We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Eli Lilly, under pressure from many quarters over the price of its medicines, released a report over the weekend saying the net price of its insulin has fallen more than eight percent over the past five years. Read More
Drugmakers should use industry-driven voluntary standards but regulators will give priority to standards that are internationally harmonized, the FDA said in a final guidance issued Monday. Read More
The FDA has pushed the pause button on Sanofi’s and Lexicon’s diabetes treatment Zynquista (sotagliflozin) two months after an advisory committee panel deadlocked over the drug’s safety profile. Read More
Drug sponsors who want to use natural histories to help develop treatments for rare diseases should draw up well-defined statistical analysis plans and probably even hire statisticians to help develop the histories, the FDA said in new draft guidance issued Friday. Read More
The decision is another blow for Pfizer, which saw claims of a separate Prevnar 13 patent invalidated following several inter partes reviews in 2017. Read More