Monthly Archives: December 2017

FDA and Spark Therapeutics Make History with Gene Therapy Approval

By | December 21, 2017

The FDA has approved Luxturna, an innovative one-time gene therapy treatment from Spark Therapeutics used to improve vision in patients with vision loss due to inherited retinal diseases (IRD). As the first adeno-associated viral (AAV) vector product approved for clinical use in the United States, Luxturna represents a historic landmark, not only in the field… Read More »

Single-Use vs. Stainless: Experts Weigh In…

By | December 15, 2017

By Bill Garvey and Howard Sneider: Single-use technology has exploded onto the scene in the last two decades to offer a practical alternative to costly stainless steel process systems. But will single-use systems render a mature and reliable technology eventually obsolete? This outcome is unlikely as a large group of ISPE members and other industry… Read More »

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

By | 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… Read More »

Chapter Member Anniversaries: November 2017

By | 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… Read More »

Welcome New Members!

By | 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… Read More »

Foundation Medicine Wins FDA Approval for Breakthrough Cancer Test

By | 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… Read More »