Look! Up in the sky! It’s a bird! It’s a plane! It’s . . . another superbug.
Author Archives: Mari Serebrov
‘Indirect’ Fat Clogging NIH’s Arteries
March 12, 2013 – 1:20 pm
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…
Omontys Recall Rings Alarm Over Biosimilars
February 27, 2013 – 9:00 am
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…
Don’t Call Them Generics!
January 29, 2013 – 4:19 pm
When the FDA’s Rachel Sherman said the biggest challenge the agency faces with biosimilars is educating the public, she wasn’t exaggerating. An article in the New York Times shows just how big of a challenge it’s going to be.
Biosimilars are Changing the Global Game
January 23, 2013 – 10:01 am
I recently took a few months off from daily deadlines to explore the evolving world of biosimilars for the newest BioWorld Data report, The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies. It was quite an eye-opening adventure.
Grappling with the Ethics
September 5, 2012 – 9:45 am
With science boldly taking us where we’ve never gone before, we’re exploring new worlds and stretching the boundaries of our universe. While these are exciting times for the adventurer in us, they can be discomfiting for our inner ethicist.
Where’s Rube Goldberg When You Need Him?
August 8, 2012 – 10:36 am
What’s the difference between Congress and a Rube Goldberg contraption?
Caught in Its Own Snare
July 16, 2012 – 2:30 pm
A hunter walks into a bar and says, “Did you hear the one about the FDA?”
The Star-Struck FTC
July 2, 2012 – 12:57 pm
The FTC seems to have come down with a bad case of star envy. Not content with its supporting role as implementer of laws duly passed by Congress, the agency is intent on rewriting the script, casting itself as headliner…
The Death of ‘Innocent Until Proven Guilty’?
February 16, 2012 – 4:04 pm
Unlike every other country in the world at the time, the U.S. founded its judicial system on the premise “innocent until proven guilty.” Under that guiding principle, the burden of proof – in any enforcement action – lies with the…
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