When Jake Van Naar­den vis­its a hos­pi­tal run­ning clin­i­cal tri­als, he runs in­to an odd sight.

Van Naar­den, the head of Eli Lil­ly's on­col­o­gy unit, opens a sup­ply clos­et and sees more than a dozen EKG ma­chines stacked on shelves. They’re es­sen­tial­ly iden­ti­cal. But they’re all la­beled with the names of dif­fer­ent drug com­pa­nies.

“They’re ba­si­cal­ly all the same ma­chines,” Van Naar­den said. “But some of them were sent by Lil­ly for the Lil­ly stud­ies, and some of them were sent by No­var­tis for the No­var­tis stud­ies. You look at this and are like, ‘What is go­ing on here?’”

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, as he signed the "refuse to file" let­ter, which 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 News.

Madri­gal Phar­ma­ceu­ti­cals is on a mis­sion to be­come a gen­er­a­tional, in­de­pen­dent play­er in the MASH field with its third deal in eight months.

The first FDA-ap­proved med­i­cine for the fat­ty liv­er dis­ease, Rezd­if­fra, has now been on the mar­ket for 22 months. And the Penn­syl­va­nia biotech is rapid­ly ex­pand­ing its pipeline with next-gen­er­a­tion can­di­dates.

The lat­est move sees Madri­gal re­turn to Chi­na for an­oth­er pre­clin­i­cal pact. The drug­mak­er said it will dish out $60 mil­lion up­front to Suzhou Ri­bo Life Sci­ence for ac­cess to six siR­NA can­di­dates. The deal could rise to up to $4.4 bil­lion in biobucks, if the gene si­lenc­ing pro­grams come to fruition and hit cer­tain bench­marks.

With patent pro­tec­tion on Rezd­if­fra out to 2045, Madri­gal can place bets on an ar­ray of pre­clin­i­cal pro­grams, CEO Bill Si­bold said in an in­ter­view with End­points News short­ly af­ter Wednes­day's deal an­nounce­ment.