Mer­ck­'s C-suite shake­up, Eli Lil­ly stirs fresh Alzheimer's con­tro­very, play by play of Am­gen's $2B buy­out, and more

Wel­come back to End­points Week­ly, your re­view of the week’s top bio­phar­ma head­lines. Want this in your in­box every Sat­ur­day morn­ing? Cur­rent End­points read­ers can vis­it their read­er pro­file to add End­points Week­ly. New to End­points? Sign up here.

Ones of the coolest parts of this job is get­ting the chance to dis­cuss cut­ting-edge sci­ence and tech­nolo­gies with the peo­ple be­hind them. You can see plen­ty of those con­ver­sa­tions in this week’s line­up. — Am­ber Tong

Mer­ck’s C-cuite shake­up

On the heels of Roger Perl­mut­ter and Ken Fra­zier’s de­par­ture, Michael Nal­ly has left his chief mar­ket­ing of­fi­cer post at Mer­ck for green­er pas­tures. Re­port­ed­ly in the run­ning for the CEO job as Fra­zier re­tires, Nal­ly ul­ti­mate­ly lost out to CFO Robert Davis, who is now lead­ing a fresh C-suite with Dean Li as R&D chief and Frank Clyburn, in­au­gur­al pres­i­dent of the glob­al on­col­o­gy busi­ness and most re­cent­ly chief com­mer­cial of­fi­cer, in Nal­ly’s pre­vi­ous po­si­tion.

Eli Lil­ly stirs Alzheimer’s con­tro­ver­sy

Noth­ing drums up ex­cite­ment and con­tro­ver­sy quite as in­stant­ly and in­tense­ly as Alzheimer’s — as Eli Lil­ly has once again demon­strat­ed with the pre­sen­ta­tion of mixed re­sults from its Phase II tri­al of do­nanemab. While the phar­ma gi­ant her­ald­ed a sta­tis­ti­cal­ly sig­nif­i­cant re­sult for the un­con­ven­tion­al pri­ma­ry end­point it chose, even the op­ti­mists were cau­tious to jump to con­clu­sions while crit­ics homed in on the meh num­bers on the sec­ondary end­points (which rep­re­sent­ed more tra­di­tion­al met­rics used in pre­vi­ous stud­ies) and side ef­fects. Lil­ly, though, main­tained the da­ta were “tremen­dous­ly im­por­tant” and is up­beat about its up­com­ing piv­otal be­fore head­ing to reg­u­la­tors — by which time they may al­so have a prece­dent in Bio­gen’s ad­u­canum­ab.

FTC pledges phar­ma M&A crack­down

Re­bec­ca Kel­ly Slaugh­ter didn’t mince words in call­ing out phar­ma megamerg­ers. Now as FTC’s act­ing chair, she’s vow­ing to “re­think” the an­titrust watch­dog’s re­view ap­proach by set­ting up an in­ter­na­tion­al work­ing group to scru­ti­nize these deals and vow­ing to con­sid­er new pro­posed deals in light of con­duct like price fix­ing, re­verse pay­ments and oth­er reg­u­la­to­ry abus­es. The group will com­prise state at­tor­neys gen­er­al, the De­part­ment of Jus­tice, as well as UK, Eu­ro­pean and Cana­di­an reg­u­la­to­ry coun­ter­parts. At least one big buy­out may be on the line.

FDA holds the line on Covid-19 an­ti­bod­ies

Emerg­ing vari­ants of the coro­n­avirus are threat­en­ing to un­der­mine the three an­ti­body treat­ments from Eli Lil­ly and Re­gen­eron that have been au­tho­rized for emer­gency use, and the FDA is vow­ing to stay on top of it. The US gov­ern­ment is no longer dis­trib­ut­ing Lil­ly’s bam­lanivimab in­to Cal­i­for­nia, Ari­zona and Neva­da be­cause of the preva­lence of a vi­ral vari­ant, act­ing com­mis­sion­er Janet Wood­cock told a meet­ing of doc­tors. And af­ter re­leas­ing a let­ter re­quir­ing the two com­pa­nies to mon­i­tor the ac­tiv­i­ties of their drugs, her agency spelled out the avail­able da­ta on the per­for­mance of bam­lanivimab alone, bam­lanivimab plus ete­se­vimab, and the imde­vimab/casiriv­imab cock­tail.

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