United States

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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Seattle Genetics receives FDA Breakthrough Designation for ADCETRIS

Friday, November 11, 2016

Seattle Genetics, a global biotechnology company, has announced that the FDA granted Breakthrough Therapy designation to ADCETRIS (brentuximab vedotin) for the treatment of patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) who require systemic therapy and have received one prior systemic therapy. MF and pcALCL are the most common subtypes of cutaneous T-cell lymphoma (CTCL), accounting for more than 75% of the disease.

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Bristol-Myers Squibb, Johns Hopkins collaborate on immuno-oncology research

Friday, November 11, 2016

Bristol-Myers Squibb has entered into a five-year research collaboration with the Johns Hopkins University. The collaboration is designed to identify mechanisms of response and resistance in patients whose cancer is being treated with checkpoint inhibitor-based immunotherapies, including Opdivo (nivolumab) monotherapy, or Opdivo in combination with Yervoy (ipilimumab) or other investigational immunotherapies.

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INC Research to manage Leukemia & Lymphoma Society umbrella trial

Friday, November 11, 2016

INC Research, a global phase I to IV CRO, has announced its involvement in The Leukemia & Lymphoma Society’s (LLS) recently-launched precision medicine Master Trial to treat acute myeloid leukemia (AML). The Beat AML Master Trial is breaking ground in a number of areas, including the first time a nonprofit organization is working with multiple biotech and pharma sponsors and other key collaborators to professionally operationalize a study. The trial will provide principal investigators and their patients consolidated access to test novel therapies matched to specific molecular aberrations in AML.

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