The FDA on Thurs­day launched a new pro­gram that aims to boost do­mes­tic drug man­u­fac­tur­ing by mak­ing it eas­i­er for com­pa­nies to build fac­to­ries in the US.

The pro­gram, dubbed FDA PreCheck, is the lat­est ef­fort by the Trump ad­min­is­tra­tion to in­crease US drug pro­duc­tion. Pres­i­dent Don­ald Trump has warned that phar­ma-spe­cif­ic tar­iffs could be ar­riv­ing in the "next week or so" in a bid to en­cour­age com­pa­nies to shift their man­u­fac­tur­ing pres­ence.

"FDA PreCheck aims to sup­port faster es­tab­lish­ment of new US phar­ma­ceu­ti­cal man­u­fac­tur­ing ca­pac­i­ty through ear­li­er reg­u­la­to­ry in­put, en­hanced en­gage­ment, and ef­fi­cient CMC as­sess­ments," ac­cord­ing to a no­tice in the Fed­er­al Reg­is­ter.

Pres­i­dent Don­ald Trump said phar­ma­ceu­ti­cal tar­iffs will be an­nounced as soon as next week and could reach up to 250% af­ter the next year and a half.

"We'll be putting ini­tial­ly a small tar­iff on phar­ma­ceu­ti­cals. But in one year, one and a half years max­i­mum, it's gonna go to 150% and then it's gonna go to 250%, be­cause we want phar­ma­ceu­ti­cals made in our coun­try," Trump said Tues­day on CN­BC.

He said the sec­tor-spe­cif­ic tar­iffs will be com­ing “in the next week or so.”

Trump has been teas­ing tar­iffs on phar­ma im­ports for months. His lat­est com­ments hint that the Sec­tion 232 in­ves­ti­ga­tion in­to the phar­ma­ceu­ti­cal sec­tor, which be­gan in April, may be near­ing its end. In­dus­try heavy hit­ters No­vo Nordisk, Ab­b­Vie, Am­gen, Vi­a­tris and Pfiz­er, in pub­lic com­ments on the in­ves­ti­ga­tion, have all urged the gov­ern­ment against im­pos­ing phar­ma tar­iffs.

As Pres­i­dent Don­ald Trump con­tin­ues to threat­en phar­ma tar­iffs, Ire­land has on­ly seen one new for­eign di­rect in­vest­ment (FDI) from bio­phar­ma com­pa­nies so far this year as they start to re­lo­cate fu­ture man­u­fac­tur­ing builds and ex­pan­sions to the US.

Ire­land has been a hub for drug man­u­fac­tur­ing for decades, es­pe­cial­ly for mak­ing and sup­ply­ing raw ma­te­ri­als and API, Ro­ry Mullen, head of bio­phar­ma and food at IDA Ire­land, said in an in­ter­view with End­points News.

But now, bio­phar­ma com­pa­nies that are start­ing their in­vest­ment projects in Ire­land, whether that’s an R&D or man­u­fac­tur­ing site, are paus­ing their plans, Mullen said. “Peo­ple are wait­ing for some sort of clar­i­ty on what the glob­al trade en­vi­ron­ment is go­ing to be like go­ing for­ward,” he added.

Schol­ar Rock is not an­tic­i­pat­ing any de­lays to the PDU­FA date for its lead as­set apite­gromab in spinal mus­cu­lar at­ro­phy, de­spite is­sues found at two third-par­ty CD­MO sites, with one of these run by No­vo Nordisk.

“We're dis­ap­point­ed, but we weren't sur­prised to learn that two of our sites re­ceived ob­ser­va­tions,” CEO David Hal­lal said on a Wednes­day earn­ings call. “The ben­e­fit for us is that those ob­ser­va­tions were pre­sent­ed well with­in our re­view cy­cle that al­low for a re­sponse and ob­vi­ous­ly a green light,” Hal­lal added, ac­cord­ing to an Al­phaSense tran­script.

The “tone and tenor” of Schol­ar's con­ver­sa­tions with the FDA makes the com­pa­ny con­fi­dent that the mon­o­clon­al an­ti­body’s PDU­FA date of Sept. 22 won't be de­layed, Hal­lal said.

Re­gen­eron's bis­pe­cif­ic an­ti­body has been re­ject­ed a third time, and the drug­mak­er ex­pects de­lays to oth­er pend­ing FDA ap­provals for Eylea HD, it said dur­ing a sec­ond-quar­ter earn­ings an­nounce­ment Fri­day.

The FDA is­sued a com­plete re­sponse let­ter for odronex­tam­ab in fol­lic­u­lar lym­phoma, Re­gen­eron said. The agency pre­vi­ous­ly gave a thumbs-down to the CD20xCD3 bis­pe­cif­ic in March 2024 over the "en­roll­ment sta­tus of con­fir­ma­to­ry tri­als." The com­pa­ny went back and sought ac­cel­er­at­ed ap­proval in­stead.

And now, Re­gen­eron said the reg­u­la­tor gave an­oth­er no-go on Ju­ly 30 due to is­sues at a for­mer Catal­ent site in In­di­ana. The site is now owned by No­vo Nordisk.

Eli Lil­ly is sell­ing its Branch­burg, NJ man­u­fac­tur­ing fa­cil­i­ty as it shifts ca­pac­i­ty away from mon­o­clon­al an­ti­bod­ies and to­ward more com­plex forms of bi­o­log­ics, the drug­mak­er told End­points News.

The In­di­anapo­lis-based phar­ma is en­ter­ing in­to late-stage talks with one buy­er and hopes to close a sale by the end of this year, said Edgar­do Her­nan­dez, pres­i­dent of Lil­ly's man­u­fac­tur­ing op­er­a­tions. It's look­ing for a buy­er who is will­ing to take on the work­force at the fa­cil­i­t