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Blog

Amgen’s Humira Biosimilar Moves Forward in Europe Amid Patent Fight with Abbvie

  • Posted by jwillard
  • On February 6, 2017
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing of ABP 501, a biosimilar for Abbvie’s Humira (adalimumab). The committee recommended approval for all available indications, including moderate-to-severe rheumatoid arthritis, chronic plaque psoriasis, Crohn’s disease and ulcerative colitis. ABP 501 is the first Humira […]
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Takeda to Acquire ARIAD Pharmaceuticals

  • Posted by ispeblog
  • On February 5, 2017
Takeda Pharmaceuticals has announced it will acquire all of the outstanding shares in ARIAD for $24.00 per share in cash, for a total value of approximately $5.2 billion. The transaction is expected to close by the end of February 2017. The acquisition of Cambridge-based ARIAD adds new investigational oncology products to Takeda’s pipeline, including Brigatinib […]
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Student Career Workshop: “Best Session I’ve Ever Attended!”

  • Posted by Brian Hagopian
  • On February 3, 2017
Comments ranged from “spectacular” to “best session I’ve ever attended” as the Chapter’s Annual Student Career Workshop wrapped up on Saturday, January 28 at Northeastern’s Raytheon Amphitheater. The full-day event was extremely well attended, making this – our fifth Career Workshop – the biggest to date.  Attendees gained valuable guidance, advice, and tips from 15 […]
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Pharmaceutical Water and Steam: Important Updates on the State-of-the-Art

  • Posted by Brian Hagopian
  • On February 3, 2017
The pharma and biotech industries spend millions of dollars annually in costly investigations into alert, action, and out of specification excursions related to the critical utilities of water and steam. These expenditures could be greatly minimized if the issues and challenges related to sampling were clearly understood. To address this knowledge gap, ISPE has introduced […]
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All Work, No Play? No Way! And We Have the Photos to Prove It!

  • Posted by Dan Kenny
  • On February 2, 2017
Last fall may be a distant memory – but these photos from our Oktoberfest social are too good to bury in the Chapter’s archives. So imagine yourself dressed in lederhosen, surrounded by friends and colleagues on a clear and chilly October evening at the Harpoon Brewery in South Boston.  Now hoist a pint, enjoy a […]
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Industry Leaders Discuss “Quality by Design” at Chapter’s Regulatory Symposium

  • Posted by mbraatz
  • On February 2, 2017
Industry leaders Bert Frohlich, Director of Strategy and Technology Lifecycle, Shire, and Amy Lachapelle, Lead Consultant & Founder, QbD Strategies, presented “Quality by Design” as part of the Chapter’s recent Regulatory Symposium held at Northeastern University. Well known in the regulatory field with a combined 38+ years of experience in biopharmaceutical manufacturing, the speakers presented […]
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Congratulations to Our Scholarship Winners!

  • Posted by Janet Tice
  • On February 1, 2017
The ISPE Boston Area Chapter has proudly awarded $12,400 to the following area students as part of the Chapter’s Joel Goldenberg Memorial Scholarship Program, bringing the total awarded in 2016 to $24,950. The Scholarship Program has been named in honor of Joel Goldenberg, a Past President of the Boston Area Chapter whose wish was to […]
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