Amylyx Pulls ALS Drug, Reduces Workforce

Posted by ISPE Boston
On April 11, 2024

Amylyx Pharmaceuticals has started a process with the FDA and Health Canada to voluntarily discontinue the marketing authorizations for its ALS drug and immediately remove the product from the market in both the U.S. and Canada. The drug is sold under the name Relyvrio in the U.S.and is also known as AMX0035. The decision is […]

PureTech Launches Seaport Therapeutics with $100 Million

Posted by ISPE Boston
On April 11, 2024

Clinical-stage biotherapeutics company PureTech Health has launched Seaport Therapeutics with $100 million in an oversubscribed Series A financing. Seaport will focus on development of a pipeline of neuropsychiatric medicines created and initially developed at PureTech. Following the Series A financing, PureTech will hold equity ownership in Seaport of 61.5 percent on a diluted basis. Seaport […]

Around the World in One Night!

Posted by Eric Felz
On April 5, 2024

The inaugural “Around the World Gala” hosted by the ISPE Boston Area Chapter was a resounding success, surpassing all expectations and truly embodying its tagline: Celebrate, Unite, Inspire. This elegant soirée brought to fruition through the collaborative efforts of the WIP and EDEI Committees, offered attendees an unforgettable experience filled with cultural richness and camaraderie. […]

Chapter Member Anniversaries: April 2024

Posted by ISPE Boston
On April 4, 2024

Please congratulate the following members celebrating milestone anniversaries in April 2024. Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Ryan Ark, Alnylam Pharmaceuticals Rick E. Cavalli, NECI Donald Cole, Hart Passivation Services, Inc. Gregg A. Conboy, Erland Construction, Inc. Daniel D. Crosby, Bristol Myers Squibb Paul D. […]

Welcome New Members March 2024

Posted by ISPE Boston
On April 4, 2024

We would like to introduce the Members who joined ISPE in March 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 […]

Moderna Gets $750 Million to Develop Flu Vaccine

Posted by ISPE Boston
On April 3, 2024

Moderna recently entered into a development and commercialization funding agreement with Blackstone Life Sciences to advance the company’s flu program. As part of the agreement, Blackstone will fund up to $750 million with a return based on cumulative commercial milestones and low-single digit royalties. Influenza leads to 3-5 million severe cases of flu and 290,000-650,000 […]

Stoke Therapeutics to Gross $125M from Sale of Shares

Posted by ISPE Boston
On April 3, 2024

Bedford biotech Stoke Therapeutics expects gross proceeds from its public offering of shares to reach $125 million. The offering is expected to close on or about April 2, 2024. Stoke is focused on addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines. Using its proprietary approach, the company is developing antisense […]

Transformative Impact: My Journey with ISPE from Aspiring Student to Emerging Professional

Posted by Attrayee Chakraborty
On March 25, 2024

Joining ISPE has changed my life. I still remember when I was checking out ISPE Boston in August 2022 as an aspiring student in regulatory affairs. Upon my arrival in the US, I joined ISPE in October 2022, marking the beginning of an extraordinary journey. My first event was at a EDEI event, where after […]

Orchard Therapeutics Sets $4.25M Price for Gene Therapy

Posted by ISPE Boston
On March 21, 2024

Orchard Therapeutics has received FDA approval for gene therapy Lenmeldy for the treatment of children with early-onset MLD, a rare and life-threatening inherited disease of the body’s metabolic system caused by a genetic mutation. The one-time, potentially life-saving treatment will carry a list price of $4.25 million, making the treatment the most-expensive ever approved according […]

AstraZeneca Adds RCs for Cancer with Fusion Buy

Posted by ISPE Boston
On March 21, 2024

AstraZeneca is buying Canadian clinical-stage biopharma Fusion Pharmaceuticals in a deal worth up to $2.4 billion. The acquisition of Fusion, a developer of radioconjugates (RCs) for cancer treatment, marks a major step forward in AstraZeneca’s goal to replace traditional cancer treatment regimens like chemotherapy and radiotherapy with more targeted treatments. RCs have emerged as a […]

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