Eugene

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LATEST

EMA Updates Guidances in Preparation for Brexit
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The European Medicines Agency (EMA) has updated two guidances designed to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU) (i.e., Brexit). The EMA…

Oncobiologics Launches CDMO Biz; Forms First Contract
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Oncobiologics, a Cranbury, New Jersey-based biopharmaceutical company developing monoclonal antibody (mAb) biosimilars, has launched a contract development and manufacturing (CDMO) business. It further formed a master services agreement (MSA) with…

Celltrion Resubmits to FDA Proposed Biosimilar of Roche’s Blockbuster Drug Herceptin
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Celltrion, an Incheon, South Korea-based biopharmaceutical company of biosimilars and innovator drugs, has resubmitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for its biosimilar…

MilliporeSigma, HistoCyte in Distribution Pact
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MilliporeSigma has signed an agreement with HistoCyte Laboratories, a Tyne, UK-based cell-line technology company, to be the exclusive multinational distributor of HistoCyte’s portfolio of cell-line reference products for immunohistochemistry and…

Glenmark Gets FDA OK for First Generic at New NC Mfg Site
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Glenmark Pharmaceuticals, a Mumbai, India-headquartered pharmaceutical company, has received approval of its first abbreviated new drug application by the US Food & Drug Administration (FDA) made at the company’s new…

Pacira, Nuance Biotech in License Pact in China
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Pacira Pharmaceuticals, a Parsippany, New Jersey-based specialty pharmaceutical company, and Nuance Biotech, a Shanghai, China-based specialty pharmaceutical company, have formed an agreement to develop and commercialize Exparel (bupivacaine liposome injectable…

Sanofi Completes $4.8-Billion Acquisition of Biopharm Company Ablynx
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Sanofi has completed its $4.8-billion acquisition of Ablynx, a Ghent, Belgium-based biopharmaceutical company focused on developing and commercializing proprietary therapeutic proteins based on single-domain antibody fragments. The deal was announced…

Roche To Acquire Foundation Medicine in $2.4-Billion Deal
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Roche has agreed to acquire full ownership of Foundation Medicine’ a Cambridge, Massachusetts-based molecular information company, by acquiring the outstanding shares not already owned by Roche for approximately $2.4 billion.…

Minakem Plans Opening of High-Containment API Mfg Facility
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Minakem, the contract development and manufacturing division of Minafin, a Mont-Saint-Guibert, Belgium-based fine chemicals producer, plans to open a new closed-controlled environment high-containment production facility in August 2018 at the…

Marken To Move Chicago Operations to New Full-Service Facility
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Marken, a Research Triangle Park, North Carolina-based provider of logistics and supply-chain services for clinical trial materials, is relocating its Chicago logistics hub into a new, larger facility near the…