Summer Luau Celebrates the Chapter’s Volunteers Caribbean-Style

Posted by Dan Kenny
On July 11, 2017

With the summer in full swing and the weather perfect for an outing, the Chapter hosted a Caribbean-style luau for the annual Summer Social at Squantum Yacht Club in Quincy, MA on June 28th. The venue has proven to be a wonderful and accommodating spot for this social and, judging by the attendance each year, […]

Cast Your Vote for the New Board of Directors and Assure the Future of Our Chapter…

Posted by John Spohn
On July 6, 2017

The ballots to elect the Chapter’s next Board of Directors are being distributed as I write this post. Most will go electronically and the others have already been put in the mail. Please support the Chapter and show your connection by taking the few moments needed to fill out and return your ballot. On the […]

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, […]

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