Vinay Prasad's sec­ond ex­it from FDA lead­er­ship af­ter less than a year in his po­si­tions did­n't come as a ma­jor sur­prise. But with his two po­si­tions now left to fill — as the di­rec­tor of CBER and as chief med­ical and sci­en­tif­ic of­fi­cer — there are ques­tions about the agen­cy's fu­ture di­rec­tion with vac­cine and rare dis­ease drug re­views.

Hailed as a ge­nius by FDA Com­mis­sion­er Mar­ty Makary, Prasad left amid a se­ries of mis­steps over the last few weeks that in­clud­ed hold­ing a press con­fer­ence — on back­ground as a "se­nior of­fi­cial" but now wide­ly and pub­licly named as Prasad — on a drug ap­pli­ca­tion that's still un­der re­view, and walk­ing back a refuse-to-file let­ter for Mod­er­na's flu vac­cine in Feb­ru­ary that fu­eled frus­tra­tion at the White House.

The FDA has hand­ed In­cyte a com­plete re­sponse let­ter for a la­bel ex­pan­sion of the com­pa­ny's mon­o­clon­al an­ti­body Zynyz over is­sues at a third-par­ty man­u­fac­tur­ing site in In­di­ana that was for­mer­ly owned by Catal­ent.

In­cyte’s sup­ple­men­tal BLA for Zynyz as a treat­ment for metasta­t­ic non-small cell lung can­cer was re­ject­ed due to prob­lems with the fac­to­ry’s “reg­u­la­to­ry com­pli­ance,” ac­cord­ing to an SEC fil­ing.

There were no is­sues di­rect­ly re­lat­ed to Zynyz, in­clud­ing with the drug's ef­fi­ca­cy, safe­ty and third-par­ty drug sub­stance man­u­fac­tur­er, the fil­ing states. The ap­pli­ca­tion was sup­port­ed with da­ta from In­cyte’s Phase 3 POD1UM-304 study.

In­cyte is now the third com­pa­ny to re­ceive a CRL due to on­go­ing is­sues at the trou­bled fa­cil­i­ty in Bloom­ing­ton, IN. Last year, Re­gen­eron and Schol­ar Rock were al­so hit with CRLs for drugs made at the fac­to­ry, which is now owned by No­vo Nordisk.

Hims & Hers has agreed to of­fer No­vo Nordisk’s GLP-1 obe­si­ty and di­a­betes treat­ments on its web­site and lim­it ac­cess to com­pound­ed ver­sions.

The move seem­ing­ly ends a con­flict that es­ca­lat­ed last month when the tele­health com­pa­ny launched a com­pound­ed ver­sion of No­vo’s new­ly ap­proved We­govy weight loss pill, draw­ing a law­suit from the phar­ma gi­ant and in­tense scruti­ny from reg­u­la­tors in­clud­ing the FDA and HHS.

As part of the agree­ment an­nounce­ment Mon­day, Hims said it would no longer ad­ver­tise com­pound­ed GLP-1 of­fer­ings on its plat­form or in its mar­ket­ing. Al­so on Mon­day, No­vo Nordisk filed a no­tice that it has dis­missed all claims against Hims with­out prej­u­dice, but it said in a news re­lease that it re­served the right to re­file in the fu­ture.

Ipsen is pulling its can­cer drug Tazverik from the mar­ket af­ter an in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee found safe­ty con­cerns in a con­fir­ma­to­ry tri­al.

The com­mit­tee re­port­ed cas­es of sec­ondary can­cers that be­gin in blood-form­ing tis­sue, al­so known as hema­to­log­ic ma­lig­nan­cies, in a fol­lic­u­lar lym­phoma study dubbed SYM­PHO­NY-1. The tri­al pit­ted Tazverik plus the im­munother­a­pies lenalido­mide and rit­ux­imab as a sec­ond-line treat­ment against the lat­ter two stan­dard-of-care med­i­cines alone.

Ipsen said it’s with­draw­ing Tazverik im­me­di­ate­ly for all of its ap­proved us­es, in­clud­ing fol­lic­u­lar lym­phoma and ep­ithe­lioid sar­co­ma. A spokesper­son de­clined to com­ment on the num­ber of hema­to­log­ic ma­lig­nan&