HHS Sec­re­tary Robert F. Kennedy, Jr. re­peat­ed claims Mon­day that the threat of tar­iffs and Pres­i­dent Don­ald Trump's "per­son­al in­ter­ven­tion" have pushed Eu­ro­pean coun­tries to raise drug prices. While that's not backed up by any cur­rent Eu­ro­pean-wide da­ta, phar­ma ex­ecs are ex­pect­ing prices to rise there.

"The Eu­ro­peans were very good at ne­go­ti­at­ing," Kennedy said in re­marks to the right-lean­ing non­prof­it Her­itage Foun­da­tion. He said Trump called him and CMS Ad­min­is­tra­tor Mehmet Oz — some­times in the mid­dle of the night and "al­most an­gry" — to get the so-called most fa­vored na­tion deals done and to use "tar­iffs to force the Eu­ro­peans to raise their drug prices."

The FDA has re­ject­ed Re­genxbio’s gene ther­a­py for a se­ri­ous in­her­it­ed dis­ease called Hunter syn­drome in a de­ci­sion that could re­ver­ber­ate to oth­er rare dis­ease drug­mak­ers as well.

The com­plete re­sponse let­ter comes short­ly af­ter the FDA sus­pend­ed a clin­i­cal tri­al for RGX-121, af­ter a pa­tient who re­ceived an­oth­er Re­genxbio gene ther­a­py for a dif­fer­ent con­di­tion was found to have a brain tu­mor.

The agency raised a num­ber of is­sues re­lat­ed to the study de­sign for not ap­prov­ing the ther­a­py, but did not cite safe­ty con­cerns as one of those rea­sons, Re­genxbio told End­points News. One of the key is­sues raised by the FDA was the "ap­pro­pri­ate­ness" of the bio­mark­er that Re­genxbio and oth­er drug­mak­ers have used as the pri­ma­ry end­point in their clin­i­cal tri­als.

A Chi­na-Amer­i­can biotech has raised a new round led by the VC arms of two large drug­mak­ers, ad­vanc­ing a pipeline go­ing af­ter some pop­u­lar im­munol­o­gy tar­gets.

Quan­tX Bio­sciences said Mon­day it has raised an $85 mil­lion Se­ries B round that will bring its lead pro­grams — small mol­e­cules re­spec­tive­ly tar­get­ing STAT6 and IL-17 — in­to the clin­ic. In­cu­bat­ed by Or­biMed and Crea­cion Ven­tures, Quan­tX said its Se­ries B was co-led by LAV, or Lil­ly Asia Ven­tures, and Sanofi Ven­tures.

Quan­tX was co-found­ed in 2022 by its CTO Yax Sun, Am­gen’s for­mer com­pu­ta­tion­al chem­istry head, and CSO Wayne Tang, a for­mer chemist at Mer­ck and Schro­ding­er. In an emailed state­ment, Tang said Quan­tX has about 30 em­ploy­ees, with a ma­jor­i­ty in the US and on­ly a cou­ple in Chi­na. While it has of­fice space in Prince­ton, NJ, it re­lies on ex­ter­nal part­ners for all lab­o­ra­to­ry work, in­clud­ing by "ex­ten­sive­ly” part­ner­ing in Chi­na.

No­vo Nordisk on Mon­day said it is su­ing tele­health com­pa­ny Hims & Hers for al­leged­ly in­fring­ing its patent on the weight loss med­ica­tion semaglu­tide — not just for the pill ver­sion, but for the in­jectable form as well.

The move comes af­ter Hims said on Thurs­day it would launch a com­pound­ed ver­sion of the Dan­ish drug­mak­er's obe­si­ty pill We­govy, be­fore re­vers­ing course on Sat­ur­day.

No­vo’s law­suit seeks to stop Hims from sell­ing the com­pound­ed shots of semaglu­tide, and if the case is suc­cess­ful, it could have seis­mic reper­cus­sions for No­vo’s — and Hims’ — top lines. Even if Hims has stepped back on the GLP-1 pills, it is still sell­ing com­pound­ed ver­sions of in­ject­ed semaglu­tide, which is sold by No­vo in the US as Ozem­pic for di­a­betes and We­govy for obe­si­ty.

Roche on Sat­ur­day de­tailed just how much its BTK in­hibitor was deemed non-in­fe­ri­or com­pared to its block­buster med­i­cine Ocre­vus in a late-stage tri­al in pri­ma­ry pro­gres­sive mul­ti­ple scle­ro­sis.

Fene­bru­ti­nib cut the risk of dis­abil­i­ty pro­gres­sion by 12% ver­sus the CD20-tar­get­ing an­ti­body Ocre­vus in the Phase 3 tri­al called FEN­tre­pid. The num­ber in­di­cates a “nom­i­nal trend to­ward bet­ter ef­fi­ca­cy, but the lev­el is mod­est,” Jef­feries an­a­lysts wrote in a Sun­day note.

Roche said in No­vem­ber that fene­bru­ti­nib met the tri­al’s pri­ma­ry end­point of non-in­fe­ri­or­i­ty to Ocre­vus in slow­ing dis­abil­i­ty pro­gres­sion, but it didn’t share de­tails at the time. The Sat­ur­day da­ta were pre­sent­ed at the Amer­i­c­as Com­mit­tee for Treat­ment and Re­search in Mul­ti­ple Scle­ro­sis fo­rum in San Diego.