Category Archives: Manufacturing

Pharma Manufacturing Investments Reflect Key Industry Trends

Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments. Pharmaceutical Technology’s Cynthia Challener offers summary of selected investments in both small- and large-molecule manufacturing facilities during the last year. Numerous trends in the pharmaceutical industry, and particularly in the biopharmaceutical sector, are leading to the need for smaller-capacity production facilities, which in […]
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Five Steps to Data Integrity

Siegfried Schmitt offers some steps that manufacturing companies can take to ensure data integrity. In general, media tend to report on the most serious data integrity violations uncovered by regulators. Often when companies find similar issues through their own internal investigations, they remain confidential and unreported. It would, therefore, be presumptuous to assume violations reported on […]
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EU Steps Up Manufacturing Inspection Efforts

One of EMA’s key objectives this year is improvements in dealing with the “causes and impact of shortages of human medicines caused by GMP non-compliance and quality defects”. The European Directorate for the Quality of Medicines & Healthcare, which is responsible for the European Pharmacopoeia but also runs its own inspection operations, has been tightening […]
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Turkey to See Renewed Multinational Investment, Says Report

Turkey is remains a key destination for foreign investment, and the next five years should see renewed interest from pharma multinationals, says a new report by CPhI Worldwide. Although the Turkish government’s price referencing system and fixed euro-lira conversion rate have presented a major obstacle for pharma growth, the report states that these pricing challenges […]
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Paying for the Future of Medicine

Is the hallmark of innovation higher drug prices? The three leading justifications for sticker-shocking drug prices in the US, from the biopharma perspective, are: 1) it costs a lot to bring a drug to market;* 2) drugs – even very expensive ones – are cheaper in the long run since they prevent complications, hospitalizations and […]
Also posted in Biotech, FDA, healthcare, leadership, Market Access, pricing, R&D, Regulatory, Technology | Tagged , , , , , , | 1 Comment
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