Biosimilar to Genentech’s Herceptin Wins FDA Approval

Posted by Janet Tice
On December 14, 2017

The FDA has approved Ogivri as a biosimilar to Herceptin for the treatment of patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene. Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the […]

FDA Approves First Short-Acting “Follow-On” Insulin Product

Posted by Janet Tice
On December 14, 2017

The FDA has granted approval to Sanofi-Aventis U.S. for Admelog, a short-acting insulin product. Admelog is the first short-acting insulin approved as a “follow-on” product and was submitted through the agency’s 505(b)(2) abbreviated approval pathway. A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is […]

Chapter Member Anniversaries: November 2017

Posted by ISPE Boston
On December 6, 2017

Please congratulate the following members celebrating milestone anniversaries in November 2017. Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Charles H. Brown, II, MS James R. Dube, Associate Director, Technology Transfer, Global Technical Services, Alexion Pharmaceuticals Thomas G. Larkin, Jr., Sr Project Engineering Manager, Amgen Inc Pasquale […]

Welcome New Members!

Posted by ISPE Boston
On December 6, 2017

We would like to introduce the members who joined ISPE in November 2017, welcome them to the Chapter and encourage them (and all of our members) to take advantage of the many professional development, networking and information resources available through ISPE. Fellow ISPE members are a terrific resource for help with everyday professional challenges. And […]

Foundation Medicine Wins FDA Approval for Breakthrough Cancer Test

Posted by ISPE Boston
On December 5, 2017

The FDA has approved the FoundationOne CDx (or F1CDx), a breakthrough cancer diagnostic test developed by Cambridge-based biotech Foundation Medicine. F1CDx detects gene mutations that may be found in any solid tumor. This information can be used by physicians to manage cancer patients. Moreover, it can be used as a companion diagnostic to identify patients […]

Chapter Members Learn “How to Deal with Difficult People”

Posted by Jimmy Hughes
On November 30, 2017

In contrast to the typical technically-focused educational events, the Boston Area Chapter’s November educational program – “How to Deal with Difficult People” presented by Amber Galou, Stephanie Fedak, and Bruce Sohmer – was a chance for attendees to shift their focus to “soft skills” that effect every aspect of life in the workplace. The speakers […]

Call for Presentations: Product Show 2018

Posted by ISPE Boston
On November 28, 2017

The ISPE Boston Area Chapter will hold its 27th Annual Product Show on September 26, 2018 at Gillette Stadium in Foxborough, MA. This notice is a call for presentations for a limited number of speaking opportunities. Our charter is to deliver valuable educational programs to our members and their guests, based on specific topics of interest […]

Stainless Steel and Single Use – More Similar than You Think…

Posted by Howard Sneider
On November 27, 2017

Over the past 20 years, the benefits and detriments of single use technologies for the manufacturing of biologics have been stated by proponents and detractors throughout the industry. Some issues are well defined (capital investment) while other topics lack clarity. This post will address a couple of often misunderstood facets of stainless steel and single […]

Fermentation Powers Biopharma…and Breweries

Posted by Brian Kennedy
On November 21, 2017

The fermentation process used in beer brewing is similar to the process used in the biopharmaceutical industry to produce therapeutic molecules. To see fermentation up close and personal, make sure you register for the November 30th brewery tour and networking social at Lord Hobo Brewery in Woburn. In a few words, fermentation is the process […]

Learning from the Experts at ISPE Annual Meeting

Posted by Jack Campion
On November 16, 2017

This year’s ISPE Annual Meeting in San Diego featured some exciting “Wow-they-really-did-that!” educational sessions, inspiring keynote speeches, and awards for the best and brightest, as well as meetings to advance the Society’s governance. Not to mention a healthy dose of great fun! About 85 Boston Area Chapter members traveled west for the four-day meeting in […]

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