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Sen. Amy Klobuchar (D-Minn.) wrote to the CEOs of Novo Nordisk, Sanofi and Eli Lilly asking them to justify recent steep price hikes for insulin medication. The cost of insulin has increased more than threefold in the last decade, which, Klobuchar said, is likely due in large part to the relative lack of competition, while insulin manufacturers have failed to document a corresponding increase in production costs. Read More
The European Medicines Agency is putting off plans for GMP inspections in the U.S. when possible, an EMA spokesperson confirmed this week, in anticipation of the November launch of a mutual agreement between the EU and U.S. Read More
During a January 2017 inspection, Shandong Analysis and Test Center was found to have failed to ensure its API testing procedures were scientifically sound. Read More
The lawsuit alleged that Allergan representatives targeted doctors around the country and pushed Restasis and other drugs for off-label uses. Read More
The update to EMA’s 2007 guidance would discuss how to assess results aimed at showing a vaccine is as good as or better than a product already on the market. Read More
Patients are 266 percent more likely to not pick up brand-name medications after requesting them at a pharmacy, compared to generic prescriptions, according to the Association for Accessible Medicine’s annual report. Read More
A new class-action lawsuit from a terminal blood cancer patient claims that Celgene abused consumer safety regulations to monopolize cancer drugs. Read More
A federal jury awarded GlaxoSmithKline $235 million in a suit against Teva, saying the generics manufacturer infringed on GSK’s patent for the cardiovascular drug Coreg when Teva marketed its generic for chronic heart failure as well as high blood pressure. Read More