Sage Therapeutics and Biogen Announce Positive Phase 2 Results

Posted by ISPE Boston
On April 15, 2021

Sage Therapeutics and Biogen have reported topline results from the Phase 2 KINETIC Study evaluating SAGE-324 in the treatment of people with essential tremor (ET). The study achieved its primary endpoint of a statistically significant reduction from baseline compared to placebo. “We are encouraged by the positive results of the KINETIC Study, which indicate that […]

EDEI Panelists Tie Diversity to Business Success

Posted by Eric Felz
On April 8, 2021

On February 24, the Chapter’s newly formed Ethnocultural Diversity, Equity, and Inclusion (EDEI) Committee held its kick-off event and panel discussion via Zoom webinar. This panel discussion covered how companies should be fostering a more diverse workforce and why diversity within a company makes good business sense. Our panel of speakers included: Dr. John Armendariz, […]

J&J Takes Over COVID Vaccine Manufacture at Emergent

Posted by ISPE Boston
On April 8, 2021

Johnson & Johnson has announced that it is assuming full responsibility regarding the manufacturing of drug substance for its COVID-19 vaccine at contract manufacturer Emergent BioSolutions Maryland facility. Specifically, J&J is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the company’s […]

Aveo Oncology Wins FDA Approval for Kidney Cancer Drug

Posted by ISPE Boston
On April 8, 2021

Aveo Oncology has announced FDA approval for Fotivda (tivozanib) for the treatment of adults with renal cell carcinoma (RCC) who meet certain treatment guidelines. Fotivda is a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) and was approved in August 2017 in the European Union and other EUSA countries. According to the American Cancer Society, renal cell […]

ElevateBio Scales Business Model with $525M Financing Round

Posted by ISPE Boston
On April 8, 2021

ElevateBio has raised $525 million in a Series C financing. According to its website, the company has created a business model addressing the most pressing challenges in the field of cell and gene therapy. Its suite of technologies includes gene editing, induced pluripotent stem cells, and protein, viral, and cellular engineering. With this financing, ElevateBio […]

Chapter Member Anniversaries: April 2021

Posted by ISPE Boston
On April 5, 2021

Please congratulate the following members celebrating milestone anniversaries in April 2021. Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Michael S. Cheney, Biogen Idec Donald Cole, Hart Passivation Services, Inc. Daniel D. Crosby, Bristol Myers Squibb James P. Grunwald, DPS Group Paul F. Herbert, Elektrofi Inc Donna […]

Welcome New Members March 2021!

Posted by ISPE Boston
On April 5, 2021

We would like to introduce the Members who joined ISPE in March 2021, welcome them to the Chapter and encourage them (and all of our members) to take advantage of the many professional development, networking and information resources available through ISPE. Fellow ISPE members are a terrific resource for help with everyday professional challenges. And […]

J & J Explains Quality Issue at Vaccine Manufacturing Partner

Posted by ISPE Boston
On April 1, 2021

On March 31, following reports in the New York Times and other media sources regarding coronavirus vaccine quality issues at its manufacturing partner Emergent BioSolutions, J & J released an official statement, excerpted below: Since January of 2020, Johnson & Johnson has been working directly with governments, health authorities and other companies to help end […]

Multiple Myeloma Drug from BMS and bluebird bio Wins FDA Approval

Posted by ISPE Boston
On April 1, 2021

Bristol Myers Squibb and Cambridge-based bluebird bio have announced FDA approval for Abecma, a personalized immune cell therapy for the treatment of certain patients with multiple myeloma. As an anti-BCMA CAR T cell therapy, Abecma recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of […]

“Pharmaceutical Quality – What’s New, What’s Next?” Webinar Provides Answers

Posted by Heather Longden
On March 31, 2021

On March 18, the Boston Area Chapter presented “Advancing Pharmaceutical Quality – What’s New, What’s Next?” via Zoom webinar. This panel discussion covered what’s new with ISPE’s Advancing Pharmaceutical Quality Program, FDA updates on quality metrics pilots and quality management maturity, insights on the latest pharmaceutical industry operational excellence benchmarks, and practical strategies for building […]

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