The class of 2017's win­ners and losers: A year of 'non­stop sci­en­tif­ic achieve­ments' rais­es trou­bling is­sues

End­points News presents this 7,000 word spe­cial re­port on the 46 new drugs ap­proved in 2017 by CDER. Keep read­ing and learn how the big play­ers fared in the lat­est grade card on pro­duc­tiv­i­ty, and much more. In­cludes a search­able ta­ble of spon­sors, in­di­ca­tions, and ap­proval path­ways, such as Or­phan, BTD and PRVs — and chart of FDA nov­el drug ap­provals dat­ing back to 1996.

There was a lot to cel­e­brate last year. Cham­pagne corks were popped for dra­mat­ic ad­vances in cell and gene ther­a­pies. An­a­lysts ap­plaud­ed a line­up of po­ten­tial block­busters that won a green light from the FDA. And some pa­tients who once faced death sen­tences or chron­ic dev­as­tat­ing dis­eases now live in hope of a new wave of pos­si­ble cures.

To top it off the FDA stretched hard in the last few weeks of 2017 and man­aged to ac­cel­er­ate a slate of Q1 PDU­FA de­ci­sions in or­der to pro­vide a mar­ket­ing pass on the biggest batch of new drugs since 1996 — which still holds the one-year record for reg­u­la­to­ry nods. Af­ter last year’s aw­ful strike­out record and short ap­proval list, who wouldn’t of­fer up thanks for a boun­ti­ful crop?

Feel­ing good now? OK, but there’s an­oth­er side to that coin.

While big and small play­ers en­joyed some dra­mat­ic wins in 2017, the lag­gards in the busi­ness with a weak rep for in­no­va­tion con­tin­ue to raise ques­tions about the fun­da­men­tal strat­e­gy in place for achiev­ing a turn­around af­ter a decade-long de­cline in Big Phar­ma’s ROI. These new ther­a­pies that are mak­ing the reg­u­la­to­ry grade come with eye-pop­ping price tags that will leave the en­tire in­dus­try in the glare of a pub­lic spot­light that can light up de­bates in Wash­ing­ton DC. And ques­tions about a grow­ing bub­ble in on­col­o­gy R&D are like­ly to re­ver­ber­ate through the com­ing year.

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