Roche names new Foun­da­tion Med chief; Ako­rn shares dip on FDA warn­ing let­ter; Zai Lab ad­vances piv­otal PARP study

→ Six months af­ter Roche paid $2.4 bil­lion to buy com­plete con­trol of Foun­da­tion Med­i­cine the phar­ma gi­ant is fol­low­ing up by putting its on­col­o­gy prod­uct strat­e­gy chief in charge of the op­er­a­tion. Cindy Perettie will take Troy Cox’s po­si­tion at the helm of Foun­da­tion.

→ In April, dial­y­sis provider Fre­se­nius walked away from $4 bil­lion takeover of spe­cial­ty gener­ic drug­mak­er Ako­rn, cit­ing its in­ves­ti­ga­tion that found Ako­rn had ma­te­ri­al­ly breached the FDA’s da­ta in­tegri­ty re­quire­ments. On Wednes­day, Ako­rn’s woes mul­ti­plied when the FDA slapped a warn­ing let­ter on the com­pa­ny’s De­catur, Illi­nois man­u­fac­tur­ing fa­cil­i­ty on Jan. 4, fol­low­ing an in­spec­tion in April and May last year. The reg­u­la­tor cit­ed sig­nif­i­cant vi­o­la­tions in man­u­fac­tur­ing prac­tices, and sug­gest­ed the prod­ucts in the plant were adul­ter­at­ed. Ako­rn said it will re­spond to the FDA with­in the next 15 days, and ex­pects to con­tin­ue pro­duc­tion in the mean­time. The com­pa­ny’s shares $AKRX were down about 6.6%.

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