United States

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]

Theranos to appeal CMS sanctions

Monday, August 29, 2016

Theranos, a health technology company, has filed a notice of intent to appeal the sanctions that the Centers for Medicare and Medicaid Services (CMS) imposed last month on the company’s Newark, California, lab.

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SAB Biotherapeutics wins BARDA MERS treatment contract

Monday, August 29, 2016

SAB Biotherapeutics, a clinical-stage biopharmaceutical development company, has been awarded a contract for up to $5.3 million by the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services (HHS). The funding will be used for advanced clinical manufacturing and testing for SAB’s novel antibody therapeutic (SAB-301) to treat MERS-CoV.

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Frenova Renal Research expands in the U.S.

Tuesday, August 23, 2016

Frenova Renal Research, a drug and medical device contract clinical development services provider dedicated to renal research, announced its opening of a new office location in downtown Durham, North Carolina, and the expansion of its U.S. field-based staff in New York, Illinois, North Carolina, Florida and Louisiana.

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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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