FDA Com­mis­sion­er Rob Califf told BIO CEO Rachel King on Wednes­day that it’s “im­pos­si­ble to ar­gue that the US is do­ing well in health,” high­light­ing high drug prices and mis­in­for­ma­tion as two key chal­lenges.

The com­mis­sion­er al­so took the op­por­tu­ni­ty to dis­cuss ac­cel­er­at­ed ap­proval re­forms, at­tri­tion at the agency and the In­fla­tion Re­duc­tion Act, which came in­to fo­cus ear­li­er this week when Mer­ck filed a law­suit call­ing parts of the drug pric­ing law a sham. In­dus­try crit­ics have ar­gued that the leg­is­la­tion will have a chill­ing ef­fect on in­no­va­tion.

When asked about the IRA, Califf re­spond­ed that “the prices of drugs are too high.”

“We have to come up with a bet­ter sys­tem. And the IRA is an ef­fort to do that,” he said, lat­er adding that “all of these big laws have im­per­fec­tions,” but he’s “not at lib­er­ty to talk about spe­cif­ic de­tails of what I think is im­per­fect.”

He dis­cussed ramp­ing up com­mu­ni­ca­tions with CMS, not just as part of the IRA, but “on mul­ti­ple fronts," adding that "one thing we're talk­ing about is what to do about obe­si­ty drugs right now be­cause CMS is pro­hib­it­ed from pay­ing for obe­si­ty drugs if that's the on­ly in­di­ca­tion."

“There’s some­thing miss­ing in the equa­tion by which we trans­late all this amaz­ing in­no­va­tion in­to prod­ucts and ser­vices that help the pop­u­la­tion,” he said gen­er­al­ly.

CMS said ear­li­er this year that it in­tends to work close­ly with the FDA on ac­cel­er­at­ed ap­proval pay­ment re­forms in a pi­lot pro­gram de­signed to “re­duce Medicare spend­ing on drugs that have no con­firmed clin­i­cal ben­e­fit.”

The FDA said Wednes­day that the con­fir­ma­to­ry tri­al that Ei­sai and Bio­gen ran to show their new Alzheimer's drug has a clin­i­cal ben­e­fit did in­deed have one, lin­ing Leqem­bi up for a like­ly full ap­proval next month af­ter get­ting an ac­cel­er­at­ed nod in Jan­u­ary.

Ahead of Fri­day's ad­vi­so­ry com­mit­tee meet­ing, which fea­tures just 6 vot­ing mem­bers, FDA re­view­ers af­firmed what Ei­sai and Bio­gen said at the time about the re­sults of the con­fir­ma­to­ry tri­al, known as CLAR­I­TY AD, adding that:

The agency al­so said that the pos­i­tive find­ing on the pri­ma­ry end­point is sup­port­ed by sta­tis­ti­cal­ly sig­nif­i­cant re­sults for all four mul­ti­plic­i­ty-con­trolled sec­ondary end­points, "in­clud­ing clin­i­cal end­points cap­tur­ing dis­tinct in­for­ma­tion re­gard­ing cog­ni­tive de­cline."

As far as safe­ty-re­lat­ed is­sues, which in­clude amy­loid-re­lat­ed imag­ing ab­nor­mal­i­ties (ARIA), cere­bral he­m­or­rhage, and in­fu­sion-re­lat­ed re­ac­tions and hy­per­sen­si­tiv­i­ty, the FDA re­view­ers sound­ed pos­i­tive again, say­ing the "risks do not ap­pear to pre­clude tra­di­tion­al ap­proval. Risk can be mit­i­gat­ed through a de­scrip­tion in la­bel­ing and rec­om­men­da­tions for mon­i­tor­ing and dose man­age­ment guide­lines as pro­vid­ed for in la­bel­ing."

"I think we feel very com­fort­able about Fri­day," Ei­sai's US CEO Ivan Che­ung told End­points News in a phone in­ter­view Wednes­day. "We wel­come any pan­el mem­ber ask­ing any ques­tion."

He said he did­n't know why there were on­ly 6 vot­ing mem­bers on the com­mit­tee, adding that there's vari­abil­i­ty in the size of the com­mit­tees.

Pro­mo­some, a small biotech linked to Scripps Re­search In­sti­tute, sued Mod­er­na, Pfiz­er and BioN­Tech in fed­er­al court — say­ing the three com­pa­nies vi­o­lat­ed a patent is­sued to its mR­NA tech­nol­o­gy al­most a decade ago.

The Stam­ford, CT-based biotech filed two law­suits in US Dis­trict Court in the South­ern Dis­trict of Cal­i­for­nia in San Diego, one against Mod­er­na and the oth­er against Pfiz­er and BioN­Tech, ac­cus­ing the com­pa­nies of patent in­fringe­ment and ask­ing for its “right­ful share” of bil­lions of dol­lars in rev­enue from the sale of their Covid-19 vac­cines: Spike­vax and Comir­naty.

Pro­mo­some was cre­at­ed to com­mer­cial­ize the sci­en­tif­ic work of Ger­ald Edel­man and Vin­cent Mau­ro, both of whom were re­searchers at the Scripps Re­search In­sti­tute in San Diego. They — along with two oth­ers, Wei Zhou and Stephen Chap­pell — lat­er patent­ed a method for in­creas­ing mR­NA pro­tein ex­pres­sion, which was is­sued in 2014.

“The se­quence un­der­ly­ing de­fen­dants’ Covid-19 vac­cine tells a clear sto­ry: de­fen­dants used the method of the ’179 Patent in their Covid-19 vac­cine,” the suit al­leges.

The law­suit against Mod­er­na said that Pro­mo­some talked with Mod­er­na be­tween 2013 and 2016 about a po­ten­tial li­cens­ing and busi­ness part­ner­ship, with cur­rent Mod­er­na Pres­i­dent Stephen Hoge vis­it­ing Pro­mo­some’s fa­cil­i­ties at Scripps in 2013 to dis­cuss the biotech's IP.

Pro­mo­some’s suit al­so claims that the com­pa­ny sent a copy of the patent to Mod­er­na in 2016, and Mod­er­na’s now-head of busi­ness de­vel­op­ment, Said Fran­cis, said that Mod­er­na’s head of IP would re­view it.

The FDA will go ahead with a reg­u­lar ad­vi­so­ry com­mit­tee hear­ing process for bat­tered Intar­cia’s twice-year­ly type 2 di­a­betes drug, known as IT­CA 650, and it will be the agen­cy's way or the high­way, ac­cord­ing to a let­ter from the FDA re­spond­ing to re­quests from the com­pa­ny to change what the FDA says are "typ­i­cal" process­es.

The re­sponse from the FDA, writ­ing on be­half of the Cen­ter for Drug Eval­u­a­tion and Re­search (CDER), was a re­ply to a May 18 let­ter from lawyers for the com­pa­ny, ask­ing the agency to "de­vi­ate from its typ­i­cal process at every junc­ture.”

Since 2021, the com­pa­ny has all but shut down as ex­ec­u­tive team lead­ers left af­ter the FDA said in a Fed­er­al Reg­is­ter no­tice that the tri­al da­ta “demon­strat­ed that IT­CA 650 caus­es acute kid­ney in­jury.” But the com­pa­ny hasn’t giv­en up, con­tin­u­ing to hound the agency for meet­ings and a post-CRL hear­ing that is now an ad­comm de­spite mul­ti­ple re­jec­tions from the agency.

In Feb­ru­ary, Intar­cia sub­mit­ted a cit­i­zen pe­ti­tion for an al­ter­na­tive form of hear­ing. In March, ac­cord­ing to a let­ter from Bum­pus, the agency said it would grant the com­pa­ny an En­docrino­log­ic and Meta­bol­ic Drugs Ad­vi­so­ry Com­mit­tee in­stead of a for­mal ev­i­den­tiary hear­ing.

In a meet­ing in April, the agency said it would set up an ad­comm for the com­pa­ny "con­sis­tent with the typ­i­cal prac­tice for ad­vi­so­ry com­mit­tees," ac­cord­ing to the FDA's let­ter. But Intar­cia con­tin­ued to ask for changes to the process in May cor­re­spon­dence.

Phar­ma­ceu­ti­cal man­u­fac­tur­ing sites have been tak­ing root in Africa over the past year and Fo­s­un Phar­ma is look­ing to es­tab­lish a sig­nif­i­cant pro­duc­tion site on the con­ti­nent as well.

Fo­s­un Phar­ma an­nounced yes­ter­day that it is part­ner­ing with the World Bank's In­ter­na­tion­al Fi­nance Cor­po­ra­tion (IFC) to help Fo­s­un con­struct a phar­ma­ceu­ti­cal pro­duc­tion fa­cil­i­ty and dis­tri­b­u­tion cen­ter in the Ivory Coast.

The IFC will pro­vide Fo­s­un with two loans worth €100 mil­lion ($107.1 mil­lion), to sup­port the con­struc­tion of a man­u­fac­tur­ing fa­cil­i­ty near Abid­jan, Ivory Coast. Ac­cord­ing to a re­lease, the site plans to pro­duce an­ti-malar­ia and an­ti-bac­te­r­i­al drugs.

Fo­s­un’s build­out of the site will be in three stages and will have enough ca­pac­i­ty to pro­duce 5 bil­lion tablets an­nu­al­ly once it is com­plet­ed. How­ev­er, de­tails on the size of the fa­cil­i­ty or the head count were not im­me­di­ate­ly avail­able. End­points News reached out to both Fo­s­un and the IFC but did not re­ceive a re­sponse.

“Since 2006, IFC has re­peat­ed­ly pro­vid­ed sup­port to Fo­s­un Phar­ma, which is com­mit­ted to en­sur­ing the con­tin­u­ous ac­ces­si­bil­i­ty and af­ford­abil­i­ty of phar­ma­ceu­ti­cal prod­ucts and im­prov­ing the re­silience of health­care sup­ply chains in the re­gion,” Fo­s­un Phar­ma chair Yi­fang Wu said in a re­lease.

Fo­s­un has had deep ties in both Ivory Coast and the wider con­ti­nent. Its an­ti-malar­ia drug Arte­sun has been treat­ing a num­ber of pa­tients in Africa and has sup­plied an­ti­malar­i­al drugs to UNICEF, WHO, the Glob­al Fund and oth­er cus­tomers in Sub-Sa­ha­ran Africa. In 2021, Fo­s­un’s sub­sidiary, Tri­dem Phar­ma SAS, opened a re­gion­al dis­tri­b­u­tion hub in Abid­jan.

The new­ly launched coali­tion Rise to Health wants to un-si­lo health­care in­dus­try play­ers to work to­geth­er for eq­ui­ty — and that means phar­ma too.

Helmed by the Amer­i­can Med­ical As­so­ci­a­tion, the In­sti­tute for Health­care Im­prove­ment (IHI) and Race For­ward, the ini­tia­tive, for which Genen­tech is found­ing lead fun­der, is lean­ing on the phar­ma in­dus­try to do its part around is­sues like ac­cess and pric­ing. And it’s not just about hold­ing meet­ings and talk­ing about so­lu­tions.

“We’re re­al­ly fo­cused on chang­ing prac­tices,” said IHI pres­i­dent and CEO Kedar Mate. “It’s about get­ting to work, ask­ing lead­ers from phar­ma and biotech to com­mit to spe­cif­ic ac­tions that will help us change the sto­ry.”

Along with Genen­tech, the group is work­ing with Bris­tol My­ers Squibb and sev­er­al oth­er phar­ma­ceu­ti­cal com­pa­nies, he said, al­though it’s ad­mit­ted­ly still in the ear­ly stages com­pared to its work with health­care providers. Rise to Health of­fi­cial­ly launched last week, but the work and foun­da­tion-lay­ing be­gan two years ago.

One of the big chal­lenges Mate and the ini­tia­tive are tack­ling is to con­vince peo­ple in the in­dus­try that in­equities in health­care and sub­stan­dard out­comes aren’t just the way it is and will al­ways be in Amer­i­can health­care.

The Key­stone State is get­ting a new man­u­fac­tur­ing site for ma­te­ri­als used in phar­ma drug pro­duc­tion.

Puro­lite, a di­vi­sion of Eco­lab and a man­u­fac­tur­er of resins used in drugs, will be con­struct­ing a $190 mil­lion resin pro­duc­tion fa­cil­i­ty in the town of Lan­den­berg, PA, lo­cat­ed in Chester Coun­ty, around 45 miles south­east of Philadel­phia. Con­struc­tion plan­ning is cur­rent­ly un­der­way, ac­cord­ing to a re­lease from Puro­lite, with the new fa­cil­i­ty aim­ing to boost the sup­ply of resins for phar­ma and biotech cus­tomers. It will mark Puro­lite’s fourth lo­ca­tion in Penn­syl­va­nia.

While the size of the fa­cil­i­ty was not dis­closed, it will con­tain resin man­u­fac­tur­ing fa­cil­i­ties, lab­o­ra­to­ries, of­fice space and ad­di­tion­al land for fu­ture ex­pan­sion. Puro­lite al­so ex­pects to hire around 150 em­ploy­ees in the next five years.

“As Puro­lite con­tin­ues to grow, we are com­mit­ted to con­tin­ued chro­matog­ra­phy in­no­va­tion and ded­i­cat­ed ap­pli­ca­tions sup­port, thus im­prov­ing the glob­al sup­ply of the high-qual­i­ty prod­ucts to pro­duce life­sav­ing and life-en­hanc­ing ther­a­peu­tics,” Hay­ley Crowe, Puro­lite’s SVP and gen­er­al man­ag­er, said in a re­lease.

Ac­cord­ing to a re­lease from Penn­syl­va­nia Gov. Josh Shapiro's of­fice, Puro­lite re­ceived a pro­pos­al from the state's De­part­ment of Com­mu­ni­ty De­vel­op­ment for over $1 mil­lion. The man­u­fac­tur­er has al­so been en­cour­aged to ap­ply for oth­er fi­nan­cial as­sis­tance pro­grams from the state as well.

Gov. Shapiro’s of­fice said the first phase on con­struc­tion will be com­plet­ed by ear­ly 2025.

“These types of strate­gic in­vest­ments in grow­ing busi­ness­es are po­si­tion­ing the Com­mon­wealth as an eco­nom­ic pow­er­house, and we will con­tin­ue to make in­vest­ments that bring more ex­pan­sions and good-pay­ing jobs to the Com­mon­wealth,” Shapiro said in a re­lease.

Bio­phar­ma jobs con­tin­ue to be par­tic­u­lar­ly lu­cra­tive, with well over 100 life sci­ences com­pa­nies pay­ing their me­di­an em­ploy­ee more than $100,000 in 2022, ac­cord­ing to an End­points News analy­sis.

Af­ter re­view­ing hun­dreds of reg­u­la­to­ry fil­ings, End­points com­piled da­ta from 175 phar­ma­ceu­ti­cal, biotech, and life sci­ences com­pa­nies that dis­closed their me­di­an em­ploy­ee com­pen­sa­tion last year. While there are lim­i­ta­tions in com­par­ing fig­ures, they give a rare look at how much com­pa­nies pay work­ers.

Pay ranges vary wide­ly, de­pend­ing on the em­ploy­er: The best-pay­ing com­pa­ny on the list had a me­di­an salary of $674,500, while the bot­tom com­pa­ny paid $12,380. The mid-range was around $200,000.

High pay­checks are just an­oth­er in­di­ca­tor of the in­dus­try’s war for tal­ent, as well as the spe­cial­ized skills re­quired for many of the jobs. Bio­phar­ma ex­ec­u­tives have high­light­ed the chal­lenge of bring­ing in and keep­ing tal­ent­ed work­ers. The num­ber of life sci­ences re­searchers grew by 3.1% last year, out­pac­ing US job growth of 2.2%, ac­cord­ing to a June 6 re­port by the com­mer­cial re­al es­tate busi­ness CBRE Group. De­mand for life sci­ences work­ers is al­so high­er than pre-pan­dem­ic lev­els, the re­port found.

The pay da­ta sug­gest the coastal hubs of the in­dus­try are the front lines of the tal­ent war: 24 of the 27 com­pa­nies re­port­ing me­di­an pay over $300,000 are head­quar­tered in Cal­i­for­nia, Mass­a­chu­setts, or New York. Near­ly all of those were in the Boston, San Fran­cis­co and San Diego re­gions.

The top-pay­ing biotechs al­so tend to have small­er, high­ly spe­cial­ized teams. Among the top 10 com­pa­nies, for in­stance, three spe­cial­ize in neu­rol­o­gy (Anavex Life Sci­ences, Prothena, and Karuna Ther­a­peu­tics) and two are fo­cused on the liv­er dis­ease NASH (Akero Ther­a­peu­tics and Madri­gal Phar­ma­ceu­ti­cals). Twen­ty-six of the 27 com­pa­nies re­port­ing pay over $300,000 al­so had few­er than 1,000 em­ploy­ees.

Fi­bro­Gen's top an­ti­body can­di­date has failed a Phase III study in Duchenne mus­cu­lar dy­s­tro­phy, mark­ing a dis­ap­point­ing start to a string of read­outs slat­ed for the next few months.

Dubbed pam­revlum­ab, the drug is list­ed as a lead can­di­date for Fi­bro­Gen along­side rox­adu­s­tat — an ane­mia drug that's run in­to mul­ti­ple clin­i­cal and reg­u­la­to­ry set­backs of its own. Shares FGEN fell 9% to be­low $17 in pre-mar­ket trad­ing.

The LELAN­TOS-1 study is the first of two Phase III stud­ies in Duchenne to read out, and among a to­tal of five late-stage tri­als that Fi­bro­Gen has de­vised for pam­revlum­ab, which is de­signed to block a sig­nal­ing and reg­u­la­to­ry mol­e­cule called con­nec­tive tis­sue growth fac­tor.

LELAN­TOS-1 en­rolled non-am­bu­la­to­ry pa­tients with Duchenne who are re­ceiv­ing back­ground cor­ti­cos­teroids. It flunked the pri­ma­ry end­point, mea­sured by the Per­for­mance of the Up­per Limb 2.0 (PUL 2.0) score at week 52 com­pared to base­line.

The sec­ond study, LELAN­TOS-2, fo­cus­es on am­bu­la­to­ry pa­tients; da­ta are ex­pect­ed in the third quar­ter. Fi­bro­Gen did not im­me­di­ate­ly re­veal plans for the pro­gram, say­ing on­ly it will present the re­sults at a med­ical meet­ing.

“While dis­ap­point­ed with these re­sults, we look for­ward to shar­ing the da­ta at a fu­ture med­ical con­fer­ence to con­tribute to­wards the un­der­stand­ing of this dev­as­tat­ing dis­ease,” CEO En­rique Con­ter­no said in a state­ment.

Fi­bro­Gen is al­so test­ing pam­revlum­ab in id­io­path­ic pul­monary fi­bro­sis and lo­cal­ly ad­vanced un­re­sectable pan­cre­at­ic can­cer — and the drug re­ceived fast track and or­phan des­ig­na­tions for all three in­di­ca­tions from the FDA.