Monthly Archives: June 2017

FDA Update: Agency Takes Action to Eliminate Orphan Drug Backlog

By | June 29, 2017

The FDA has unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to… Read More »

FDA Update: Agency Takes New Steps to Encourage Development of Generics

By | June 29, 2017

The FDA is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where… Read More »

Syntimmune Lands $50 Million for Autoimmune Drug Development

By | June 27, 2017

Waltham-based Syntimmune, a clinical-stage biotechnology company focused on FcRn biology, has announced a $50 million Series B financing led by Apple Tree Partners, which has committed $48 million to the round, with additional participation from other existing investors. The proceeds will further advance Syntimmune’s clinical development program, which includes two ongoing Phase 1b/2a clinical trials… Read More »

What Do Brewing, Brettanomyces and Biotech Have in Common?

By | June 19, 2017

The ISPE Boston Area Chapter kicked off the summer season with a standing-room-only event, “Brewing, Brettanomyces, and Biotech,” at Springdale Barrel Room by Jack’s Abby in Framingham.  This sold-out event was met with great anticipation and attendees did not leave disappointed.  The evening opened with a lively networking session with beer, food and great company. … Read More »

What Do BMWs and Validation Have in Common? Engi•dati•ty Assurance!

By | June 6, 2017

On May 17, the ISPE Boston Area Chapter joined the PDA New England Chapter for a combined ISPE/PDA dinner event under the banner “Validation: The Bridge Between Engineering & Quality Assurance” helmed by two superb presenters: Sylvan Poeckh of Masy BioServices and Paul Stanovich of Process Design Solutions. This topic was selected because effective validation… Read More »