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Top Stories
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA's recently proposed draft guidance for analytical assessment of similarity in biosimilars.
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Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.
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PharmTech 2017 Employment Trends
The editors of Pharmaceutical Technology invite you to participate in the annual employment survey for individuals involved in bio/pharmaceutical development, formulation, or manufacturing.
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Overcoming Resistance and Migrating to Content Automation
Automation can help organizations in the life sciences streamline a content delivery process that may already be strained by quality controls, limited resources, or compliance issues.
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Industry News
In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.
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The agency and the European Commission published updated guidance to answer questions about Brexit.
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Supplier News
Binding Site has introduced a number of new monoclonal antibodies targeting infectious diseases, including cytomegalovirus, hepatitis (A, B, C, and D), herpes, human immunodeficiency virus (HIV), rubella, and toxoplasma.
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Avista Pharma Solutions facility and equipment upgrades at its Longmont, Colorado facility support processing of potent compounds.
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Bio/Pharma News
The acquisition deepens Astellas' involvement in the development of a pipeline of therapeutics focused on mitochondrial function.
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The company has opened a new California facility that, combined with its existing site in Foster City, CA, will quadruple its laboratory footprint for gene therapy products.
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Regulatory News
During the November meeting of the agency's Pharmacovigilance Risk Assessment Committee, review of Esmya (ulipristal acetate) was announced as well as warnings about prostate cancer treatments.
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FDA has approved Mylan's biosimilar to Roche's blockbuster anti-cancer biologic, Herceptin.
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Fill/Finish
Alternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility.
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Vaccines
Despite the challenges and high cost of development, vaccine innovation is at an all-time high, as new approaches aim to improve global access.
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Manufacturing
The European Commission's effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.
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eBOOKS
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Vaccines Development and Manufacturing 2017
New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics. |
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