United States

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.

[Read More]

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). 

[Read More]

Allergan to expand in New Jersey, to create 300 jobs

Tuesday, August 16, 2016

The Board of the New Jersey Economic Development Authority (EDA) has approved Grow New Jersey (Grow NJ) tax credits to encourage the global pharmaceutical company Allergan, the U.S. subsidiary of Ireland-based Allergan, to remain in New Jersey and combine four existing company locations into a 431,495-square-foot facility in Madison. 

[Read More]

UnDx Consortium to focus on precision medicine

Tuesday, August 16, 2016

UnDx Consortium has launched. This organization brings together five precision medicine technology providers and experts from medical centers and universities across the country to collaborate in an effort to produce new hypotheses for a set of six patients struggling with undiagnosed diseases. UnDx Consortium will explore results of cutting-edge tests analyzing samples from these patients and their families.

[Read More]

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.

[Read More]