All About Pharmaceuticals

Here’s an example   of the current regulatory framework – you may like it, you may not, but if you’re doing drug research you should know that it’s going on. The way it’s traditionally worked – for decades – has been that a company develops a drug, runs clinical trials, etc., puts together a (huge) data package and sends it off to the FDA. In the oldish days it all went off in hard copy – I remember a celebration when the 18-wheeler pulled out of the loading dock on its way to Maryland, loaded down with box after box of bound copies of the NDA and the associated data. If a company wanted approval for another indication, well, it did something similar: it went out and ran more trials, put a package together, and sent it to the FDA for evaluation. Now, for a long time companies have been working with the agency to try to make this whole process go smoother. You would be well advised to consult with them about whether the trials you’re planning will generate (in their view) data th

Let’s have a look at the recent new drug approvals. 2018 was quite a year, by the numbers.  C&E News  has  a comprehensive roundup : 59 approvals (versus 46 in 2017, which was already a record by itself), and about two-thirds of those small molecules. There are some very  interesting molecules  in the list, and I always recommend that medicinal chemists sit down every so often and look over the structures of approved drugs as if you’re seeing them for the first time (say, as screening hits). You might be surprised at how many of them you find chemically somewhat unappealing – would you aim for an n-hexyl ether in your final structure ( Mulpleta/lusutrombopag ), the heterocyclic ring in the lower section of  Xofluza (baloxivir marboxil) , or think that  3,4-diaminopyridine (Firdapse)  or  Diacomet (stiripentol)  could be drugs at all? Those last two also illustrate the tricky nature of drug approval statistics. Diaminopyridine has been kicking around as a therapy since at lea

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