Bio­phar­ma in­dus­try rep­re­sen­ta­tives are tak­ing is­sue with some of the FDA’s more po­lit­i­cal pro­pos­als in the next round of user fee agree­ments, par­tic­u­lar­ly ones that would lim­it the small busi­ness waiv­er to on­ly US ap­pli­cants and re­duce user fees for com­pa­nies that run their Phase 1 tri­als in the US.

Among the in­dus­try con­cerns: Is PDU­FA "the most ap­pro­pri­ate mech­a­nism" for in­cen­tiviz­ing more clin­i­cal de­vel­op­ment in the US? That's ac­cord­ing to the lat­est meet­ing min­utes from a se­ries of Feb­ru­ary ne­go­ti­a­tions lead­ing up to the eighth it­er­a­tion of the pre­scrip­tion drug user fee pro­gram and post­ed on Thurs­day.

Mi­lan-based Recor­dati con­firmed Thurs­day that it has re­ceived a buy­out of­fer north of $12 bil­lion.

The com­pa­ny said in a press re­lease that pri­vate eq­ui­ty firm CVC Cap­i­tal Part­ners has sub­mit­ted an of­fer of €52 per share, equal­ing about $12.6 bil­lion in to­tal. Recor­dati said it has not yet re­viewed the of­fer.

CVC, which is head­quar­tered in Lux­em­bourg and pri­mar­i­ly fo­cus­es on Eu­ro­pean in­vest­ments, has a rough­ly 47% stake in Recor­dati as of Feb­ru­ary.

Recor­dati has a port­fo­lio of rare dis­ease drugs in­clud­ing Is­tur­isa for Cush­ing's dis­ease, an en­docrine sys­tem dis­or­der, and Qarz­i­ba for cer­tain neu­rob­las­toma pa­tients. Qarz­i­ba is not ap­proved in the US yet, though Recor­dati is pur­su­ing ap­proval.

The com­pa­ny al­so sells the drug Carbaglu, which treats a rare meta­bol­ic dis­or­der that caus­es high lev­els of am­mo­nia in the blood.

Who knows what’s go­ing to hap­pen to the Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices?

For­mer mem­ber Robert Mal­one sug­gest­ed in a string of so­cial me­dia posts last Thurs­day that the group was go­ing to be dis­band­ed, which the gov­ern­ment quick­ly re­fut­ed. That’s af­ter a fed­er­al judge in Boston ef­fec­tive­ly paused the com­mit­tee’s work, and its de­ci­sions to date, in a rul­ing ear­li­er this month. (Mal­one says he has now re­signed from the com­mit­tee.)

It would be eas­i­er to dis­miss this as dra­mat­ic the­ater if the group wasn’t so im­por­tant. HHS Sec­re­tary Robert F. Kennedy Jr. fired every sit­ting mem­ber of ACIP last June and re­made it, large­ly to fit his vac­cine-skep­ti­cal ac­tivist past. Since then, the group has de­vel­oped a rep­u­ta­tion for fits of out­burst and con­fu­sion. Sci­ence aside, the meet­ings have been, frankly, a mess. Com­mit­tee mem­bers have be­rat­ed CDC of­fi­cials over their pre­sen­ta­tions; votes have been post­poned over con­fu­sion; and new mem­bers have been ap­point­ed weeks be­fore planned meet­ings.

The pill ver­sion of No­vo Nordisk's block­buster We­govy showed what was pos­si­ble when drug chemists turned pep­tides in­to oral mol­e­cules. Now in­vestors have found their next re­lat­ed bet.

Pin­na­cle Med­i­cines, a two-year-old start­up based in Shang­hai with op­er­a­tions out­side Philadel­phia, has at­tract­ed an $89 mil­lion Se­ries B, the com­pa­ny said Thurs­day. It has raised $134 mil­lion to bring its im­munol­o­gy and car­diometa­bol­ic med­i­cines in­to hu­man test­ing.

The start­up hopes to fol­low in the foot­steps of oth­er oral pep­tides in the car­diometa­bol­ic and im­munol­o­gy fields that have con­sumed re­cent head­lines, Pin­na­cle CEO Jonathan Wang said in an in­ter­view. Those in­cludes Novo's oral We­govy and John­son & John­son's pso­ri­a­sis pill Ico­tyde.

"We're re­al­ly de­vel­op­ing the next gen­er­a­tion oral pep­tides serv­ing large mar­kets, and it's mov­ing very quick­ly," Wang said.

There’s a rea­son lots of com­pa­nies are work­ing on GLP-1-based drugs for obe­si­ty: The oth­er stuff tends not to work. The lat­est biotech to learn this the hard way is Wave Life Sci­ences, which said Thurs­day that its obe­si­ty can­di­date yield­ed weight loss of just 1% more than place­bo in an ear­ly-stage study.

The com­pa­ny’s stock WVE tanked more than 55% when trad­ing opened on Thurs­day morn­ing.

Pa­tients in the Phase 1 part of the IN­LIGHT study were giv­en a sin­gle 240 mg dose of WVE-007, a small in­ter­fer­ing RNA drug. Six months lat­er, the place­bo-ad­just­ed weight loss was 0.9%. The thresh­old for ap­prov­abil­i­ty for obe­si­ty meds has been set by the FDA at 5%.