United States

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.

[Read More]

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.

[Read More]

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.

[Read More]

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.

[Read More]

Aerie reports results of phase III trial of rhopressatm for glaucoma

Wednesday, November 2, 2016

Aerie Pharmaceuticals, a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of glaucoma and other diseases of the eye, has reported the successful 90-day topline efficacy results of its Rocket 4 phase III clinical trial of product candidate Rhopressa, a novel once-daily eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The Rocket 4 trial is designed to provide adequate six-month safety data for European regulatory filing purposes. Rocket 4 is not necessary for new drug application (NDA) filing purposes.

[Read More]