Vinay Prasad, di­rec­tor of the FDA's of­fice of bi­o­log­ics and vac­cines, over­ruled both the vac­cine re­view team and the head of the FDA's vac­cine team as part of the reg­u­la­tor's re­fusal to re­view Mod­er­na's flu vac­cine ap­pli­ca­tion, a source with di­rect knowl­edge of the ap­pli­ca­tion told End­points News.

The de­ci­sion not to re­view Mod­er­na's mR­NA-based flu vac­cine came to light on Tues­day, af­ter the biotech is­sued a con­tentious news re­lease say­ing that the agency had shift­ed the re­quire­ments for the vac­cine tri­al.

There were ear­li­er hints that Prasad may have act­ed uni­lat­er­al­ly, sign­ing the refuse-to-file let­ter that is usu­al­ly signed by pro­fes­sion­al staff. A cen­ter di­rec­tor step­ping in can be a sign of dis­agree­ment be­tween FDA lead­er­ship and staff be­low them. Prasad's over­rule was con­firmed ear­li­er Wednes­day by STAT.

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 tele­health com­pa­ny Hims & Hers said it will no longer sell a com­pound­ed ver­sion of No­vo Nordisk's We­govy pill, just days af­ter an­nounc­ing the new prod­uct.

The move comes af­ter No­vo, which launched its brand-name weight loss pill just last month, said it would take le­gal ac­tion, and US gov­ern­ment health agen­cies threat­ened to take "de­ci­sive steps" against the com­pa­ny.

"Since launch­ing the com­pound­ed semaglu­tide pill on our plat­form, we’ve had con­struc­tive con­ver­sa­tions with stake­hold­ers across the in­dus­try," Hims said in a state­ment post­ed on­line. "As a re­sult, we have de­cid­ed to stop of­fer­ing ac­cess to this treat­ment."

Hims did­n't say if it plans to make changes to its busi­ness sell­ing com­pound­ed in­jectable semaglu­tide, and HHS did­n't say if it would con­tin­ue to pur­sue ac­tion against Hims now that it is pulling back from its plans for the com­pound­ed pill.

The FDA can con­tin­ue to grant sev­en years of ex­clu­siv­i­ty for or­phan drugs with new in­di­ca­tions, as Pres­i­dent Don­ald Trump this week signed a gov­ern­ment fund­ing ex­ten­sion that in­clud­ed a pro­vi­sion that cod­i­fies that process and runs counter to a 2021 ap­peals court de­ci­sion against the agency.

The al­ter­ation on or­phan ex­clu­siv­i­ty in the spend­ing pack­age, which the FDA had been lob­by­ing Con­gress to fix since at least 2022, means the agency can still ap­prove drugs for nar­row­er us­es or in­di­ca­tions even if a com­peti­tor has an ap­proved drug for the same dis­ease.

While the agency an­nounced that it would­n't change its or­phan des­ig­na­tion process in Jan­u­ary 2023, the move ran counter to what the US Court of Ap­peals for the Eleventh Cir­cuit told the FDA in 2021. The de­ci­sion said the agency shouldn’t have ap­proved two drugs for the same dis­ease when one had ex­clu­siv­i­ty, even if the two were geared to­ward dif­fer­ent pa­tient pop­u­la­tions.

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, when 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.

The Na­tion­al In­sti­tutes of Health has halt­ed an arm of a large tri­al in­ves­ti­gat­ing whether J&J and Bay­er's blood thin­ner Xarel­to is su­pe­ri­or to the stan­dard of care for low­er­ing the rate of stroke or vas­cu­lar death over one year.

NIH said Tues­day that the halt was due to safe­ty con­cerns. It said the study found low-dose Xarel­to to be "un­safe and in­ef­fec­tive com­pared to stan­dard of care," which is Sanofi and Bris­tol My­ers Squib­b's Plav­ix. The de­ci­sion fol­lowed a reg­u­lar re­view by the study's Da­ta Safe­ty and Mon­i­tor­ing Board, ac­cord­ing to NIH.

The study, known as