tuning of various parameters to ensure the accurate execution of cell-based potency assays ..read more
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New Regulations Influence Design of Bio/Pharmaceutical Manufacturing Facilities (INTERPHEX 2024)
BioPharm International
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5d ago
As the industry adjusts to new regulations, including Annex 1, bio/pharma manufacturers must rethink facility designs to remain in compliance ..read more
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Discussing Impact on Sensor Technologies from Industry Trends (INTERPHEX 2024)
BioPharm International
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5d ago
At INTERPHEX 2024, Jay Rajagopalan, senior director—Engineering & Product Management for Malema at PSG Biotech, discussed how the advancement of sensor technologies are being shaped by current industry trends ..read more
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USP Becomes a Member of BARDA’s BioMaP-Consortium
BioPharm International
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5d ago
The BioMaP-Consortium includes members of the biopharmaceutical industry and supports BARDA ..read more
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