Biogen Wins Accelerated Approval for ALS Drug

Posted by ISPE Boston
On May 4, 2023

The FDA has granted Biogen conditional approval for antisense oligonucleotide Qalsody (tofersen) for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the SOD1 (superoxide dismutase 1) gene, producing a rare, hereditary form of the disease. Qalsody is the first approved treatment to target a genetic cause of ALS. Tofersen was […]

Emerging Leaders’ Coolest Event of the Month – The Puttshack Experience

Posted by ISPE Boston
On May 2, 2023

On Tuesday, April 25th the Emerging Leaders organized the coolest event, by kicking-off a competition between members with tech-infused mini golf at Puttshack Boston. We had a wonderful turnout at this April social – The Puttshack Experience Social! Many members showed up ready to play and show their mini golf skills while meeting and network […]

Chapter Member Anniversaries: May 2023

Posted by ISPE Boston
On May 1, 2023

Please congratulate the following members celebrating milestone anniversaries in May 2023. Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Karen Conte, Pfizer Timothy Crowley, Sentrol, Inc. Daniel Duffy, Sanofi John Evers, Lantheus Medical Imaging Joshua Froimson, AbbVie Bioresearch Center Robert Houtz, Waters Corporation Robert Huscher, Steris Doyle […]

Welcome New Members April 2023!

Posted by ISPE Boston
On May 1, 2023

We would like to introduce the Members who joined ISPE in April 2023, 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 […]

Spring Membership Drive

Posted by ISPE Boston
On April 25, 2023

ISPE Boston’s Spring Membership Drive begins on Monday, May 1st, 2023 and runs through Wednesday, May 31st, 2023. Be one of the first twenty-five (25) people to sign up for a Boston-Area-Chapter membership, and you’ll receive an ISPE Beach Towel AND an ISPE Stainless Steel Wine Mug! This special offer includes student memberships, so make […]

Moderna and Merck Report Progress on Cancer Vaccine

Posted by ISPE Boston
On April 20, 2023

Moderna and Merck have announced positive results from the Phase 2b trial evaluating Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda in patients with high-risk melanoma. The study demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival and reduced the risk of recurrence or death by 44% compared with Keytruda alone. mRNA-4157 (V940) […]

Takeda Announces Positive Trial Results for TYK2 Inhibitor

Posted by ISPE Boston
On April 13, 2023

Takeda has announced positive results from a Phase 2b clinical trial of a tyrosine kinase 2 (TYK2) inhibitor in patients with moderate-to-severe plaque psoriasis, meeting its primary and secondary endpoints compared to placebo. “We are confident that we can execute a comprehensive development program and deliver a potential best-in-class therapy for patients, given Takeda’s strong background […]

Novartis Phase 3 Trial of Kisqali Shows Benefit in Early Breast Cancer

Posted by ISPE Boston
On April 13, 2023

Novartis has announced positive topline results from an interim analysis of a Phase 3 trial evaluating Kisqali (ribociclib) plus endocrine therapy (ET) in patients with a form of early breast cancer (EBC) at risk of recurrence. Kisqali has already been approved in 99 countries worldwide, including by the FDA and the European Commission, for treatment. of […]

Upcoming Webinar: Uses of Data Analytics in Biotech April 24, 5pm

Posted by ISPE Boston
On April 10, 2023

Clark University, with leaders from Bio-AI Health, Portsmouth Harbor BioPharma Consultants, ISPE, and Clark University School of Professional Studies are presenting a webinar on April 24th, 5pm ET to discuss the importance of Data Analytics and Artificial Intelligence in biopharmaceutical product development; the education required to enter the field, including a summary of the current […]

Karuna Announces Positive Trial Results for Schizophrenia Drug, Raises $460 Million via Stock Offering

Posted by ISPE Boston
On April 7, 2023

Boston-based Karuna Therapeutics, a clinical-stage biopharma with a focus on psychiatric and neurological conditions, has announced positive topline results from its Phase 3 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT (xanomeline-trospium) in adults with schizophrenia. The trial met its primary endpoint, with KarXT demonstrating a statistically significant and clinically […]

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