Drug Industry Daily

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Pharma lobbyists managed to stave off price controls for Medicare Part D, and imports of cheaper drugs from Canada, in 2009 healthcare reform talks with White House officials, a congressional investigation finds.

The European Medicines Agency (EMA) has updated its draft guideline on venous thromboembolism (VTE) products, adding new definitions for bleeding events, and secondary endpoints to consider for clinical trials.

Pfizer has agreed to pull a 60-second direct-to-consumer (DTC) TV ad promoting a pair of drug-device combination products for severe allergic reactions after the FDA flagged it for overstating efficacy.

Irish drugmaker Alkermes is dropping development of constipation candidate ALKS 37 after the drug failed to meet pre-specified efficacy standards in Phase IIb trials.

The FDA has called out Vertex Pharmaceuticals for a promotional story on hepatitis C drug Incivek, saying it “misleadingly implies” that patients who do not respond to treatment with pegylated-interferon and ribavirin combination therapy will respond to Incivek combination therapy.