Bristol-Myers Squibb has agreed to sell its global diabetes business that was part of its collaboration with AstraZeneca for $2.7 billion with potential regulatory- and sales-based milestone payments of up to $1.4 billion and will make royalty payments based on net sales through 2025.
GlaxoSmithKline (GSK) will invest £200 million ($327 million) to expand its manufacturing facilities in Ware, Hertfordshire and Worthing, Sussex in the United Kingdom and establish a new manufacturing innovation facility.
FDA has issued a Warning Letter to Novartis for cGMP violations at its manufacturing facility for finished pharmaceuticals in Unterach, Austria. The site became part of Sandoz and Novartis through the acquisition of EBEWE Pharma in 2009.
Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to outline the agency’s case for supporting the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V.