Eugene

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LATEST

CMO Olon Buys API Manufacturing Plant in India
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Olon S.p.A., an Italy-headquartered contract development and manufacturing organization of active pharmaceutical ingredients (APIs) and a generics supplier, has acquired a local generics chemical operations API manufacturing facility in Mahad,…

FDA Publishes Site-Selection Model for Inspecting Foreign Mfg Facilities
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The US Food and Drug Administration (FDA) has published an internal policy that outlines the agency’s risk-based, site-selection model for inspecting foreign drug-manufacturing facilities and has highlighted other ways in…

New Molecular Entity Approvals: FDA OKs Two Merck & Co.’s HIV Drugs
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The US Food and Drug Administration (FDA) has approved Merck & Co.’s two new HIV-1 medicines: Delstrigo, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg)…

BioMarin To Invest $43 Million in Fill / Finish Line at Plant in Ireland
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BioMarin, a San Rafael, California-based biopharmaceutical company, is investing $43 million in a new drug-product filling project at its Shanbally, County Cork, Ireland facility, according to information from IDA Ireland,…

FDA Updates Agency Investigation into Valsartan Impurities
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The US Food and Drug Administration (FDA) has provided an update on its investigation into an impurity found in certain samples of valsartan, which is used to treat high blood…

Emergent Buys Specialty Pharma Company Adapt Pharma for $735 Million
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Emergent BioSolutions, a Rockville, Maryland-based specialty biopharmaceutical company and contract manufacturer, has agreed to acquire Adapt Pharma, a Dublin, Ireland-based specialty pharmaceutical company, and its leading product Narcan (naloxone HCl)…

Boehringer Ingelheim Breaks Ground on $100-Million Facility for Solid-Dose Drugs
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Boehringer Ingelheim (BI) has broken ground to construct a new production facility for solid-dose drugs in Ingelheim am Rhein, Germany. This new solids launch facility will focus on development activities…

WuXi AppTec Appoints Co-CEO
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WuXi AppTec, a Shanghai, China-headquartered contract service provider, has appointed Edward Hu, the company’s Chief Financial Officer (CFO), as Co-Chief Executive Officer (CEO) of the company. Hu will continue to…

AGC Biologics Expands Capacity at Denmark Facility
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AGC Biologics, a Bothell, Washington-headquartered contract development and manufacturing organization of biologics, is increasing manufacturing capacity at its Copenhagen, Denmark facility. The Copenhagen facility will add a single-use bioreactor “6Pack”…

EC OKs Novartis’ CAR-T Cell Therapy Kymriah
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The European Commission (EC) has approved Novartis’ Kymriah (tisagenlecleucel), a chimeric antigen receptor (CAR) T-cell therapy, for two indications in leukemia and lymphoma. Kymriah was the first CAR-T cell therapy…