FDA, Gov’t of India Partner in Enforcement Operation Against Unapproved Rx Drugs
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The US Food and Drug Administration (FDA) reports that its first bilateral enforcement operation with the Government of India stopped approximately 500 shipments of illicit and unapproved prescription drugs and…

WuXi Vaccines Signs 20-Year, $3-Bn Mfg Contract with Global Vaccine Company
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WuXi Vaccines, a vaccine CDMO and joint venture between WuXi Biologics and Shanghai Hile Bio-technology, has entered into a strategic partnership with an undisclosed global vaccine company and signed a 20-year…

Roche Completes $1.4-Bn Acquisition of Biopharma Company Promedior
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Roche has completed its previously announced acquisition of Promedior, a Lexington, Massachusetts-based clinical-stage biopharmaceutical company focused on developing drugs for fibrotic diseases, in an approximate $1.4-billion deal (upfront cash payment…

Astellas’ Audentes to Build Gene-Therapy Mfg Facility
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Audentes Therapeutics, an Astellas company focused on developing adeno-associated virus-based genetic medicines, plans to invest $109 million to build a new 135,000-square-foot gene-therapy manufacturing facility in Sanford, North Carolina. The…

WHO, Funders Set Priorities for Coronavirus Research
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Health experts, researchers, and major funders met at the World Health Organization headquarters in Geneva this week (week of February 10, 2020) to prioritize research and funding to address the…

HHS, Janssen Join To Develop Coronavirus Vaccine
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Johnson & Johnson’s Janssen reports it will further expedite its investigational coronavirus (COVID-19) vaccine program through an expanded collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of…

A&C, Comar Expand; MilliporeSigma in Excipient Pact
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The latest news from CDMOs, CMOs, and suppliers featuring MilliporeSigma, A&C, Comar, Velesco, and ACG Inspection.  Chemicals/Chemical APIs A&C Expands with New Bio Buffer Facility in Ireland A&C, a manufacturer…

Global Pharma Briefs: News from Asia, Australia, Europe, and the US
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A roundup of developments from Australia (CSL), Germany (Bayer), India (Lupin, Wockhardt), and the US (GE). Australia CSL Partners with University of Queensland to Develop Coronavirus Vaccine CSL, a biotechnology…

FDA Issues Six Final Guidances, One Draft on Gene-Therapy Mfg and Development
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The US Food and Drug Administration (FDA) has issued six final guidances relating to manufacturing and clinical development of gene therapies and a draft guidance relating to gene therapies and…

Novo Nordisk To Invest $117 M in Diabetes-Drug Production Facilities
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Novo Nordisk plans to invest DKK 800 million ($117 million) to upgrade and expand facilities at its production site in Kalundborg, Denmark, which currently manufacture a range of products for…