EMA Expects Less Supply Disruptions Resulting from Brexit
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The European Medicines Agency (EMA) has revised the number of centrally authorized medicines (CAPs) for which there are concerns of supply disruptions due to the UK’s exit from the European…

Novo Nordisk To Establish US Mfg Site for Stem Cell-Based Therapies; Signs Insulin Pen Pacts
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Novo Nordisk plans to establish a manufacturing site in Fremont, California to develop and produce stem cell-based therapies. The company has signed a long-term lease on a GMP facility, previously…

Pfizer’s Ian Read To Transition CEO Role to Pfizer COO in 2019
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Ian Read, Chief Executive Officer and Chairman, Pfizer will step down as CEO, effective January 1, 2019, with Albert Bourla, the company’s current Chief Operating Officer (COO), assuming the role…

Dr. Reddy’s Sells Antibiotic Mfg Plant to Neopharma
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Dr. Reddy’s Laboratories, a Hyderabad, India-headquartered pharmaceutical company, has sold its antibiotic manufacturing facility and related assets in Bristol, Tennessee to Neopharma, a pharmaceutical company headquartered in Abu Dhabi, United…

Fresenius Gets Favorable Court Ruling in Ending Merger with Akorn
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Following a court ruling, Fresenius, a specialty and generic pharmaceuticals company, has legally terminated its $4.75-billion merger with Akorn, a Lake Forest, Illinois-headquartered specialty generic pharmaceutical company. In April 2018,…

Novartis Plans Staff Reductions in Manufacturing and Business Support Services
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Novartis has announced staff reductions in manufacturing and business services operations in Switzerland and manufacturing in the UK.   The company explained the rationale for the changes and the staff…

CDMO/CMO Roundup: Cambrex Creates Center of Excellence; AGC Biologics Expands
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Cambrex, a contract manufacturing organization of small-molecule active pharmaceutical ingredients (APIs), and AGC Biologics, a Bothell, Washington-based contract development and manufacturing organization of biologics, have announced plans to expand contract…

New CDMO PMI BioPharma Launches Research Lab and Mfg Facilities
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PMI BioPharma Solutions (PMI Bio), a new contract development and manufacturing organization formed in January of 2018, has established research and manufacturing operations at multiple sites located in Nashville and…

Takeda Moves US Base to Boston
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Takeda plans to close its US headquarters in Deerfield, Illinois and move its functions to the Boston area. The move follows Takeda’s proposed $62-billion acquisition of Shire, announced in May…

Mylan, Fujifilm Receive EU Approval for Biosimilar of AbbVie’s Humira
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The European Commission (EC) has granted marketing authorization for Hulio (adalimumab), a biosimilar to AbbVie’s Humira (adalimumab), an anti-inflammatory drug, for all indications, to Mylan and Fujifilm Kyowa Kirin Biologics…