Clinical Intelligence

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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The CenterWatch Weekly, August 22, 2016

Monday, August 22, 2016

As necessity for real-world evidence rises, PPD acquires of Evidera

Pharmaceutical Product Development (PPD) has agreed to buy Evidera, a Maryland-based company that provides evidence-based solutions for the healthcare industry, as demand rises for research that shows the effectiveness and value of new medicines in real world settings.

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FDA grants Soligenix’s Dusquetide Orphan designation for Macrophage Activation Syndrome

Friday, August 19, 2016

Soligenix, a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, has announced that the Office of Orphan Products Development of the FDA has granted Orphan drug designation to the active ingredient dusquetide for treatment of macrophage activation syndrome (MAS). Dusquetide has previously received Orphan drug designation for the treatment of acute radiation syndrome (ARS). 

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Endo drops abuse deterrent labeling for OPANA ER

Monday, August 15, 2016

Endo International has announced that, based on an August 11, 2016 discussion with the FDA, the company has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for OPANA ER without prejudice to re-filing. The company plans to continue collecting and analyzing epidemiological data relating to OPANA ER. Endo’s financial projections for 2016 did not assume approval of the sNDA.

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