A New Delivery System for Next-Generation Cell and Gene Therapies

Posted by Maria Whitman on Thu, Apr 25, 2019

Kris Elverum of Turnstone Biologics co-wrote this blog post with Maria Whitman.

The evolution of medicines from small molecules to proteins has greatly advanced patient care, and up until now, our system of therapeutic delivery in the U.S. commercial system has been built with these therapeutics in mind. The next generation of cellular and gene therapies holds tremendous promise for patients, but only if the existing delivery system is revamped. There’s a real risk that most patients won’t benefit from these therapies as stakeholders struggle to find successful business models. In a recent article for Nature’s Gene Therapy, my industry colleague, Kris Elverum, and I take a critical look at the U.S. system and outline what needs to change to make approved cell and gene therapies accessible to patients.


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Even in a Favorable Regulatory Environment, Will Biosimilars Gain Traction in the US This Year?

Posted by Pratap Khedkar on Fri, Jan 25, 2019

Christina Corridon co-wrote this blog post with Pratap Khedkar.

Despite 16 approvals in the last four years, just six biosimilars currently are being marketed stateside. The U.S. biosimilars market hasn’t progressed as anticipated, yet some experts are wondering whether the biologic follow-ons can redeem themselves with a breakout year in 2019.

The U.S. biosimilars market has a tough road ahead. The WAC list price differential between biosimilars and the originator drugs is hovering around 30%, on average, which likely isn’t speeding biosimilars’ adoption in the U.S. Rather than playing the long game and waiting for the U.S. landscape to become more attractive, some biosimilar manufacturers like Momenta are choosing to exit the market. And others like Pfizer have shuttered their preclinical biosimilar programs to focus their efforts elsewhere. On the flip side, the Trump administration has zeroed in on drug pricing and biosimilars as priorities—and, of course, the two are intertwined.


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Despite the FTC’s Objections, a Mega-Provider Healthcare System Could Be on the Horizon

Posted by Paul Darling on Wed, Aug 03, 2016

The current U.S. healthcare climate seems to produce a significant announcement each week of a hospital merger or acquisition. In fact, more than 100 provider mergers are anticipated for 2016. Amidst all of this M&A activity, the Federal Trade Commission (FTC) has been issuing and winning antitrust challenges for many of the larger provider M&As. Until recently, the FTC has been undefeated in all of the cases that it has challenged.


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