Thumbs Up/Thumbs Down: The FDA backs an­oth­er R&D scheme, Kite shows its speed while Eli Lil­ly and As­tra stum­ble again


End­points as­sess­es the big bio­phar­ma R&D sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.

An­oth­er price-goug­ing alert for the FDA

Let’s face it. Bio­phar­ma has a bad rep. New drugs come along with jaw-drop­ping prices and the pub­lic feels like it’s get­ting fleeced. The prob­lem, though, has noth­ing to do with tru­ly in­no­v­a­tive new drugs or their price. The US can well af­ford the high cost of in­no­va­tion – with all its ben­e­fits. It’s be­ing tak­en to the clean­ers for the ever ris­ing price of old meds that needs to be the fo­cus. This week’s sto­ry on Marathon’s move to gain an ap­proval for an an­cient steroid called de­flaza­cort sums it all up. Nev­er ap­proved in the U.S., Marathon test­ed it as a mus­cle strength­en­er for Duchenne mus­cu­lar dy­s­tro­phy. And they have scored a slew of ad­van­tages at the FDA, in­clud­ing its se­lec­tion as a rare pe­di­atric ther­a­py. You can be sure that Marathon plans to charge much more than the buck-a-pill price charged by on­line phar­ma­cies in Cana­da. The agency should re­serve its fa­vors for re­al­ly great new drugs. And the in­dus­try needs to learn how to shape an ar­gu­ment that can ac­tu­al­ly win the pub­lic over.

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