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chrishoward

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  • Intercept Pharmaceuticals: Serving Unmet Needs With Blockbuster Potential [View article]
    Good commentary Logribel. I would just add that I believe the FDA will be issuing guidance for NASH Ph.3's (for all co's) mid-year. Specifically, we will be looking to see to what degree they require CV/lipid outcomes as part of the pivotal trials, or subsequent LTE trials.
    Also, just on GILD, the Phenex data may not come until 2016, but we will get ph.2 simtuzumab data in 2h15.
    Apr 28, 2015. 02:29 PM | Likes Like |Link to Comment
  • The FDA is reviewing data on a certain class of diabetes drugs which it says might lead to precancerous changes in the pancreas. The drugs may include Eli Lilly's (LLY) Tradjenta, Merck's (MRK) Januvia, Novo Nordisk's (NVO) Victoza, and Bristol-Myers Squibb's (BMY) Byetta. Labels on the drugs already warn of increased potential for pancreatitis, which is the inflamation of the pancreas. The precancerous changes are new, and would affect future labeling. [View news story]
    i believe they are citing an increased incidence of pre-cancerous lesions, not just inflammation, no?
    Mar 15, 2013. 01:20 PM | Likes Like |Link to Comment
  • The FDA is reviewing data on a certain class of diabetes drugs which it says might lead to precancerous changes in the pancreas. The drugs may include Eli Lilly's (LLY) Tradjenta, Merck's (MRK) Januvia, Novo Nordisk's (NVO) Victoza, and Bristol-Myers Squibb's (BMY) Byetta. Labels on the drugs already warn of increased potential for pancreatitis, which is the inflamation of the pancreas. The precancerous changes are new, and would affect future labeling. [View news story]
    This is not going to end well for Byetta nor Bydureon, i don't think.
    Mar 15, 2013. 01:46 AM | Likes Like |Link to Comment
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