Alkermes Drug for Depression Gets a Second Chance from the FDA

Posted by ISPE Boston
On May 2, 2018

Alkermes has announced that the FDA has accepted for review its New Drug Application (NDA) for ALKS 5461, a drug for the treatment of major depressive disorder (MDD) in patients who meet certain criteria. FDA’s acceptance of the NDA came just two weeks after the agency issued a Refusal to File letter and follows discussions […]

XaaS Data Integrity Gurus Draw Chapter Members to WPI

Posted by Chris Campia
On April 26, 2018

As technological advances increase, the need for companies to comply with robust data integrity practices becomes more and more important. Chapter members gathered at WPI on April 12 for an educational program on data integrity which took place in conjunction with the Student Poster Competition. As a special bonus, attendees were able to view the […]

Try Your Hand at Regenerative Manufacturing May 18-19

Posted by Russell Carr
On April 25, 2018

Several Chapter members attended the NH High Tech Council event about Biotech/Medtech in Manchester, NH on April 5. Dean Kamen and others from the Advanced Regenerative Manufacturing Institute (ARMI) presented their vision of the future of tissue engineering. ARMI is charged with bringing tissue engineered products to market and is involved with product development, manufacturing […]

Learn About Genomics and Epigenetics & Save!

Posted by ISPE Boston
On April 25, 2018

No current medical development raises so many opportunities – ranging from cancer treatment, to degenerative disease, to aging itself. To learn more, join the Medical Development Group (MDG) on Monday, April 30 at Regis College Fine Arts Center in Weston, MA for their program “Genomics and epi-Genetics – Impact on Developments in Medicine and Society.” […]

Reap Rewards as a Chapter Volunteer

Posted by ISPE Boston
On April 24, 2018

We’ve just made it easier for members to join the team of Boston Area Chapter volunteers. Becoming a volunteer enables you to build relationships with other Chapter members and helps you grow personally and professionally. All while helping the Chapter accomplish its goals. And to make it even easier for you to contribute your talents […]

Chapter Members: Local ISPE Training at a Discount Just for You

Posted by ISPE Boston
On April 19, 2018

Take advantage of a rare opportunity – four full days of ISPE biopharma training in the Boston area May 7-10 plus a 20 percent discount for members of the Boston Area Chapter! Enjoy specialized, in-depth classroom trainings from leading industry experts in seven critical areas: Biopharmaceutical Manufacturing Facility Design and Processes, GAMP® 5 Basic Principles […]

The Best and Brightest Shine at the Student Poster Competition

Posted by Brian Hagopian
On April 18, 2018

This year’s Student Poster Competition featured a record number of entries with students from Framingham State, Northeastern, University of New Hampshire, UMass Amherst and MCPHS University participating in graduate and undergraduate categories. Winning presenters receive an all expenses paid trip to the ISPE Annual Meeting in November to compete in the International Student Poster Competition […]

BioReady Communities Well-Positioned to Support Life Sciences Growth in MA

Posted by ISPE Boston
On April 16, 2018

The BioReady Community designation from Massachusetts Biotechnology Council (MassBio) signifies that a municipality has biotech and life sciences friendly zoning, has a streamlined permitting process, and has robust infrastructure in place. The designation serves to showcase Massachusetts communities that are ready to host new life sciences research and manufacturing facilities. There are currently 84 BioReady […]

Novartis to Acquire AveXis, Expand Position in Gene Therapy

Posted by ISPE Boston
On April 16, 2018

Novartis has announced that it has entered into an agreement to acquire the Illinois-based clinical stage gene therapy company AveXis, Inc. for $218 per share or a total of $8.7 billion in cash. AveXis has several clinical studies in progress for the treatment of SMA, an inherited neurodegenerative disease caused by a defect in a […]

Amgen’s Next-Generation Biomanufacturing Plant Heads for Rhode Island

Posted by ISPE Boston
On April 10, 2018

Amgen today announced plans to build a new state-of-the-art next-generation biomanufacturing plant at its campus in West Greenwich, R.I. The new plant, the first of its kind in the U.S., will employ Amgen’s proven next-generation biomanufacturing capabilities and manufacture products for the U.S. and global markets. A next-generation biomanufacturing plant incorporates multiple innovative technologies into […]

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