FDA Update: Agency Takes Action to Eliminate Orphan Drug Backlog

Posted by Janet Tice
On 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 […]

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

Posted by Janet Tice
On 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 […]

Syntimmune Lands $50 Million for Autoimmune Drug Development

Posted by ispeblog
On 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 […]

Am I a Young Professional?

Posted by mdegirolamo
On June 27, 2017

We use the term “Young Professional” often at the Boston Area Chapter and you may be wondering what that really means. The official ISPE definition is anyone with ten years or less in the biotech/pharmaceutical industry. This means you can be a traditional student just graduating, a seasoned professional who decided to make a career […]

Posted by ispeblog
On June 20, 2017

Governor Baker will fly to California today to take part in the 2017 International BIO Conference. This follows on the heels of his proposal for a $500 million, 5-year extension of the life sciences initiative put in place by his predecessor in 2008. “BIO is a big opportunity for us to talk about the great […]

Posted by ispeblog
On June 20, 2017

Governor Charlie Baker’s proposed $500 million extension of the life sciences initiative put in place by his predecessor in 2008 will put a greater emphasis on workforce building to support industries that have taken root in Massachusetts. On Monday, Baker put forward a plan to spend heavily over the next five years on capital grants […]

What Do Brewing, Brettanomyces and Biotech Have in Common?

Posted by Eric Felz
On 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. […]

Biogen Drug Approved in EU as First Treatment for Spinal Muscular Atrophy

Posted by Janet Tice
On June 13, 2017

The European Commission (EC) has granted a marketing authorization for Biogen drug Spinraza (nusinersen) for the treatment of 5q spinal muscular atrophy (SMA). 5q SMA is the most common form of the disease and represents approximately 95 percent of all SMA cases. Spinraza is the first approved treatment in the European Union (EU) for SMA, […]

Posted by Chris Blackwell
On June 6, 2017

The local Chapters of ISPE and PDA joined forces on May 17th for a dinner program at the Hilton in Woburn. About 150 attendees turned out to wine, dine, network and learn about “Validation: The Bridge between Engineering & Quality Assurance” from invited speakers Sylvan Poeckh of Masy BioServices and Paul Stanovich of Process […]

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

Posted by Howard Sneider
On 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 […]

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