Lilly’s Failed Solanezumab: Could It Get Another Chance In A ‘Silicon Valley’ FDA?
Alzheimer drug’s development was discontinued after third disappointing Phase III trial, but given the kind of FDA commissioner candidates getting meetings with the President, maybe Lilly should reconsider.
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3D Printing And The First Amendment: What A Gun Rights Case Could Mean For US FDA
A landmark legal case over 3D-printed guns doesn’t involve FDA – but it is worth considering how the issues are likely to apply to the drug approval process in years to come. The right to bear arms may rely on the Second Amendment, but the key for FDA is how courts look at the First Amendment in the context of new technology.
Looser Efficacy Standards Could Waste Taxpayer Dollars On Useless Drugs, NEJM Says
Editorial cites Lilly's failed Alzheimer's candidate solanezumab to argue that looser efficacy standards could result in Medicare paying for ineffective drugs, but it's unlikely that a Scott Gottlieb-led FDA would have approved the drug.
Trump Meets With Two US FDA Commissioner Candidates; Third Still Lurking
O'Neill and Srinivasan head to Trump Tower, but Gottlieb has not been eliminated.