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Top Stories
The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product's biologics license application.
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The first generics of Lyrica have been approved by the FDA for neuropathic pain management and adjunctive therapy.
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Industry News
CHMP and CMDh have recommended that all marketing authorization holders (MAHs) of medicines containing liposomal drug delivery systems change the medicine name to avoid medication errors.
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NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.
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Supplier News
Fujifilm has bought Biogen ApS' Copenhagen facility for US$890 million.
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An affiliate of the Permira funds has signed an agreement to purchase Cambrex in an approximately $2.4-billion transaction.
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Bio/Pharma News
Alizé Pharma 3 completed a €67 million Series A financing round led by LSP to boost its product portfolio in rare endocrine and metabolic diseases.
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Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.
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Webinar Alert: B. cepacia complex (Bcc) Testing for Non-Sterile Water-Based Drug Products
Watch Eurofins BioPharma Product Testing’s on-demand webinar on B. cepacia complex (Bcc) testing, the absence of Bcc and FDA’s guidance on prevention and detection. Our expert will also cover the history, health risks, recalls and lessons learned, as well as a glimpse of the USP <60> draft for Bcc testing.
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Regulatory News
A US District Court in Washington, DC upheld FDA's interpretation of clinical need when choosing which substances are approved to use for drug compounding.
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Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.
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Exclusive Video from BIO:
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ANALYTICS
A design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.
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OUTSOURCING
A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.
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eBOOKS
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Biologics and Sterile Drug Manufacturing 2019
The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
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