Monday, June 30, 2008

While You Were Beating Up on Germany

Congratulations to our Spanish readers, whose national side deservedly defeated Germany yesterday 1-0 in the Euro 2008 final. The victory was Spain's first in a major tournament in 44 years, which basically makes them the Philadelphia of Europe. Except for, you know, the winning.

In industryland this morning the WSJ asks on Page One whether Vioxx and other recent high-profile drug safety issues has fundamentally altered the path of drug regulation in the US. Industry executives certainly think so--Schering Plough's Fred Hassan is front and center in the article, talking about how FDA's paradigm shift has caused him to take a harder look at the company's drug candidate portfolio. FDA's Janet Woodcock is on the scene to dutifully make the counterargument.

Any of this sound familiar? By now the woeful approval totals of 2007 are old news. And if as the article suggests (and as we agree) there is plenty of blame to go around (much of it for industry for "for allegedly manipulating clinical data, concealing dangerous side effects and aggressively promoting risky products, which created widespread mistrust"), there should be, and are, plenty of pharma rethinking their pipeline strategies.

Where the article doesn't go--and this may point to a lack of ideas or transparency about those ideas on Pharma's part--is just how the industry can address both it's own lack of productivity and a difficult regulatory climate.

A few other tidbits to get you caught up from a sunny weekend, below:
  • To CT or not CT? That is the question the NY Times asks in this piece that details the increasing use of expensive CT angiograms, and uses the procedure to illustrate the trend in the US that sees patients and doctors utilizing expensive new technologies and procedures without concrete proof that novelty necessarily leads to better outcomes.
  • Not this weekend, darling, I've got a headache (meeting): The American Headache Society met in Boston over the past few days. Get yer migraine news here.
  • Plenty of complaining and hand wringing in the UK about the state of their local market, access to new drugs, and the climate for building drug companies this past week. But the Guardian reports that the NHS may be about to circumvent NICE to grant access to approved therapies before the pharmaco-economics body has its say, which will surely be a welcome respite for drug companies.
  • The long, strange trip of the latest cure for murine cancer is detailed by Reuters, here. Researchers (led by the late Judah Folkman) writing in Nature Biotechnology describe the fungal origins and nanotechnology improvements to the orally available angiogenesis inhibitor lodamin, now licensed by SynDevRx and poised to enter clinical trials in 2009.
  • And finally ... everything you always wanted to know about vasectomy.

image from flickr user BegoƱa Valverde used under a creative commons license

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