Author Archives: Mari Serebrov

Left on the garbage heap of the 114th Congress?

Add this to the list of things the 114th U.S. Congress likely won’t get done before it fades into history on Jan. 3: Providing relief from the inter partes review (IPR) intimidation racket. It’s not for want of trying. But…

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Will biosimilar carve-outs put R&D for older MAbs on ice?

Unintended consequences. It’s a term that’s bandied about all too often in Washington these days, as it’s become the PC way for lawmakers and agencies like the FDA to save face when they have to admit, “Oops, we didn’t think…

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An end to Charlotte’s web?

In the annals of popular literature, TV shows and movie scripts, only a handful of pigs have achieved mega stardom: Napoleon, who took over a farm and assassinated his political rivals; Arnold, who epitomized the couch potato at Green Acres;…

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Building a wall to keep companies in

They may not realize it, but many Americans woke up this morning with their retirement portfolio worth less than it was a week ago. And it could be worth less tomorrow and even a year or a decade from now…

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Ignoring the science for a bigger box of crayons

Once upon a time in the days before enlightenment, we tried to use science to develop our drugs. Believe it or not, researchers actually had to come up with a hypothesis of how a drug might work, what disease it…

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No joy in Bio-ville

Whether naughty or nice in 2015, Drugmakers received not what they wanted And not what they needed, For the biggest “must-haves” on their wish list Went mostly unheeded.   At the top of that list, and repeated quite often, Was…

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An inconvenient truth

Too often, drugmakers confuse convenience with quality of life, investing untold R&D resources in devising longer-acting formulations and then calling it “innovation.” The only innovation is in how it fends off competition by extending their patent protection. Such “advances” ignore…

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Precision medicine in the real world

In a perfect world, doctors would have the diagnostics to determine the right treatment for each patient at the right dose and the right time. It would be called precision medicine. In our world, researchers, doctors and patients are teased…

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Better Rx needed to treat drugmakers’ PR malady

Biopharma has a bad PR disease. The diagnosis is pretium offensus, otherwise known as “sticker shock.” The infectious condition has two causes: enormous, inexplicable, overnight price hikes and six-figure drug prices that spread from headlines to become a viral meme…

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Lessons learned from You-Know-Who

Duchesnay Inc.’s 15-minutes of fame for its morning sickness drug arguably turned into a few hours’ worth by time the drugmaker complied with an FDA warning letter demanding a corrective ad to offset the omission of risk information in paid…

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