FDA Recommends Approval of Sandoz’s Biosimilar Drug, a First

By: David Fazzolare On January 5, 2015, the US Food and Drug Administration’s (“FDA’s”) Oncologic Drugs Advisory Committee (the “Committee”) announced its recommendation that the FDA approve Sandoz Inc.’s application to market Zarxio® (EP2006), a biosimilar version of Amgen, Inc.’s Neupogen® drug.  The Committee explained its recommendation in a 62-page, publicly-issued briefing document.  Zarxio® is the …

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Federal Circuit in Sandoz v. Amgen Upholds District Court Ruling on Standing Requirements in Biosimilars Cases

By: David A. Fazzolare The recent back and forth between Amgen and Sandoz took another dramatic turn on December 5, 2014, when the Federal Circuit affirmed the district court’s dismissal of Sandoz’s declaratory judgment lawsuit against Amgen because Sandoz’s alleged injury did “not meet the requirements of immediacy and reality” necessary for standing. Regarding immediacy, …

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BBK Worldwide raises $3M, eyes acquisitions

MBBP client BBK Worldwide has raised $3 million from a private, undisclosed investor and its two founders. The consultancy specializes in patient recruitment for the clinical R&D segments of the pharmaceutical, biotechnology, and medical device industries. BBK moved from Newton to a new 15,000-square foot space in Needham earlier this year and has plans to grow …

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MBBP Attorney Stanley Chalvire to Speak at MDG Boston Forum

Medical Development Group (MDG), an organization for professionals in the medical device industry, is hosting an upcoming forum event entitled "Intellectual Property Approaches to Safeguard Value". MBBP IP and Licensing Attorney Stanley F. Chalvire will serve as one of the speakers of this forum event, which will generally be directed to intellectual property strategies for creating and preserving value of medical …

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MBBP’s Joanna Brougher 2014 National Law Journal Rising Star

 MBBP’s Joanna Brougher was selected for the 2014 National Law Journal's list of Boston's Rising Stars. The National Law Journal Rising Stars program recognizes the region's 40 most promising lawyers age 40 and under.  Joanna graduated from the University of Rochester with a B.S. in Microbiology, a B.A. in German, and a masters in public health. …

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