The FDA ac­cused Chemo­Cen­tryx of ma­nip­u­lat­ing the re­sults of a piv­otal clin­i­cal tri­al used to ap­prove the drug Tavneos, es­ca­lat­ing the agen­cy's ef­fort to pull the treat­ment from the mar­ket.

"New in­for­ma­tion shows that the ap­pli­cant’s un­blind­ed study per­son­nel ma­nip­u­lat­ed end­point re­sults for the Phase 3 study," the FDA said in a let­ter out­lin­ing its con­cerns and de­mand­ing that Am­gen pull the prod­uct. That lan­guage ap­pears to be a far more se­vere ex­pres­sion of con­cern than what has been pub­lic so far.

"CDER can no longer con­clude that there is, or has ever been, a valid demon­stra­tion of sub­stan­tial ev­i­dence of ef­fec­tive­ness for TAVNEOS," the FDA wrote, adding that the al­leged da­ta changes "ir­rev­o­ca­bly com­pro­mis­es the cred­i­bil­i­ty of the study re­sults.”

The pan-RAS space con­tin­ues to gain mo­men­tum, as Ab­b­Vie signs up for a shot at en­ter­ing a field with the po­ten­tial to dras­ti­cal­ly al­ter the treat­ment of cer­tain can­cers.

The Chica­go-area phar­ma gi­ant has signed an agree­ment that gives Ab­b­Vie the ex­clu­sive op­tion to ac­quire a lit­tle-known biotech named Kestrel Ther­a­peu­tics for up to $1.45 bil­lion, ac­cord­ing to a Tues­day press re­lease from Kestrel. The drug will have to hit cer­tain undis­closed de­vel­op­ment mile­stones to bring the ac­qui­si­tion to fruition.

The move comes a few months af­ter Ab­b­Vie was re­port­ed­ly near­ing a deal to buy Rev­o­lu­tion Med­i­cines, but Ab­b­Vie lat­er de­nied those ru­mors.

Rev­o­lu­tion Med­i­cines’ stand­out da­ta in pan­cre­at­ic can­cer en­er­gized the pan-RAS land­scape. Then, Eras­ca got in­to the act with da­ta of its own — and an ac­com­pa­ny­ing le­gal bat­tle that start­ed to brew on Mon­day.

RIO DE JANEIRO, Brazil — For the past two years, Adap­tyv Bio has chal­lenged the AI com­mu­ni­ty to see how good to­day’s mod­els are at de­sign­ing pro­teins. Its lat­est com­pe­ti­tion, pre­sent­ed Mon­day at a top ma­chine-learn­ing con­fer­ence, showed more suc­cess for the field against an even hard­er drug tar­get.

The lat­est con­test fo­cused on a pro­tein called RBX1, a tar­get with­out pub­lished, high-affin­i­ty bind­ing pro­teins. All told, 187 de­sign­ers filed about 240 en­tries that in­clud­ed over 12,000 pro­tein de­signs. A small group of the most promis­ing were se­lect­ed to be syn­the­sized and test­ed in the lab by Adap­tyv. Of 321 mea­sured pro­teins, nine were con­firmed binders to RBX1, re­sult­ing in a 2.8% hit rate. The strongest-bind­ing pro­tein mea­sured at 23.7 nanomo­lar affin­i­ty and was de­signed by Aryan Chan­dak.

In­cyte in­tends to seek ap­proval of its JAK1 in­hibitor pill in the skin dis­ease non­seg­men­tal vi­tili­go af­ter the drug, povorci­tinib, hit in twin Phase 3 tri­als.

The com­pa­ny re­vealed the suc­cess­es on Tues­day as it re­port­ed its first-quar­ter earn­ings.

In the first study, called STOP-V1, 18.9% of pa­tients who took a dai­ly oral 30 mg dose of povorci­tinib for a year had a re­duc­tion of at least 75% on a scale called fa­cial Vi­tili­go Area Scor­ing In­dex (F-VASI75). On­ly 6.8% of place­bo-treat­ed pa­tients hit this thresh­old.

In the oth­er tri­al, STOP-V2, the F-VASI75 goal was al­so achieved by 18.9% of povorci­tinib-treat­ed pa­tients, and 3.1% of place­bo pa­tients. Across both stud­ies, the dif­fer­ences ver­sus place­bo were good for sta­tis­ti­cal sig­nif­i­cance, with p-val­ues of less than 0.001.