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FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 15, 2016. "Emergent’s large-scale manufacturing facility, intended to increase the manufacturing capacity for

Ongoing quality control analysis has revealed that the stored drug product is no longer within the original specification. In discussion with the MHRA Clinical Trials Unit, and with

"Our investments reflect our ongoing commitment to growing our operational presence and export capacity in Canada," said Joseph C. Papa, chairman and chief executive officer. "Over the past

The initiation of a ND submission to the US Food and Drug Administration (FDA) is ahead of the company’s earlier unveiled schedule. The company’s NDA is a rolling

Sectoral Asset Management led the round, which included participants such as Novo A/S, Aisling Capital and Brace Pharma Capital. Existing investors Advent Life Sciences, Novartis Venture Fund, Sunstone

Eflornithine is a novel cytostatic agent, which is being developed to treat patients with recurrent anaplastic astrocytoma, a rare form of central nervous system cancer. The drug irreversibly

The acquired portfolio includes products that are being divested by Teva as a precondition to its closing of the acquisition of Allergan’s generics business. Acquisition Highlights Sagent has

The new partnership, ‘Arkin Bio-Ventures’ (51% Arkin Holdings and 49% Phoenix) aims to invest in companies that develop promising innovative pharmaceuticals in pre-clinical and more advanced stages, both

The partnership brings together Cantabio’s novel approach and the University of Antioquia’s research excellence on the role of oxidative stress in PD and other neurodegenerative diseases. Pharmaceutical chaperones