FDA Outlines Plans To Modernize Inspections for Sterile Injectable Drugs
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The US Food and Drug Administration (FDA) plans to take new steps to modernize its inspections program with a new way of assessing, recording, and reporting the data from surveillance…

Novartis’ Sandoz Recalls Losartan Product in the US Due to Impurity in API
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Sandoz, the generics arm of Novartis, is voluntarily recalling in the US one lot of losartan potassium hydrochlorothiazide tablets (USP 100 mg/25 mg), an anti-hypertension drug, to the consumer level.…

AstraZeneca To Divest US Rights to Respiratory Drug Synagis for $1.5 Billion
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AstraZeneca has agreed to sell its US rights to Synagis (palivizumab), a drug for preventing lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV), for $1.5 billion to…

Takeda Sets Date for Shareholder Vote on $62-Billion Acquisition of Shire
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Takeda Pharmaceutical Company plans to hold a shareholder meeting on December 5, 2018 to vote on matters relating to its proposed $62-billion acquisition of Shire. Takeda and Shire came to…

Pfizer 3Q Results Impacted by Supply Issues of Some Sterile Injectable Drugs
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As part of its third-quarter earnings, Pfizer reported lower-than-anticipated revenues from its Essential Health business segment primarily due to continued legacy Hospira sterile injectable pharmaceuticals (SIP) product shortages in the…

Hikma Pharmaceuticals To Acquire Injectable Manufacturing Company in Vietnam
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Hikma Pharmaceuticals, an Amman, Jordan-based pharmaceutical company, has agreed to acquire Medlac Pharma Italy Co. (Medlac), an injectable manufacturing company in Hoa Lac Hi-Tech Park, Vietnam. The acquisition includes an…

Sanofi, Denali Therapeutics Partner in $1-Billion Pact for Neuroscience Drugs
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Sanofi and Denali Therapeutics, a San Francisco, California-headquartered biopharmaceutical company developing drugs for treating neurodegenerative diseases, have partnered in a deal worth up to $1 billion ($125 million upfront) to…

WuXi Biologics, Recro Gainesville Expand
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A roundup of the latest news from suppliers, contract development and manufacturing organizations and contract manufacturing organizations, featuring WuXi Biologics and Recro Gainesville. Biologics Manufacturing  WuXi Biologics Begins Construction of…

BI Completes $228-Million Expansion of US Biomanufacturing Facility
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Boehringer Ingelheim (BI) has completed an expansion of its biomanufacturing facility in Fremont, California. With a two-year investment totaling EUR 200 million ($228 million), BI increasing its worldwide bioreactor capacity…

ScieGen Recalls Sartan Product Due to Impurity in API
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ScieGen Pharmaceuticals, a Hauppauge, New York-based generic pharmaceutical company, is voluntarily recalling in the US lots of its irbesartan tablets (USP 75 mg, 150 mg, and 300 mg), an anti-hypertension…