Jan. 16, 2019

Vol. 16 No. 11

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Novartis’ Crizalizumab Earns Breakthrough Designation

Novartis expects to file an NDA for the drug in the first half of 2019. Read More

Gottlieb Says User Fees Will Pay for Post-Market Surveillance Amid Shutdown

FDA activities that most directly impact safety will continue “to the best of our abilities, subject to the legal and financial limitations of the current circumstances,” Gottlieb said. Read More

FDA Warns Akorn Over Conditions at Sterile Drug Facility

The agency said the facility “did not provide a sufficient evaluation of all batches produced under inadequate conditions.” Read More

NICE Finalizes Recommendation for Bayer’s Stivarga

NHS currently treats advanced hepatocellular carcinoma with sorafenib or supportive care. Read More

California Governor Signs Executive Order Increasing State Powers to Negotiate Drug Prices

The state’s spending on prescription drugs has increased by about 20 percent per year since 2012. Read More