United States

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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Casebia Therapeutics establishes operations in Cambridge, Massachusetts

Tuesday, August 23, 2016

Casebia Therapeutics, the joint venture founded by Bayer and CRISPR Therapeutics, started its operations in Cambridge, Massachusetts. In December, 2015 Bayer and CRISPR Therapeutics agreed to create a joint venture to discover, develop and commercialize new breakthrough therapeutics to cure blood disorders, blindness and congenital heart disease. The two parties formally closed the transaction in the first quarter of 2016.

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