Top Stories
President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
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The acquisition is expected to strengthen Novartis’ gene therapy pipeline.
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Industry News
Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.
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The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.
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Supplier News
A new facility will allow Fette Compacting to double its production capacity for tablet presses in Nanjing, China.
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The companies have extended a contract agreement for the commercial manufacture of the active pharmaceutical ingredient for vonapanitase, an investigational drug intended to improve hemodialysis vascular access outcomes.
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Bio/Pharma News
The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).
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Eli Lilly will acquire ARMO BioSciences to strengthen Lilly's immuno-oncology program.
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DCAT Sharp Sourcing: Learn. Connect. Optimize.
Delivering fresh insights to optimize the pharma customer–supplier relationship. DCAT Sharp Sourcing 2018 is a conference and networking event that provides peer and customer insight on the best practices and practical ways for optimizing pharmaceutical manufacturing and supply networks. Join us at the Hyatt Regency in New Brunswick, New Jersey on Tuesday, June 26th.
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Regulatory News
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
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The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.
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DOSAGE FORMS
Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.
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ASEPTIC/STERILE
Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.
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FORMULATIONS
Choice of carrier can have a significant impact on the capsule filling process as well as the performance of the DPI formulation.
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MANUFACTURING
Integrated computerized systems for data collection improve data security and offer a solution for handling temporary data.
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Events
May 29–30, 2018
June 4–7, 2018
June 14–15, 2018
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eBOOKS
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible. |
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