news
FDA approves Verzenio for metastatic breast cancer
The FDA has approved Verzenio to treat advanced or metastatic breast cancer that has progressed after taking therapy...
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Drug Manufacturing
news
FDA grants Breakthrough designation to Cemiplimab for CSCC
Cemiplimab receives FDA Breakthrough Therapy Designation for advanced cutaneous squamous cell carcinoma...
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FDA approves Mylotarg for treatment of acute myeloid leukemia
The FDA has approved Mylotarg for the treatment of adults with newly diagnosed acute myeloid leukaemia whose tumours express the CD33 antigen...
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FDA approves new antibacterial drug
The FDA has approved Vabomere for adults with complicated urinary tract infections...
article
Compressed gases: an important component of an environmental monitoring programme
The quality attributes of manufactured pharmaceutical products include the physical, chemical, and microbiological characteristics of the raw materials, excipients and active pharmaceutical ingredient (API), as well as the final drug product (see Table 1). Absence of microbiological contamination is considered a critical quality attribute due to its potential to dramatically…
news
Novartis receives EU approval for ribociclib
Novartis announced that the European Commission approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with metastatic breast cancer
article
Continuous manufacturing: regulatory and quality assurance challenges
During 2002, the United States Food and Drug Administration (FDA) requested rationalisation and modernisation of the manufacturing base for pharmaceutical production. This was in the hope that modernising the supply chain would enhance the robustness of manufacturing processes, thereby reducing product failures and, importantly, significantly enhancing product quality.1 The FDA’s…
whitepaper
Whitepaper: Development of an Efficient Manufacturing Process for Adenovirus
Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics. These challenges mostly arise from the size and complexity of the virus...
news
FDA grants approval of Besponsa for acute lymphoblastic leukaemia
The FDA has approved Besponsa for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia...
news
Bayer receives EU approval for Regorafenib
Bayer have announced the European Commission has granted marketing authorisation for Stivarga...
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BIOCAD does its sums for growth
Russian biotech company BIOCAD plans to leverage competitive advantages to take 5% of the European medicines market
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Pall Corporation Introduces Proprietary Bioreactor Control System
Pall Corporation, a leader in filtration, separation and purification, is pleased to introduce the mPath™ bioreactor control system to the biopharmaceutical market...
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Lonza Pharma&Biotech Launches Ibex™ Solutions – An Innovative New Concept in Biological Manufacturing and Development
Lonza’s commitment to constant innovation and adding value to its customers and partners is today demonstrated by the launch of Ibex™ Solutions – a unique addition to its current offering...
news
New Workflow Is First End-to-End Solution For Extrusion-Based Drug Implant Production
Thermo Scientific Pharma mini implant line is an automated, integrated system designed for continuous production of drug implants...
news
ISPE updates guidance on risk-based manufacturing
New ISPE guidance provides a scientific, risk-based approach for managing cross-contamination risk within shared facilities ...
