Clinical Intelligence

Takeda launches global observational study in multiple myeloma

Wednesday, September 7, 2016

Takeda Pharmaceutical has announced that its global non-interventional, observational multiple myeloma study is now enrolling patients. Titled INSIGHT-MM, the study aims to enroll 5,000 patients over three years with a goal of following each patient for a minimum of five years in an effort to track patterns in disease presentation, patient characteristics, treatment and outcomes and thereby enhance the understanding of real world experience of patients with multiple myeloma.

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Mylan to launch generic EpiPen for $300

Tuesday, August 30, 2016

Mylan has announced that its U.S. subsidiary will launch the first generic to EpiPen Auto-Injector (epinephrine injection, USP) at a list price of $300 per generic EpiPen two-pack carton, which represents a discount of more than 50% to the Mylan list price, or wholesale acquisition cost (WAC), of the branded medicine. [Read More]

Inovio launches Zika vaccine trial to explore early signals

Monday, August 29, 2016

Inovio Pharmaceuticals has initiated a clinical study of its preventive Zika vaccine (GLS-5700) in 160 subjects in Puerto Rico, where the Zika virus outbreak has been declared a public health emergency. The CDC estimates Zika will infect more than 25% of the Puerto Rican population by year end, providing the potential for this study’s placebo control design to provide exploratory signals of vaccine efficacy.

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Evofem enrolls first patient in Amphora Gel vaginal Ph trial

Friday, August 26, 2016

Evofem, a biotechnology company focused on the development and commercialization of women’s health products, has announced that patient enrollment has begun in their clinical study that will evaluate the effect and duration of Evofem’s proprietary vaginal gel, Amphora for bacterial vaginosis (BV), on vaginal pH.

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Lilly, AstraZeneca receive FDA Fast Track for Alzheimer’s treatment AZD3293

Tuesday, August 23, 2016

Eli Lilly and AstraZeneca  have received FDA Fast Track designation for the development program in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in phase III clinical trials. The FDA’s Fast Track program is designed to expedite the development and review of new therapies to treat serious conditions and tackle key unmet medical needs.

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