FDA Approves Eli Lilly’s Alzheimer’s Drug

Posted by ISPE Boston
On August 2, 2024

The FDA has approved Kisunla, Eli Lilly’s Alzheimer’s treatment for adults with early symptomatic Alzheimer’s disease (AD), which includes people with mild cognitive impairment as well as people with the mild dementia stage of AD, with confirmed amyloid pathology. Once-monthly Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when […]

BioInvestigate Challenge: Nurture the Next Generation of Biopharma Innovators

Posted by ISPE Boston
On July 18, 2024

Calling all biopharmaceutical industry leaders! Your expertise can shape the future of our field. The BioInvestigate Challenge invites you to mentor bright, ambitious students as they tackle real-world industry investigation challenges. As a mentor, you will: Guide teams through complex problem-solving scenarios Share your invaluable industry insights and experience Help cultivate innovative thinking in emerging […]

Celsius Acquired by AbbVie for $250 million

Posted by ISPE Boston
On July 17, 2024

AbbVie has announced the acquisition of privately held Cambridge biotech Celsius Therapeutics. Celsius is pioneering new therapies for patients with inflammatory disease. Celsius’ lead investigational asset is CEL383, a potential first-in-class anti-TREM1 antibody that has completed a Phase 1 clinical study for the treatment of inflammatory bowel disease (IBD). TREM1 has been identified as a key […]

Alnylam Reports Positive Results from Phase 3 Study

Posted by ISPE Boston
On July 17, 2024

RNAi therapeutics company Alnylam has announced positive topline results from its Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM), a rare heart condition that is both progressive and fatal. Transthyretin amyloidosis (ATTR) is an underdiagnosed, rapidly progressive, debilitating and fatal disease caused by […]

Sarepta Wins FDA Approval for Muscular Dystrophy Drug

Posted by ISPE Boston
On July 17, 2024

Sarepta Therapeutics has received FDA approval of an expansion to the labeled indication for Elevidys, a single-dose, adeno-associated virus (AAV)-based gene transfer therapy designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene […]

Another win for the Red Sox and for the ISPE Emerging Leaders Committee!

Posted by Tyler Haywood
On July 16, 2024

The 3rd annual Emerging Leaders Red Sox Game was another smashing success! Thank you to everyone who showed up to support the event, especially our generous sponsors BWT. It was great seeing some new and some familiar faces. ELC looks forward to putting on more fun and educational events. Go Sox!

Why a User Requirement Specification is more than just an Exercise

Posted by Howard Sneider
On July 8, 2024

Since the proliferation of the V model of Computer System Validation (CSV), The User Requirement Specification (URS) has been on a figurative roller coaster of public opinion and proper use. The URS was originally conceived to enable as-built performance testing of a design against specifications as part of the V-model. While it served a vital […]

Kicking off the Summer with the Annual Volunteer Appreciation Social

Posted by Katelyn Vallery
On July 8, 2024

The heat didn’t stop the ISPE Boston Area Chapter from having a great time at our Annual Volunteer Appreciation Social. Nice cold refreshments kept everyone happy while they got to relax and mingle at the River Bar in Somerville. A big thanks again to the amazing volunteers that make our chapter so successful year after […]

Chapter Member Anniversaries: July 2024

Posted by ISPE Boston
On July 3, 2024

Please congratulate the following members celebrating milestone anniversaries in July 2024. Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Oliver Bausch, Bausch Advanced Tech. James Blackwell, The Windshire Group, LLC Stephen Campbell, CRC Consulting LLC Christopher Gallagher, SPEC Shelly Henderson Troy LeBlanc, Takeda Pharmaceuticals Inc. Daniel Mathien, […]

Welcome New Members June 2024

Posted by ISPE Boston
On July 3, 2024

We would like to introduce the Members who joined ISPE in June 2024, welcome them to the Chapter, and encourage them (and all 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 the […]

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