The win­ners, and losers, in the ug­ly 2016 race for new drug ap­provals

We’ve known for a few months now that 2016 was go­ing to be a dis­ap­point­ing year for new drug ap­provals. So it was no great sur­prise that the fi­nal tal­ly at the FDA rang up at a mea­ger 22.

Last year at this time, though, we were herald­ing a gen­er­a­tion-high score of 45 OKs, and it doesn’t take a math ge­nius to see how bad the drop was.

Does this sig­nal the end of bio­phar­ma as we know it?

Of course not. Sci­ence is point­ing the way to some of the great­est in­no­va­tions known in drug R&D. Much of this is be­ing ad­vanced by small­er biotech com­pa­nies backed by the bil­lions of dol­lars in­vest­ed in new com­pa­nies — through the pub­lic mar­ket and VCs — over the past three years. So the over­all pipeline re­mains large.

Is it just a tem­po­rary stum­ble that we can quick­ly jump past in 2017?

Not so fast. And maybe you should think twice be­fore ac­cept­ing some of the sooth­ing sug­ges­tions that 2016 was just a tem­po­rary aber­ra­tion we can all over­look now that we’ve be­gun a new year.

New drug ap­provals are like­ly to surge back up in the this year, if for no oth­er rea­son than some of the de­lays we saw on man­u­fac­tur­ing are like­ly to get cleared up, al­low­ing for a green light to some big drugs, while pipelines get a chance to eclipse a no­tably aw­ful year. It won’t take much to clear this hur­dle.

But a year this bad un­der­scores a glar­ing weak­ness in the in­dus­try. The top 10 phar­ma gi­ants, which ac­count for about $70 bil­lion in an­nu­al R&D costs and main­tain a dom­i­nant po­si­tion in late-stage de­vel­op­ment, scored on­ly eight OKs. Eli Lil­ly, Mer­ck and Roche ac­count­ed for six of those. Sanofi and Pfiz­er each got one.

Con­tin­ue read­ing for the en­tire list of 2016 new FDA drug ap­provals with peak sales es­ti­mates and ad­di­tion­al com­men­tary.

Endpoints News

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