United States

Epizyme receives Fast Track for Tazemetostat in B-cell lymphoma

Tuesday, November 29, 2016

Epizyme, a clinical-stage biopharmaceutical company creating novel epigenetic therapies, has announced advancements in the company’s clinical programs evaluating tazemetostat, its first-in-class EZH2 inhibitor. The FDA has granted tazemetostat Fast Track designation in patients with diffuse large B-cell lymphoma (DLBCL) with EZH2 activating mutations. Additionally, Epizyme is focusing its phase II registration-enabling study in adult patients with genetically-defined solid tumors on those cancers marked by loss of INI1, and has expanded enrollment in the epithelioid sarcoma cohort of the study based on encouraging early activity in this patient population.

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Steven G. Zylstra named Executive of the Year

Tuesday, November 29, 2016

The Arizona Technology Council’s President and CEO Steven G. Zylstra has been named the Arizona Society of Association Executives (AzSAE) Executive of the Year. The highest recognition given to a chief staff executive by the AzSAE, Zylstra is being recognized for his commitment to his association, its members, his civic and community affairs, and the affiliate associations and organizations he serves.

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Shire to establish rare disease innovation hub in Massachusetts

Wednesday, November 23, 2016

Shire will expand its operations in Cambridge, Massachusetts, establishing a rare disease innovation hub and increasing its footprint in the heart of Kendall Square. Shire and BioMed Realty have signed a lease for a 343,000-square-foot building at 500 Kendall Street. Shire’s lease begins in Q3, 2018, with occupancy anticipated for Q1, 2019.

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FDA approves Intrarosa for postmenopausal women experiencing pain during sex

Monday, November 21, 2016

The FDA has approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).

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MYnd Analytics, Carolina Partners to launch personalized mental health program

Monday, November 21, 2016

MYnd Analytics and Carolina Partners in Mental Healthcare are teaming up to provide personalized care to veterans and civilians seeking quality evidence based mental health care. Carolina Partners, a 25 clinic outpatient psychiatry group practice based in Durham, N.C., is the first non-governmental site to launch the SMART-MD protocol for Veterans. This randomized, double-blind, multi-site clinical study will enroll patients—including veterans, active service members and their families—with a primary diagnosis of depression. 

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FDA grants Fast Track Designation to E2609 for Alzheimer’s

Friday, November 18, 2016

Eisai announced has received FDA Fast Track designation for the development of E2609, a Beta-secretase Cleaving Enzyme (BACE) inhibitor currently being evaluated in phase III clinical trials for early Alzheimer’s disease. E2609 was discovered by Eisai and is being jointly developed by Eisai and Biogen as a potential Alzheimer’s disease (AD) modifying treatment.

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