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GxP Systems Validation: Not A One-Time Occurrence

Jan 31, 2023
An organization’s good “x-variable” practice (GxP) system is only as reliable as its validated state. Once a system is identified as a GxP system, the validation work has only just…
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Charles River Laboratories Acquires SAMDI Tech

Jan 30, 2023
Charles River Laboratories International, Inc. announced that it has acquired SAMDI Tech, Inc, a leading provider of high-quality, label-free high-throughput screening (HTS) solutions…
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Sandoz receives positive CHMP opinion for citrate-free high concentration formulation of adalimumab…

Jan 30, 2023
Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency…
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Xeris Biopharma Announces FDA Grants Orphan-drug Exclusivity for Recorlev

Jan 30, 2023
Xeris Biopharma Holdings, Inc., a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of…
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Dupixent (dupilumab) approved by European Commission as the first and only targeted medicine…

Jan 30, 2023
The European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE) in adults and…
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Nanoscope Therapeutics Receives Fast Track Designation by the FDA for MCO-010 for the Treatment of…

Jan 30, 2023
Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, announced that the U.S. Food and Drug Administration…
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Rewind Therapeutics Raises Additional Funding and Adds Sunstone Life Science Ventures A/S as New…

Jan 30, 2023
Rewind Therapeutics announced that it has raised additional funding, with Sunstone Life Science Ventures A/S joining as a new investor and with participation of existing investors…
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Evotec announces agreement with Janssen to develop immune-based therapies

Jan 27, 2023
Evotec SE announced that the Company has entered into a strategic collaboration and licence agreement with Janssen Biotech, Inc. (“Janssen”), one of the Janssen Pharmaceutical Companies…
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Roche launches COVID-19 PCR test to detect the fast spreading XBB.1.5 Omicron sub-variant

Jan 27, 2023
Roche and its subsidiary TIB Molbiol have developed a COVID-19 PCR test for researchers that detects and differentiates the latest variant of concern, XBB.1.5. The XBB.1.5 variant is…
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European Medicines Agency accepts Marketing Authorization Application for lecanemab as treatment for…

Jan 26, 2023
BioArctic AB's (publ) partner Eisai announced that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab, an investigational…
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