Top Stories
The new progesterone active pharmaceutical ingredient, used captively by Pfizer for the past four years, reduces carbon footprint by more than 70%.
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The FDA commissioner outlined the agency’s initiatives to reward innovation and biosimilars development.
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Industry News
GlobalData reports the need to shift away from egg-based manufacturing of vaccines in light of influenza-related deaths.
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The company is recalling Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g manufactured by Gland Pharma Ltd and distributed by Sagent due to out-of-specification impurity results.
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Supplier News
In selling its contrast media business, Hovione will focus on API and drug product development and manufacturing.
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Grand River Aseptic Manufacturing announces first planned investment in capacity expansion.
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Bio/Pharma News
Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.
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The $11.6-billion acquisition strengthens Sanofi’s position in hematology and specialty medicines.
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Regulatory News
The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen’s multiple sclerosis drug Zinbryta (daclizumab beta).
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Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
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EXCIPIENTS
This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.
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STANDARDS & REGULATIONS
In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.
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ANALYTICS
Stability testing on APIs/finished drug product helps define optimal drug packaging for shelf-life storage.
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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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