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biomaven0

02/12/12 11:07 PM

#136968 RE: DewDiligence #136957

R&D Spending* Per New Drug



Be very interesting to know this number for all biotechs added together.

Peter
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DewDiligence

02/24/12 3:53 PM

#137816 RE: DewDiligence #136957

Re: FDA mandate

“There is no question that the economic environment has changed dramatically over the last few years. The cost consciousness of payers and those that reimburse drugs has put pressure on the FDA. Although the FDA's mandate says that it is not required to look at the cost-effectiveness of individual medications, there is much more of an acceptance of the fact that it is no longer sufficient of developers of products to simply demonstrate safety and efficacy. They have to demonstrate some sort of cost value. And I think, although the FDA is not mandated to review that information they still feel that pressure.”

—Kenneth Kaitin, Director, Tufts Center for the Study of Drug Development

http://www.cancernetwork.com/practice/content/article/10165/2036366
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DewDiligence

06/26/12 12:34 PM

#144506 RE: DewDiligence #136957

Drug/biotech R&D success is improving, according to Reuters:

http://www.reuters.com/article/2012/06/26/us-drug-improving-idUSBRE85P06H20120626

This is the stat most people have focused on, although it’s not the most consequential one, IMO:

The number of innovative medicines, or new molecular entities, launched globally in 2011 hit a 10-year high of 31, up from 21 in 2010.

Of greater consequence, IMO, is the declining number of phase-3 failures:

the tally of drugs terminated in the final Phase III stage of clinical trials dropped markedly, to 45 in the last three years from 53 in 2008-2010

Inasmuch as phase-3 failures are the biggest component of the fully-allocated cost of bringing a successful drug to market, the factoid above is very encouraging indeed.

R&D expenditure on prescription drugs has effectively plateaued in the past four years, after decades of relentless increases… leading drugmakers spent an aggregate $71.05 billion in 2011. That was 2.5 percent more than in 2010, although part of the rise reflected weakness in the dollar, since a large part of global R&D cash is spent in euros and Swiss francs.

Related drug-development factoids reside in the following posts:

#msg-59909806 Headline story on BIO’s study
#msg-60339665 Phase-transition probabilities (overall database)
#msg-60340131 Phase-transition probabilities (lead vs secondary indications)
#msg-60340768 Success rates in oncology