Eugene

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LATEST

Nitto Denko Avecia Opens New Cambridge Office in Massachusetts
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Nitto Denko Avecia, a Milford, Massachusetts-based manufacturer of industrial and life-science products, has opened a new corporate office in Cambridge, Massachusetts, to support its operations and corporate development activities. Nitto…

MHRA, CFDA Sign MoU for Info Exchange
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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has signed a memorandum of understanding (MoU) with the China Food and Drug Administration (CFDA) to exchange information on drug and…

FDA Plans Update for Risk-Based Inspections for Biologics
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The US Food and Drug Administration (FDA) has amended the general biologics regulations relating to the frequency of inspections by removing requirements for biennial inspection requirements to reflect the agency’s…

FDA Issues Draft Guidance on QIDP Designation for Anti-Infectives
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The US Food and Drug Administration (FDA) has issued draft guidance, Qualified Infectious Disease Product Designation Questions and Answers, to provide a resource for information on the FDA’s policies and…

Poseida Therapeutics Names VP, Technical Operations
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Poseida Therapeutics, a San Diego, California-based biopharmaceutical company developing cell therapies, has appointed Martin Giedlin, PhD, as vice president, technical operations. Giedlin has experience in cell-therapy process development, manufacturing, and…

Vetter Appoints BD Manager for South Korea Office
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Vetter Pharma, a Ravensburg, Germany-headquartered contract development and manufacturing organization for aseptic filling and final packaging of injectables, has appointed Michael Yi as business development manager for Vetter Pharma International…

UPM Pharmaceuticals Appoints Quality Control VP
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UPM Pharmaceuticals, a contract development and manufacturing organization focused on solid oral and semi-solid dosage forms, has appointed Daniel Dixon to the position of vice president of quality control (QC).…

Amgen To Invest $300 Million for New US Biomanufacturing Plant
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Amgen has announced a five-year capital investment plan of $3.5 billion, which includes a new $300-million manufacturing plant in the US. Amgen made the announcement in its full-year and fourth-quarter…

FDA Issues Warning Letter to Japanese API Manufacturer
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The US Food and Drug Administration (FDA) has issued a Warning Letter to Daito Kasei Kogyo, an Osaka, Japan-headquartered active pharmaceutical ingredient (API) manufacturer, for deviations from current good manufacturing…

FDA Issues Warning Letter to Celltrion for Biosimilars Plant
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Celltrion, an Incheon, Korea-based life-sciences company, has received a Warning Letter (dated January 26, 2018) from the US Food and Drug Administration (FDA) for good manufacturing practice (GMP) violations for…