Patricia Van Arnum

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Articles

Bristol-Myers Squibb Sells Diabetes Business to AstraZeneca

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.

GSK Invests in UK Manufacturing

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 Issues Warning Letter to Novartis's Austrian Plant

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.

Drug Shortages Still in Focus

Drug shortages, particularly those for sterile injectable drugs, took center stage last year. In response, industry and the federal government, including FDA, took steps to address the problem.

GSK: A Rebuffed Suitor for the Moment

Last week Human Genome Sciences (HGS) rejected GlaxoSmithKline’s (GSK) unsolicited $2.59 billion bid for HGS or $13 per share.

GlaxoSmithKline Recalls Antihypertensive Drug Made at Novartis Facility

GlaxoSmithKline is recalling 394,230 bottles containing its antihypertensive drug DynaCirc CR (isradipine) controlled-release tablets, according to a Feb. 22, 2012, FDA enforcement report

Is the US Facing a Pharma Manufacturing Gap?

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.

Roche Ups the Stakes on Personalized Medicine

Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, holds much promise for the pharmaceutical industry.