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Pharmacy benefit manager Express Scripts is firing back at Anthem’s $15 billion lawsuit that accuses the PBM of breaching good faith negotiation requirements. Read More
The FDA has a slate of new recommendations companies should follow when submitting a comparability protocol assessing changes to the chemistry, manufacturing or controls of a drug or biologic after the agency has approved its production process. Read More
The list of Chinese pharmaceutical companies in the FDA’s crosshairs keeps on growing, with the agency hitting two drugmakers for GMP violations and another for refusing an inspection. Read More
A second FDA inspection of niche drugmaker Sri Krishna in almost 10 years has turned up a bevy of complaints regarding the company’s quality control systems and the accuracy of its data. Read More