The Importance of Characterization in Biosimilars Development
Industry experts discuss the requirements and challenges involved in getting biosimilar products from bench to launch.

Advancing Chiral Chemistry in Pharmaceutical Synthesis
Developments involve stereoretentive cross-coupling, enantioselective alcohol silylation, strategies for amplifying signals in circular dichroism spectroscopy, and a synthetic route for the natural product ingenol.

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The Basics of Measurement Uncertainty in Pharma Analysis
How good is reportable value?

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GSK Agrees to Sell Thrombosis Brands and Manufacturing Site to Aspen
GlaxoSmithKline’s sale of its thrombosis brands is part of a focus on its late-stage pipeline.

Fujifilm Diosynth Biotechnologies Opens New Manufacturing Facility
Fujifilm Diosynth Biotechnologies’ new mammalian cell-culture facility uses primarily single-use technologies.

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Ben Venue to Cease Production
The sterile injectable manufacturer Ben Venue decides to end production despite efforts to remediate cGMP violations.

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FDA Updates Foreign Operations
Budget issues and changing global markets are prompting FDA to revise its growing network of overseas offices.

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US Government Establishes Fill–Finish Network
The US Department of Health and Human Services awards contracts to four companies for fill–finish manufacturing for pandemic influenza vaccines.

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FDA Activities Continue During Government Shutdown
During the ongoing federal government shutdown, FDA activities will be limited to work involving the safety of human life or the protection of property, and activities funded by carryover user fee balances PDUFA, GDUFA, and MDUFA.

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Hovione Passes 12th FDA Inspection
Hovione's plant in Portugal has successfully passed its 12th FDA inspection in 18 months.

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