Acceleron Announces Positive Trial Results

Posted by ISPE Boston
On February 5, 2020

Acceleron Pharma has announced that its Phase 2 trial of sotatercept met its primary and key secondary endpoints in patients with pulmonary arterial hypertension (PAH). “We’re thrilled to report such positive topline results…” said Habib Dable, President and Chief Executive Officer of Acceleron. “PAH is a debilitating disease of high unmet medical need, so we’re […]

Student Career Workshop Wins High Praise from Attendees

Posted by Rob Crory
On February 4, 2020

“I’ve never received such useful advice about my career before. I came to the event last year but I still learned so many new ideas and tips this year,” says Megha Shah, a Chemical Engineering Student from UMass Amherst. Megha was one of the many students and young professionals who attended the Student Career Workshop […]

GAMP Forum Attracts a Crowd to Cambridge

Posted by Heather Longden
On January 29, 2020

The GAMP Forum attracted a great turnout on January 16, with almost 100 attendees gathering with the Boston Area Chapter for a half-day filled with new information on a popular topic. Happily, the event drew many not already members of ISPE whom we hope are encouraged to join the Boston Area Chapter and the GAMP […]

GAMP Forum: SaaS, AI/ML and BlockChain in Regulated Environments

Posted by Heather Longden
On January 29, 2020

At the recent GAMP Forum sponsored by the ISPE Boston Area Chapter, multiple presenters from across the US, all active members of the ISPE GAMP Community of Practice (COP), met to discuss computer system validation (CSV) or Computer Software Assurance (CSA). First, a bit of background: As the regulated medical device and drug industry struggles […]

Scholarship Winners Ensure the Future of Pharma

Posted by ISPE Boston
On January 22, 2020

Chemical engineering, biotechnology, bioengineering – these are just of few of the career choices represented by the latest winners of the Joel Goldenberg Memorial Scholarships awarded by the ISPE Boston Area Chapter Scholarship Foundation and made possible by donations from generous individuals and industry stakeholders. These latest awards bring the total awarded by the Chapter […]

Biogen to Buy Alzheimer’s Drug from Pfizer

Posted by ISPE Boston
On January 22, 2020

Biogen has announced an agreement to acquire a novel drug from Pfizer for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases including Alzheimer’s and Parkinson’s. The purchase of the drug, a CNS-penetrant small molecule inhibitor of casein kinase 1 (CK1), will include an upfront payment of $75 […]

Blueprint Medicines Wins First FDA Approval

Posted by ISPE Boston
On January 22, 2020

Blueprint Medicines, a Cambridge biotech focused on genomically defined cancers, rare diseases and cancer immunotherapy, has announced FDA approval for Ayvakit (avapritinib), its kinase inhibitor for the treatment of a genomically defined population of patients with gastrointestinal stromal tumor (GIST), a rare, sarcoma of the GI tract. “The full approval of Ayvakit…is an incredibly exciting […]

Sarepta & Roche Ink $1.1b Licensing Deal

Posted by ISPE Boston
On January 10, 2020

Sarepta Therapeutics and Roche have entered into a licensing agreement providing Roche exclusive commercial rights to SRP-9001, Sarepta’s investigational gene therapy for Duchenne muscular dystrophy (DMD), outside the United States. Under the agreement, Sarepta will receive $1.15 billion in an upfront payment and an equity investment; up to $1.7 billion in regulatory and sales milestones; […]

Ring Therapeutics to Use Novel Viruses to Deliver Gene Therapies

Posted by ISPE Boston
On January 10, 2020

Flagship Pioneering has launched Ring Therapeutics, an early-stage biotech developing first-in-class gene therapies using a new viral vector platform based on its groundbreaking work on the human commensal virome. Ring’s technology promises to address many of the limitations of current DNA and gene therapies, such as limited access to diverse tissues, inability to redose, risk […]

Chapter Member Anniversaries: January 2020

Posted by ISPE Boston
On January 3, 2020

Please congratulate the following members celebrating milestone anniversaries in January 2020. Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Daniel E. Baxter, Vertex Pharmaceuticals Incorporated Dr. Anthony C. Bevilacqua, Ph.D., Mettler-Toledo Thornton Inc Erik M. Caldwell, Northeast Water Svcs, Inc. Brian L. Clark, GMP Operations Consulting Andrew […]

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