Eugene

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LATEST

Gilead Sciences Names Roche Executive as New Chairman and CEO; Roche Pharmaceuticals Names New CEO
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Gilead Sciences has appointed Daniel O’Day, currently Chief Executive Officer (CEO) of Roche Pharmaceuticals, as Chairman of the Board of Directors and CEO of Gilead, effective March 1, 2019. John…

FDA Withdraws Proposed Rule in Efforts to Modernize Generic Drug Labels
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The US Food and Drug Administration (FDA) is withdrawing a proposed rule from 2013 that, if finalized, would have allowed generic drug makers to independently—meaning, without prior FDA review and…

FDA Takes Steps to Improve Oversight of Data Integrity
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The US Food and Drug Administration (FDA) has issued final guidance, Data Integrity and Compliance With Drug CGMP, which updates a 2016 guidance for ensuring data integrity and compliance with…

Boehringer Ingelheim Announces Restructuring in France
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Boehringer Ingelheim (BI) has announced staff reductions in France as part of a post-integration plan of Sanofi’s animal-health business (Merial), which BI acquired in 2017. The reorganization includes the elimination…

Mylan Expands Nationwide Recall of Valsartan Tablets
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Mylan Pharmaceuticals is expanding its consumer-level voluntary US recall of valsartan-containing products to include all lots of valsartan-containing products within expiry. In November 2018, Mylan issued a voluntary recall to…

Chinese Pharma Company Invests $145 Million in Manufacturing Plant
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Changzhou Qianhong Bio-pharma, a Changzhou, China-headquartered pharmaceutical company, has begun the second phase of construction of a manufacturing facility in Changzhou National Hi-Tech District, with a 1-billion yuan ($145-million) investment.…

FDA Cites 22 Observations at Lupin’s India Mfg Site
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Lupin, a Mumbai, India-headquartered pharmaceutical company, has received 22 observations from the US Food and Drug Administration (FDA) across its three facilities in Mandideep, India, which Lupin says are “largely…

Catalent, ABL Expand
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A roundup of the latest news from suppliers, contract development and manufacturing organizations and contract manufacturing organizations, featuring Catalent Pharma Solutions and ABL. Biologics manufacturing ABL Expands Viral Vector Manufacturing…

Janssen, Argenx in $1.6-Billion Cancer Drug Deal
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Janssen Pharmaceuticals, one of the pharmaceutical companies of Johnson & Johnson, and argenx, a clinical-stage biotechnology company developing differentiated antibody-based therapies for treating severe autoimmune diseases and cancer, have formed…

AGC To Acquire Boehringer Ingelheim’s API Mfg Plant in Spain
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AGC, a Tokyo-headquartered manufacturer of glass, chemicals, and specialty materials, has agreed to acquire Boehringer Ingelheim’s (BI’s) Malgrat Pharma Chemicals (MPC), a subsidiary of BI in Spain that manufactures intermediates…