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Teva Faces Possible Delays on Migraine Drug Candidate Over Mfg Issues at Celltrion API Mfg Plant
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Teva Pharmaceutical Industries is facing possible delays for its migraine drug candidate, fremanezumab, following a Warning Letter issued by the US Food and Drug Administration (FDA) to Celltrion, an Incheon,…
AstraZeneca Resolves Mfg Issues for Potential Blockbuster Hyperkalemia Drug
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AstraZeneca has resolved manufacturing issues at its manufacturing facility in Coppell, Texas for its investigational drug, ZS-9 (sodium zirconium cyclosilicate), a drug for treating hyperkalemia (high potassium levels in the…
Charles River To Acquire CRO MPI Research
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Charles River Laboratories International, a Wilmington, Massachusetts-headquartered contract research organization (CRO), has agreed to acquire MPI Research, a Mattawan, Michigan-headquartered non-clinical contract research organization (CRO), for approximately $800 million. MPI…
Cytovance Biologics Completes First Batch in New Microbial Mfg Facility
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Cytovance Biologics, an Oklahoma City, Oklahoma-based biologics contract manufacturer, has completed its first batch in its new 1000-liter microbial manufacturing facility. The 30,000-square foot facility houses a 14-liter fermentor, a…
Horizon Discovery in Biomfg Pact
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Horizon Discovery Group, a Cambridge, UK-headquartered gene-editing technology company, has signed a non-exclusive out-licensing agreement with an undisclosed US-based immuno-oncology therapeutics developer, for Horizon’s proprietary technologies to support the development…
