Innovation

The PCSK9 Inhibitor Conundrum

September 23, 2016

Medicine is at a crossroads; cardiology in particular. I saw this fact magnified at the American Society for Preventive Cardiology’s recent town hall on access barriers to PCSK9 inhibitors.

FDA Hearings Underscore Need for Clear Policy on Biosimilars

July 20, 2016

July 12 and 13 hearings of the FDA’s Arthritis Advisory Committee cleared the way for two new biosimilars, adalimumab and etanercept. The committee unanimously supported manufacturers’ applications for the drugs – but that wasn’t the only point of consensus. Participants and even committee members expressed concerns about unfinished regulatory policy and the need to prioritize patient safety.

Congress’ Proposed Zika Funding: Too Little, Too Late?

May 24, 2016

Three months after President Barack Obama requested congressional funding to fight the Zika virus, the House of Representatives has authorized $622 million in aid. But will congressional funding be too little, too late for those fighting Zika?