Pharmaceutical Outsourcing covers news of importance to the contract services segment of the pharmaceutical industry.
Collected from the most trusted on-line resources, these news stories are chosen and published here based on their relevance to the pharmaceutical industry.
Topics of interest typically include: mergers and acquisitions, service additions, new capabilities, personnel changes, news from the FDA and other international regulatory and standard-setting agencies, and new outsourcing contracts and deals.
If you are looking to stay up-to-date with the news in your industry, this resource is vital for your industry knowledge.
Amgen announced the groundbreaking of its new next-generation biomanufacturing plant that will be constructed at its West Greenwich, R.I. campus.
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BIA Separations announced it is collaborating with AveXis to enhance the commercial purification process for its gene therapy pipeline, beginning with Zolgensma®.
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Lubrizol announces the acquisition of Bavaria Medizin Technologie GmbH, a designer and manufacturer of both intravascular and nonvascular devices, by its German subsidiary Lubrizol Deutschland GmbH.
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Rising Pharmaceuticals announced the U.S. launch & commercial shipment of a generic version of Lyrica®, (pregabalin) Capsules, in all eight commercially available strengths.
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OnKure entered into an exclusive license and option agreement with KDAc Therapeutics to support the continued development of KDAc’s selective histone deacetylase 3 (HDAC3) inhibitor program.
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Arkivum has achieved pharma-level compliance with the award of ISO 9001:2015 certification, demonstrated alignment with data-related GxP regulations.
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Uman Diagnostics and Bio-Techne announced a strategic License and Supply Agreement for the antibodies used in the quantification of Nf-L on the ProteinSimple™-branded Ella™ immunoassay platform.
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Dr. Reddy’s Laboratories has announced the launch of Ramelteon Tablets, 8 mg, a therapeutically equivalent generic version of Rozerem® (ramelteon, 8 mg) Tablets.
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Samsung Bioepis announced the FDA has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab).
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Ligand Pharmaceuticals has announced the signing of an agreement with Ab Initio Biotherapeutics whereby Ligand will acquire Ab Initio for $12 million in cash.
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STA Pharmaceutical announced its ASU in Shanghai and API process R&D and manufacturing facility in Changzhou, have successfully passed two inspections from the FDA.
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Lonza announced the start of expansion to its bioconjugation facility in Visp, Switzerland together with the successful commercial approval of a third ADC produced at the site.
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ICON announced the appointment of Julie O’Neill as a non-executive director.
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Jubilant Cadista Pharmaceuticals is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg, 28x3 Blister Pack/Carton to the consumer level.
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Cytel announced that it will launch East On Demand™ at the annual Joint Statistical Meetings (JSM) 2019.
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