FDA Com­mis­sion­er Mar­ty Makary un­veiled the first nine com­pa­nies to win his new Na­tion­al Pri­or­i­ty Vouch­ers, a big­ger co­hort than orig­i­nal­ly planned as part of the agency’s ef­fort to sig­nif­i­cant­ly cut some drug re­view times.

The vouch­er pro­gram aims to re­view se­lect­ed drugs in as lit­tle as one month af­ter sub­mis­sion, in­stead of the typ­i­cal 10 to 12-month time­line. When it was first an­nounced in June, the FDA said up to five com­pa­nies would par­tic­i­pate in the first year, ac­cord­ing to a web­page screen­shot from Ju­ly.

That lan­guage has since been re­moved from the FDA’s site. Makary has vowed to re­lease even more vouch­ers in the com­ing weeks, align­ing with Pres­i­dent Don­ald Trump’s pri­or­i­ties for low­er­ing drug prices and in­creas­ing US man­u­fac­tur­ing.

The Eu­ro­pean Med­i­cines Agen­cy's hu­man med­i­cines com­mit­tee (CHMP) re­ject­ed Sanofi’s Rezurock af­ter a clin­i­cal tri­al was cut short be­cause it showed no ben­e­fits in pa­tients.

Rezurock, which is avail­able in the US for the treat­ment of chron­ic graft-ver­sus-host dis­ease af­ter oth­er ther­a­pies, failed to gain fa­vor with Eu­ro­pean reg­u­la­tors over is­sues in the drug’s clin­i­cal tri­al da­ta, ac­cord­ing to the Fri­day press re­lease. CHMP said it was dif­fi­cult to quan­ti­fy the ef­fect of the ther­a­py in pa­tients who had tried oth­er treat­ments, and that the main clin­i­cal tri­al sup­port­ing its re­view did not com­pare Rezurock to oth­er drugs.

→ Boehringer In­gel­heim has pro­mot­ed Vani Man­ja to glob­al head of the obe­si­ty and liv­er health ther­a­peu­tic area, ac­cord­ing to her LinkedIn. Man­ja came to Boehringer from medtech gi­ant BD in 2011 and had been coun­try man­ag­ing di­rec­tor and head of hu­man phar­ma for the UK & Ire­land for the past two and a half years. Boehringer and Zealand Phar­ma are in Phase 3 tri­als with its glucagon re­cep­tor/GLP-1 re­cep­tor dual ag­o­nist sur­vo­du­tide in MASH and obe­si­ty. Boehringer al­so has an obe­si­ty pact with Dan­ish biotech Gubra. “This new­ly es­tab­lished ther­a­peu­tic area re­flects our grow­ing com­mit­ment to tack­ling some of the most press­ing health chal­lenges of our time and re­in­forces our fo­cus on ad­vanc­ing in­no­va­tion and de­liv­er­ing mean­ing­ful im­pact in ar­eas of sig­nif­i­cant med­ical need,” Man­ja wrote.

Roche is spend­ing $80 mil­lion up­front for glob­al rights to Han­soh Phar­ma’s col­orec­tal can­cer can­di­date, which is an ear­ly-stage ADC that tar­gets the CDH17 pro­tein.

Han­soh could get up to $1.45 bil­lion in mile­stones, as well as tiered roy­al­ties on fu­ture sales, ac­cord­ing to a Fri­day re­lease. The Chi­nese biotech’s as­set, called HS-20110, is in Phase 1 de­vel­op­ment in the US and Chi­na for col­orec­tal can­cer and oth­er sol­id tu­mors.

The deal does not in­clude the rights to the pro­gram in main­land Chi­na, Hong Kong, Macau and Tai­wan.

Roche al­ready has a pres­ence in the col­orec­tal can­cer mar­ket through its an­ti-VEGF drug Avastin, which is ap­proved for metasta­t­ic dis­ease. Al­so, ear­li­er this year, a Phase 3 study sup­port­ed by the Na­tion­al Can­cer In­sti­tute showed that Roche’s PD-L1 in­hibitor Tecen­triq plus chemother­a­py sig­nif­i­cant­ly im­proved dis­ease-free sur­vival in cer­tain pa­tients with stage 3 colon can­cer. Tecen­triq is not cur­rent­ly ap­proved for col­orec­tal can­cer.

Rani Ther­a­peu­tics is pair­ing its oral de­liv­ery sys­tem with Chugai’s ex­per­i­men­tal rare dis­ease an­ti­body as part of a deal worth up to $1.08 bil­lion.

San Jose, CA-based Rani al­so dis­closed a $60.3 mil­lion pri­vate place­ment led by Sam­sara Bio­Cap­i­tal. Its stock price RANI took off and was up by as much as 250% on Fri­day morn­ing.

In the deal with Chugai, Rani gets $10 mil­lion up­front, up to $75 mil­lion in “tech­nol­o­gy trans­fer” and de­vel­op­ment mile­stones, and up to $100 mil­lion in sales mile­stones, plus sin­gle-dig­it roy­al­ties.

The agree­ment al­so gives the Tokyo drug­mak­er the rights to part­ner with Rani on up to five ad­di­tion­al drug tar­gets. That takes the deal’s po­ten­tial to­tal to $1.08 bil­lion.