The FDA is still re­view­ing a la­bel ex­pan­sion for GSK’s res­pi­ra­to­ry drug Nu­cala in chron­ic ob­struc­tive pul­monary dis­ease de­spite the May 7 tar­get date for a de­ci­sion, the com­pa­ny con­firmed to End­points News.

“The FDA con­tin­ues to re­view our sub­mis­sion for Nu­cala in COPD and we are work­ing close­ly with them to en­sure we can bring this im­por­tant treat­ment op­tion to pa­tients as quick­ly as pos­si­ble,” a GSK spokesper­son said.

The spokesper­son said that “based on our lat­est dis­cus­sions with the FDA, we con­tin­ue to ex­pect ap­proval.” When asked for fur­ther de­tail on the FDA’s com­mu­ni­ca­tions, they said the agency is “ac­tive­ly re­view­ing our sub­mis­sion,” and “we do not com­ment on on­go­ing dis­cus­sions with reg­u­la­to­ry au­thor­i­ties.”

As­traZeneca lost its chal­lenge to Medicare drug price ne­go­ti­a­tions in the first ap­peals court rul­ing on the mer­its of the Biden-era pro­gram.

The de­ci­sion, is­sued Thurs­day by the US Court of Ap­peals for the Third Cir­cuit, is an­oth­er blow to the phar­ma­ceu­ti­cal in­dus­try, which has so far lost near­ly every case against the In­fla­tion Re­duc­tion Act’s drug pric­ing pro­vi­sions. It al­so helps to so­lid­i­fy the le­gal­i­ty of the ne­go­ti­a­tion pro­gram as it cur­rent­ly ex­ists. At least nine oth­er cas­es are work­ing their way through the courts.

“It’s a big deal for the ad­min­is­tra­tion and the long-term vi­a­bil­i­ty of the pro­gram,” Zachary Baron, di­rec­tor of the Health Pol­i­cy and the Law Ini­tia­tive at George­town Uni­ver­si­ty’s O’Neill In­sti­tute, told End­points News. It’s no­table that the three-judge pan­el came to a “fair­ly straight­for­ward opin­ion” re­ject­ing the com­pa­ny’s claims, he said.

Take­da re­vealed a hand­ful of pipeline cuts in its fourth-quar­ter earn­ings re­sults on Thurs­day, as the com­pa­ny fo­cus­es its at­ten­tion on six late-stage pro­grams it says could de­liv­er bil­lions of dol­lars in sales.

The cuts in­clude Phase 2 pro­grams for za­maglute­nase (al­so known as TAK-062) in celi­ac dis­ease, TAK-186 in EGFR-ex­press­ing sol­id tu­mors and da­zosti­nag (al­so known as TAK-676) in sol­id tu­mors, as well as a Phase 1 pro­gram for TAK-280 in B7-H3 ex­press­ing sol­id tu­mors, ac­cord­ing to Take­da’s lat­est quar­ter­ly re­port.

When asked for clar­i­ty on why the cuts were made, a Take­da spokesper­son told End­points News “we con­tin­ue to make da­ta-dri­ven de­ci­sions to main­tain fo­cus on our most promis­ing pipeline pro­grams.”

Il­lu­mi­na es­ti­mates about $85 mil­lion in costs this year re­lat­ed to tar­iffs on its DNA se­quenc­ing prod­ucts, the com­pa­ny said dur­ing its Thurs­day quar­ter­ly earn­ings re­port.

In ad­di­tion, the com­pa­ny ex­pects Chi­na sales of $165 mil­lion to $185 mil­lion in 2025, down from $308 mil­lion the pri­or year, fol­low­ing the Chi­nese gov­ern­ment ban­ning the sale of its DNA se­quencers in March. The ban does­n't stop Il­lu­mi­na from sell­ing tech­nol­o­gy like reagents, an in­te­gral part of the DNA se­quenc­ing process.

The geopo­lit­i­cal en­vi­ron­ment con­tributed to Il­lu­mi­na low­er­ing its sales guid­ance. The com­pa­ny now ex­pects rev­enue to de­cline 1% to 3% this year, ver­sus the low sin­gle-dig­it growth that pre­vi­ous­ly had been fore­cast.

“Our out­look for the year has weak­ened due to shift­ing pol­i­cy and geopo­lit­i­cal de­vel­op­ments and we have tak­en swift in­cre­men­tal ac­tions to pro­tect our earn­ings," CEO Ja­cob Thay­sen said in a news re­lease.

Boston-based Ve­rastem On­col­o­gy on Thurs­day won ac­cel­er­at­ed ap­proval from the FDA for Avmap­ki Fakzyn­ja as a sec­ond-lin