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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
The FDA Friday approved a third indication for Bristol-Myers Squibb’s Opdivo, this time to treat metastatic non-squamous non-small cell lung cancer that has progressed during or after platinum-based chemotherapy. 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
A ruling by the Court of Justice of the European Union has clarified when drug patents expire, in a decision that could prove lucrative for drugmakers even though it adds only a few days of patent protection. 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
Sen. Amy Klobuchar (D-Minn.) is calling on the Federal Trade Commission to investigate certain drugmakers for possible antitrust violations in light of recent drug price increases. Read More
Eight drugmakers have contributed more than $10 million in recent weeks, with Johnson & Johnson putting in more than half the total, to fight a proposed November 2016 ballot initiative in California that would cut state spending on prescription drugs. Read More
The FDA issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies and all for data integrity issues. Read More
President Barack Obama late Wednesday signed into law a bill to compensate patients who participate in clinical trials involving rare diseases. Read More