New da­ta from Ire­land’s Cen­tral Sta­tis­tics Of­fice sug­gest that phar­ma­ceu­ti­cal com­pa­nies are ex­port­ing more in­ven­to­ry to the US as the threat of drug tar­iffs per­sists.

Med­ical and phar­ma­ceu­ti­cal prod­uct ex­ports from Ire­land in­creased by 73.9% in May com­pared to the same month last year, reach­ing a to­tal of €13.7 bil­lion ($15.9 bil­lion), ac­cord­ing to trade da­ta pub­lished Thurs­day morn­ing.

Ex­ports to the US from Ire­land in­creased by around 86.5% com­pared to May 2024, ac­cord­ing to the da­ta.

The mass ex­o­dus of phar­ma prod­ucts from Ire­land re­flects an in­crease com­pared to the month pri­or, which reached a to­tal of €10.9 bil­lion ($12.6 bil­lion). Phar­ma ex­ports had re­turned large­ly to nor­mal in April af­ter a pre­vi­ous surge in March.

Pres­i­dent Don­ald Trump has hint­ed that phar­ma-spe­cif­ic tar­iffs could be ar­riv­ing as soon as “the end of the month.”

In its next move to boost the life sci­ences in­dus­try, the UK gov­ern­ment is ear­mark­ing at least £250 mil­lion ($335 mil­lion) to help build a new re­search and de­vel­op­ment site called the Na­tion­al Biose­cu­ri­ty Cen­tre in Har­low, Es­sex.

The cen­ter, lo­cat­ed just over an hour's dri­ve from Lon­don, will be used to de­vel­op ther­a­pies and vac­cines to pre­pare for fu­ture pan­demics, and it aims to be the largest of its kind in Eu­rope, ac­cord­ing to the Thurs­day press re­lease.

The gov­ern­ment said it will even­tu­al­ly in­vest “bil­lions of pounds” in­to the project, which will be­gin as soon as pos­si­ble. The ex­act amount of fund­ing for the Cen­tre will be an­nounced at a lat­er date.

Dae­woo Phar­ma­ceu­ti­cal has re­ceived a warn­ing let­ter from the FDA over the po­ten­tial con­t­a­m­i­na­tion of a sub­stance known to cause lethal poi­son­ings at its Bu­san, South Ko­rea, man­u­fac­tur­ing site.

The let­ter, pub­lished this week and dat­ed Ju­ly 2, out­lines five is­sues un­cov­ered at the site dur­ing an FDA in­spec­tion be­tween Jan. 6 and Jan. 15. The Bu­san-head­quar­tered drug­mak­er has sus­pend­ed all man­u­fac­tur­ing at the site and dereg­is­tered the fac­to­ry as a man­u­fac­tur­er with the FDA, ac­cord­ing to the let­ter. Dae­woo spe­cial­izes in mak­ing oph­thalmic over-the-counter drugs for the US mar­ket.

One key prob­lem the agency out­lined was the site’s qual­i­ty con­trol unit, which the FDA says did not prop­er­ly sam­ple and test im­port­ed raw ma­te­ri­als to see if they in­clud­ed an un­named sub­stance that can cause lethal poi­son­ings if con­t­a­m­i­nat­ed. Fin­ished prod­ucts pre­vi­ous­ly made us­ing these raw ma­te­ri­als were not prop­er­ly test­ed.

A re­cent drug re­call of Pfiz­er’s peni­cillin prod­uct has put the im­me­di­ate sup­ply of a key syphilis treat­ment at risk, ac­cord­ing to the com­pa­ny and a coali­tion of pub­lic health of­fi­cials ad­dress­ing sex­u­al­ly trans­mit­ted dis­eases.

Pfiz­er dis­closed the re­call of Bi­cillin to cus­tomers on Ju­ly 10, de­tail­ing in its alert that it was “due to par­tic­u­lates iden­ti­fied dur­ing vi­su­al in­spec­tion.” A haz­ard as­sess­ment con­duct­ed by the com­pa­ny put the risk to pa­tients as “medi­um.”

A Pfiz­er spokesper­son said that to date, it has not re­ceived any re­ports of ad­verse events. The re­call was at­trib­uted to “stop­pers sup­plied from an ex­ter­nal ven­dor,” and the com­pa­ny is work­ing to re­solve the is­sue.

The FDA hit Ul­tragenyx with a com­plete re­sponse let­ter for its AAV gene ther­a­py, called UX111, over man­u­fac­tur­ing is­sues. How­ev­er, the com­pa­ny be­lieves those is­sues can be solved and that the ther­a­py can be ap­proved next year.

The FDA's com­plaints stemmed from a "re­cent­ly com­plet­ed" man­u­fac­tur­ing in­spec­tion, the com­pa­ny said in a re­lease late Fri­day.

"The com­pa­ny be­lieves that these ob­ser­va­tions are read­i­ly ad­dress­able, re­lat­ed to fa­cil­i­ties and process­es, and are not di­rect­ly re­lat­ed to the qual­i­ty of the prod­uct," Ul­tragenyx said Fri­day. It plans to work with the FDA, re­sub­mit, and ex­pects a six-month re­view af­ter that.

UX111 is a treat­ment for pa­tients with San­fil­ip­po syn­drome type A, a neu­rode­gen­er­a­tive child­hood con­di­tion for which there is no ap­proved ther­a­py. The FDA "did not note any re­view is­sues re­lat­ed to the clin­i­cal da­ta pack­age nor clin­i­cal in­spec­tions," the com­pa­ny said.

Capri­cor Ther­a­peu­tics said on Fri­day it re­ceived a Com­plete Re­sponse Let­ter from the FDA for its lead cell ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy (DMD), cit­ing the agency was not sat­is­fied with its clin­i­cal da­ta and cer­tain man­u­fac­tur­ing com­mit­ments.

The agency cit­ed a lack of clin­i­cal da­ta show­ing the ef­fec­tive­ness of the cell ther­a­py, named de­ramio­cel, and has re­quest­ed fur­ther in­for­ma­tion, ac­cord­ing to a re­lease. Capri­cor’s BLA was sup­port­ed by da­ta from its Phase 2 tri­al called HOPE-2, which in­ves­ti­gat­ed the cell ther­a­py in 20 pa­tients with DMD. Those mid-stage da­ta showed clin­i­cal­ly mean­ing­ful preser­va­tion of heart func­tion over four years com­pared to a place­bo.