Derek Lowe's commentary on drug discovery and the pharma industry. An editorially independent blog from the publishers of Science Translational Medicine. All content is Derek’s own, and he does not in any way speak for his employer.
This story from the New York Times got a lot of attention yesterday, and understandably so. It’s fundamentally about the shortage of some generic drugs, a problem that’s been with us for some years now in one form or another. My own belief is that much of this is a regulatory problem, and I note… Read More
A recent paper on drug development costs did not impress me. But if possible, it impressed Matthew Herper at Forbes even less. That’s the one where the authors looked at a number of companies that had been around long enough to develop one drug – they figured that this would give a cleaner read on… Read More
Here’s another paper on the cost to develop a new drug, a topic about which, I’m convinced, debate will never end. This one is designed as a response to the Tufts estimates on these costs, and I’m not going to help much, because I have some things to debate about this paper myself. The authors… Read More
There’s an interesting fight going on inside Mylan Pharmaceuticals. They, of course, are the longtime generic drug maker whose EpiPen prices have (understandably) made them a lightning rod for complaints about drug pricing in general. This New York Times article will give you the flavor of the company, and most unappetizing it is: To understa… Read More
It’s very early in Scott Gottlieb’s tenure at the FDA, but I like what he has to say about generic drug approvals. Several times here, I’ve gone on about how a lot of the terrible pricing situations we’re seeing in generics are due to gaming of the regulatory system, and how the FDA could do… Read More
This exact point came up around here when we last discussed FDA reform, so it’s good to see it made at length in the New England Journal of Medicine. Remember solanezumab? That was the amyloid-targeting antibody that Eli Lilly kept on investigating in trial after trial, looking for some effect on Alzheimer’s. Last November, the final… Read More
Endpoints has done a great breakdown on the actual costs that Marathon Pharmaceuticals is likely to have incurred while bringing their wildly overpriced old generic steroid to the US market. They did no new registrational studies in the clinic, in case you’re wondering. There was a drug-drug interaction study, ADME work, that sort of thing… Read More
So since drug pricing and FDA regulations are so much in the news, it would seem like the perfect time for a small company to game the system for big profits, right? That’s apparently what Marathon Pharmaceuticals believes. They just got approval for deflazacort, a steroid, as a treatment for Duchenne Muscular Dystrophy. Duchenne is… Read More
An editorial in Cell asks “How Much Longer Will We Put Up With $100,000 Cancer Drugs?” I’m of two minds on questions like that. OK, three minds. The immediate impulse, not an honorable one, is to respond with pure snark, which is always tempting, in the vein of “If you can keep your company going… Read More
OK, enough people have emailed me the press coverage of the students in Sydney making daraprim, which is the drug that Martin Shkreli’s former firm has famously jacked up the price of. From what I can see, a lot of the news stories on this are missing the point. Daraprim is not hard to make in… Read More
