Author Archives: Mari Serebrov

Old news, yet still making headlines

High drug prices are old news. Old, as in 19th century old. But that doesn’t mean they aren’t breaking news today. Breaking, as in breaking the family budget. One of the speakers at the Institute of Medicines National Cancer Policy…

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Let the conversation begin

“Communication about how certain treatments are working in certain patients is happening through a multitude of media around the globe. These conversations between and among doctors, patients, researchers, and scientists in academia and industry should be facilitated. This includes the…

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Hamburg: Society needs to weigh in

Including the patient voice in the drug approval process could produce a fundamental shift in the risk-benefit equation of a new drug. But first, the FDA has to figure out how to do it, and that may take a broader…

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Biosimilar regulation: 1984 v. 2014

It’s 1984. The year opens with the demise of Ma Bell, as the Bell System is broken into smaller, regional telephone companies. The idea is to end Ma’s nationwide monopoly, but the result is a handful of smaller monopolies since there…

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It’s How You Look at the Vial

What’s in a biosimilar name? That depends on whether the vial is half empty or half full. Seeing it as half full, many generic makers focus on the similarities between a follow-on and its reference biologic. Because of those similarities,…

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Playing Truth and Consequences with NIH Grants

When it comes to the National Institutes of Health’s (NIH) funding for medical research, it’s not a matter of truth or consequences. It’s more like truth and unintended consequences. Cheered on by prominent researchers, the NIH has embarked on an…

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Patients Want More than Check-the-Box Experience

Patients getting their four minutes to say how an experimental drug changed their life or gave them hope have become a routine part of nearly every FDA advisory committee meeting – as routine as the call to order or the…

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Where’s Superman When He’s Needed?

Look! Up in the sky! It’s a bird! It’s a plane! It’s . . . another superbug. The invasion of the multidrug-resistant superbugs is not a nightmare in the making. It’s already here. And it could be years before a…

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‘Indirect’ Fat Clogging NIH’s Arteries

In the days before the sequester tightened Washington’s belt, the National Institutes of Health (NIH) and several other federal agencies sent up warning shots of just what was at stake. Under the automatic budget cuts intended to put the national…

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Omontys Recall Rings Alarm Over Biosimilars

Despite what the New York Times and its echoers have said, makers of innovative biologics have legitimate reason to sound alarms about automatic substitution of biosimilars that have not proven their interchangeability – and it’s not just because of the…

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