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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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In the Pipeline

« And So, 2011 | Main | Detecting Single Cancer Cells »

January 3, 2011

Drug Approvals 2010

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Posted by Derek

2010 wasn't, though, a particularly good year for getting new drugs on the market. But it wasn't an outstandingly bad one, either. The 21 approvals last year are lower than the previous two years (25 and 24), but still better than 2007's 18. It's actually right in the recent range, with the weirdo exception of 2004, which broke into the low 30s for no particular reason that I can see.

Of course, this level of drug development (and the sorts of drugs that we're able to get through) doesn't seem to be enough, considering all the cost-cutting and job-shedding that's been going on. So staying in the range of the past ten years, while it certainly could be worse, is still nothing to celebrate. . .

Comments (7) + TrackBacks (0) | Category: Regulatory Affairs


1. Anonymous on January 3, 2011 12:13 PM writes...

Fortunately, all that brilliant outsourcing that the US pharmas did not only improved the cashouts for the CEOs and execs, but is also destroying India's ecosystem as a bonus. All for just the mere cost of thousands of R&D scientists' jobs! USA! USA!

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2. bbooooooya on January 3, 2011 12:31 PM writes...

The problem with blanket #s like this is that the quality of the drug/application is not taken into account. As has been pointed out, for a young biotech with nothing else late stage in its pipeline, there is no disincentive to not submitting an NDA, even if the company knows it's weak. What else will the CEO do, say to shareholders "well, the drug is not that good, so we'll hold off 5 more years until our preclinical stuff is ready". That works if you already have sales, but if this is a first product no way it will work. Long term is the same, but CEO and cronies get an extra year or so of salary and bonus.

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3. organicchemist on January 3, 2011 4:19 PM writes...

Let's have a discussion on how to make money using organic chemistry.

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4. gyges on January 4, 2011 5:32 AM writes...

A chap called David F Noble died over the Christmas period; as is usual at these times, his work has been re-examined.

Here is an interesting interview he did about peer review as censorship.

The article goes through the history of scientific review and discusses how scientists are forced to submit to the process.

Apologies for going off topic but it is very interesting stuff.

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5. Petros on January 4, 2011 8:37 AM writes...

Well 2010 saw the FDA approve very few NCEs that I would rate as intersting from a medicinal chemists perspective

Fingolimod (Novartis) the first S1P1 receptor drug on the market

Dabigatran (BI), FXa inhibitor 2 years after European approval

Eribulin - Eisai's complex natural product

While denosumab (Amgen) is the pick of the BLAs

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6. drug_hunter on January 4, 2011 8:43 AM writes...

Perhaps in 2011 -- our darkest hour? -- finally we will re-examine the lives and philosophies of the great drug hunters: Paul Janssen, Jim Black, Art Patchett, Paul Anderson, ... their teachings, and their inspiration, may offer us the only path out of the forest.

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7. Anonymous on January 4, 2011 10:12 PM writes...

Dec. 21 2012......we are approaching the moment. By the way, why are all the fish dying and birds are dropping from the sky?? LOL We are seriously taxing the planet without knowing it. It will take a toll in the long run and we are just seeing the tip of the iceburg. Perhaps it's all the pharmaceutical metabolites (think about many drugs are there and how many people take them) being excreted in the urine and feces of unsuspecting and innocent individuals. These entities find their way to our water and food supply. That stuff has to go somewhere!! Not in my backyard LOL.

Hey, just some thoughts...

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