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It’s mighty tempting to run a little play on words with regard to eyesight in this new year, but I need reading glasses, so far be it from me to pepper a blog with wisecracks about 20-20 vision in 2020. Still, there are a few things to look forward to in this new year, including some great expectations and one or two desperate hopes.
There are a lot of ways to save money without going bankrupt in the process, but health care in the U.S. certainly has not lent itself to that sort of thing. Still, there’s a big opportunity to do just that if one demonstrates an interest in sleep, a subject about which there is little evident interest in Washington, D.C., or in the boardrooms of med tech firms. According to a study by the Rand Corporation, data from five OECD nations suggest that those who sleep...
Now that the existing inventory of FDA-approved transcatheter aortic valve replacement (TAVR) devices has received a green light for patients at low surgical risk, it’s tempting to think this device type has pretty much conquered all that lay before it. That’s not the case, however, as the question of bicuspid valve might be answered in a way that gives Edwards Lifesciences and Medtronic another sizeable patient population for their TAVR offerings. As is widely known, the FDA recently approved two TAVR devices each by Medtronic...
We who write about medical devices rarely suffer for content, but the month of May was unusually cooperative even by our standards. Following are two stories about medical devices that either emerged or resurfaced in the merry month of May, each of which involves a cardiologist and what some of us now think of as not-so-social media. Cabana and the case for catheter ablation We’ve all heard at least a little of the noise about catheter ablation for atrial fibrillation over the years, including assertions...
Life has a lot of unknowns, and one of the big unknowns for 2019 is what the FDA will look like now that Scott Gottlieb has returned to the American Enterprise Institute. Norm Sharpless of the National Cancer Institute has been named the acting FDA commissioner – which by itself doesn’t mean a whole lot, other than that he has to be considered a lead candidate for the job – but the difficulty in knowing where the agency would go in terms of policy under...
In releasing its annual report card for drug manufacturing inspections in which the per-country/region grading curve peaked at 77% and bottomed at 68%, the FDA said, “All of these scores indicate an acceptable level of compliance to CGMPs [current good manufacturing practices] on average.”
It should be motoring to profitability, but nine months after the U.S. launch of its new antibiotic, Zemdri (plazomicin), Achaogen Inc. has filed for chapter 11 bankruptcy and is now selling off its assets.
In many ways, 2018 resembled the previous year in fast motion. Political turmoil accelerated on both sides of the Atlantic, with Asia swept into the fold, while the “estrangement" previously seen between President Donald Trump and the scientific community morphed into global revulsion against a rogue research rule-breaker. Not all was well in biopharma-land, either. The groundswell of anger against rising U.S. drug prices looked likely to spill into multiple pieces of legislation in a rebalanced Congress. And the ongoing tragedy of opioid abuse and addiction prompted the FDA to put the brakes on certain drugs while the CDC warned...
The holidays are (already) here again. Much as we try to push back the calendar, those Thanksgiving doorbuster, Black Friday blowout, Small Business Saturday, Cyber Monday and Giving Tuesday pitches keep knock, knock, knocking at our doors. And those salebrations don’t even count the actual seasonal holidays, like Hanukkah, which begins at sundown on Dec. 2 to kick off an early start to this year’s festivities. Before you hit the stores – or, more likely, that “Purchase Now” icon on your phone – take a spin through these suggestions from the BioWorld team and from our fans and followers. For...
Defying the laws of nature, many drug companies seem intent on proving that what goes up doesn’t have to come down. For them, the sky’s the limit when it comes to U.S. drug prices. Despite all the public outrage and all the talk and threats on Capitol Hill, several drug companies ushered in the second half of 2018 with more price increases. Most of them were “modest” in the single-digit range. But when piled on top of previous hikes, those modest increases add up to skyrocketing prices. Take Seattle Genetics Inc.’s cancer drug Adcetris (brentuximab vedotin). Its wholesale acquisition...
