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The Patent Trial and Appeal Board has invalidated a patent for Novartis’ multiple sclerosis drug Gilenya, in one of the first successful uses of the inter partes review process by generics drugmakers. Read More
Presidential candidate and Senate HELP Committee member Bernie Sanders said Friday that he plans to vote against confirming Robert Califf as the new FDA commissioner, citing Califf’s strong ties to industry. Read More
Drugmakers are urging the FDA to clarify how and why the consumer brief summary in direct-to-consumer print advertisements should differ from FDA-approved patient labeling and medication guides. Read More
The FDA is planning two surveys of 900 adults each to assess the effect of including more complicated information about prescription drugs in direct-to-consumer television advertisements. Read More
The House Energy & Commerce Committee is once again demanding information on the status of all patients in NIH clinical trials affected by the shutdown of the agency’s drug compounding facility, despite receiving a letter from NIH saying there were no negative impacts on affected patients. Read More