Hik­ma Phar­ma­ceu­ti­cals has promised to spend $1 bil­lion on grow­ing its US man­u­fac­tur­ing and R&D foot­print by 2030.

The drug­mak­er said its lat­est in­vest­ment — which it refers to as “Amer­i­ca Leans on Hik­ma” — will strength­en its port­fo­lio of more than 800 gener­ic med­i­cines and boost its ca­pac­i­ty to make large vol­umes of drugs, ac­cord­ing to a Sat­ur­day re­lease.

Hik­ma plans to fo­cus on ex­pand­ing its man­u­fac­tur­ing fa­cil­i­ties in Colum­bus and Cleve­land, OH, and Cher­ry Hill and Day­ton, NJ.

When Pres­i­dent Don­ald Trump start­ed talk­ing about tar­iffs ear­li­er this year, non­prof­its said gener­ic drug com­pa­nies would car­ry a lot of the bur­den since most of these prod­ucts are made out­side the US. Cer­tain com­pa­nies have said, though, they can with­stand tar­iff im­pact; most of their sales are made out­side the US and they have an ex­ist­ing pres­ence in the coun­try.

Uni­cy­cive Ther­a­peu­tics’ phos­phate binder drug has failed to se­cure FDA ap­proval for cer­tain chron­ic kid­ney dis­ease (CKD) pa­tients, mark­ing an­oth­er hitch in its goal to shift in­to a com­mer­cial-stage com­pa­ny.

The Los Al­tos, CA-based biotech said Mon­day the FDA re­ject­ed oxy­lan­thanum car­bon­ate as a treat­ment for ex­ces­sive lev­els of blood phos­phate in pa­tients re­ceiv­ing dial­y­sis. The agency is­sued a com­plete re­sponse let­ter cit­ing prob­lems at a third-par­ty man­u­fac­tur­er that were first iden­ti­fied and raised ear­li­er this month.

At the time, Uni­cy­cive clar­i­fied the is­sue was not with a drug sub­stance ven­dor, but one of its CD­MO’s third-par­ty con­trac­tors, and claimed it was work­ing to­wards a res­o­lu­tion. On Mon­day, the com­pa­ny said it has lined up an al­ter­na­tive man­u­fac­tur­ing ven­dor that has al­ready pro­duced the drug with the aim of ad­dress­ing the CRL as soon as pos­si­ble.

Ger­man oligonu­cleotide CD­MO BioSpring is ex­pand­ing its foot­print in its home coun­try, bud­get­ing over €100 mil­lion ($106 mil­lion) to build a new nu­cle­ic acid fac­to­ry in Of­fen­bach.

The 15,200-square-me­ter fa­cil­i­ty is sched­uled to be com­plet­ed by the end of 2027 and will add over 200 new jobs, the com­pa­ny told End­points News in an email.

The com­pa­ny will man­u­fac­ture API for RNA and DNA at that fac­to­ry. It will al­so house qual­i­ty con­trol of­fices, a sol­vent tank farm and an event venue, among oth­er spaces, the com­pa­ny said.

Head­quar­tered in Frank­furt, its lat­est build will be the com­pa­ny’s sec­ond fa­cil­i­ty in Ger­many, in ad­di­tion to its ex­ist­ing op­er­a­tional site in the coun­try. The CD­MO has a busi­ness de­vel­op­ment branch in San Diego, but there are no man­u­fac­tur­ing op­er­a­tions there.

It's been more than six years since the FDA found po­ten­tial­ly can­cer-caus­ing im­pu­ri­ties, known as ni­trosamines, in drugs to treat high blood pres­sure and heart fail­ure. And yet, the agency an­nounced this week that it's giv­ing com­pa­nies more time to re­port test­ing da­ta on their drugs.

In an up­date on its web­site, the agency said that while ap­pli­cants should con­clude con­fir­ma­to­ry test­ing for drugs at risk of ni­trosamine im­pu­ri­ties and sub­mit nec­es­sary changes to their ap­pli­ca­tions by Aug. 1, FDA "is al­low­ing ad­di­tion­al time for sub­mis­sion of re­quired changes" to re­move the im­pu­ri­ty, as mit­i­ga­tion "may vary de­pend­ing up­on the spe­cif­ic strat­e­gy, for ex­am­ple adding a spec­i­fi­ca­tion or re­for­mu­la­tion."

For ap­pli­cants that can­not meet the dead­line, FDA says com­pa­nies should sub­mit progress up­dates on com­plet­ing their ni­trosamine-re­lat­ed changes by Aug. 1.

Chi­na’s as­cent in drug de­vel­op­ment has kicked off de­bate among Amer­i­can in­vestors over how to re­spond.

Chi­nese com­pa­nies are now com­pet­i­tive in some of the hottest ar­eas of drug re­search, in­clud­ing obe­si­ty and can­cer. As a re­sult, phar­ma­ceu­ti­cal gi­ants are in­creas­ing­ly turn­ing to Chi­na for new med­i­cines, rather than US- or Eu­ro­pean-based biotechs.

The shift is pres­sur­ing US-based ven­ture cap­i­tal­ists, who typ­i­cal­ly re­ly heav­i­ly on phar­ma deals to dri­ve re­turn on their biotech in­vest­ments. In re­sponse, a di­vi­sion is form­ing: Should in­vestors re­sist Chi­na’s rise, or try to prof­it off it?

Zach Wein­berg, the CEO of the com­pa­ny Curie.Bio that in­vests in ear­ly-stage biotechs, plans to seek ex­ec­u­tive ac­tion from the Trump ad­min­is­tra­tion that would dis­cour­age US-Chi­na deals. His po­si­tion is the clear­est in­stance of a ven­ture cap­i­tal­ist pub­licly urg­ing Wash­ing­ton to clamp down on Chi­na’s grow­ing role in drug de­vel­op­ment.