AMRI Expands Container-Closure Integrity Testing Services
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AMRI, a contract research, development, and manufacturing organization, plans to expand its container-closure integrity testing (CCIT) services into the European Union (EU). The company plans to build out custom laboratory…

Lonza Opens New R&D Center in South America
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Lonza has opened a research and development center in Salto, Uruguay. The Salto Technology Center (STC) will provide customized services in its six business areas: biosciences, consumer health and nutrition,…

Applied DNA Sciences Partners for Capsule-Authentication Tech
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ACG Group, a provider of products and services for capsule and tablet manufacturing, and Applied DNA Sciences, a Stony Brook, New York-headquartered molecular-based authentication service provider, have signed a memorandum…

Selexis, Xencor in Pact for Bispecific Antibodies
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Selexis SA, a Geneva, Switzerland-based provider of mammalian cell-line generation technology, has signed four commercial license agreements (CLAs) to extend its pact with Xencor, a Monrovia, California-based clinical-stage biopharmaceutical company…

GlaxoSmithKline Voluntarily Recalls Three Lots of Respiratory Inhalers in UK
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The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulatory authority, has issued a patient-level drug alert recalling three specific affected lots of respiratory inhalers manufactured by GlaxoSmithKline (GSK).…

FDA Cites Sun Pharmaceuticals’ Drug Manufacturing Facility
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The US Food and Drug Administration has cited a drug manufacturing facility in Gujarat, India of Sun Pharmaceutical Industries, a Mumbai, India-based pharmaceutical company, with three observations. The FDA conducted…

NIBRT Partners for US-Based Bioprocessing Training Center
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The National Institute for Bioprocessing Research and Training (NIBRT), a research and training institute for biomanufacturing in Ireland, has partnered with Jefferson (Philadelphia University + Thomas Jefferson University) to create…

FDA Cites Biocon for Insulin Manufacturing Facility in Malaysia
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The US Food and Drug Administration (FDA) has cited an insulin manufacturing facility in Malaysia of Biocon, a Bangalore, India-based pharmaceutical company, following a pre-approval inspection. Biocon announced the FDA’s…

Gilead Sciences’ Executive Vice President, Operations Retires
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Gilead Sciences has announced that its executive vice president of commercial operations, James Meyers, plans to retire. Meyers joined Gilead in 1996 as a regional sales director and was appointed…

Fresenius’ Closing of $4.3-Billion Acquisition of Akorn Faces Possible Issues with Data-Integrity Probe
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Fresenius Kabi, a specialty and generic pharmaceuticals company, may face issues with its pending $4.3-billion acquisition of Akorn, a Lake Forest, Illinois-headquartered specialty generic pharmaceutical company, following Akorn’s alleged breaches…