No­var­tis is now the sixth drug­mak­er to bring its In­fla­tion Re­duc­tion Act chal­lenge to the Supreme Court as the phar­ma in­dus­try’s years­long court bat­tle comes to a head.

No­var­tis was the last drug­mak­er ex­pect­ed to file a pe­ti­tion, at least for now. A de­ci­sion to take any of the cas­es could give the jus­tices a chance to shed light on the con­sti­tu­tion­al­i­ty of the ne­go­ti­a­tion pro­gram, or on how the gov­ern­ment can ne­go­ti­ate drug prices un­der the law.

A No­var­tis spokesper­son told End­points News that the com­pa­ny filed its pe­ti­tion on Fri­day. The pe­ti­tion wasn’t im­me­di­ate­ly avail­able. CMS ne­go­ti­at­ed a 53% dis­count from the list price of No­var­tis’ heart drug En­tresto.

As­traZeneca, Bris­tol My­ers Squibb, John­son & John­son, No­vo Nordisk and Boehringer In­gel­heim have al­so filed pe­ti­tions.

Catal­ent plans to close a cell ther­a­py site in Gos­selies, Bel­gium, due to “chang­ing mar­ket dy­nam­ics and cus­tomer needs,” a com­pa­ny spokesper­son con­firmed to End­points News. 

The con­tract de­vel­op­er and man­u­fac­tur­er is con­sid­er­ing tran­si­tion­ing some “on­go­ing busi­ness” from Gos­selies to oth­er fa­cil­i­ties in its net­work, the spokesper­son said. The site cur­rent­ly em­ploys about 150 work­ers, and the spokesper­son did­n't con­firm whether they will be laid off or trans­ferred to an­oth­er Catal­ent lo­ca­tion.

The Gos­selies site hous­es three fa­cil­i­ties for cell ther­a­py and plas­mid man­u­fac­tur­ing: a 60,000-square-foot fac­to­ry for com­mer­cial pro­duc­tion, a 41,000-square-foot plant for clin­i­cal and com­mer­cial sup­ply, and a 25,830-square-foot fa­cil­i­ty for clin­i­cal man­u­fac­tur­ing, ac­cord­ing to Catal­ent’s web­site.

Cy­to­Dyn's for­mer CEO Nad­er Pourhas­san was sen­tenced Fri­day to 30 months in prison for mis­lead­ing in­vestors about the prospects of a po­ten­tial drug and then sell­ing his per­son­al stock in the com­pa­ny at ar­ti­fi­cial­ly in­flat­ed prices.

Pri­or to Pourhas­san's fir­ing in 2022, Cy­to­Dyn was known for its ag­gres­sive pro­mo­tion­al cam­paigns to tout the un­sub­stan­ti­at­ed po­ten­tial of its drug leron­limab for Covid-19, the De­part­ment of Jus­tice said. Pourhas­san ap­peared on we­b­casts and record­ed videos to push the drug, even af­ter the FDA re­ject­ed it as a treat­ment for HIV, its orig­i­nal in­di­ca­tion, and the drug failed a pair of Covid-19 stud­ies.

The DOJ said Mon­day that be­tween 2018 and 2021, Pourhas­san in­ten­tion­al­ly mis­led in­vestors about leron­limab's prospects for ap­proval. Pourhas­san then sold his 4.8 mil­lion shares of Cy­to­Dyn stock and pock­et­ed $4.4 mil­lion, the de­part­ment said.

The UK’s Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) seized al­most 20 mil­lion dos­es of il­le­gal­ly trad­ed med­i­cines with an es­ti­mat­ed val­ue of near­ly £45 mil­lion (about $61.5 mil­lion) in 2025.

This is an in­crease from 2024, when the MHRA said it ob­tained 17 mil­lion dos­es of il­le­gal­ly trad­ed med­i­cines, with an es­ti­mat­ed val­ue of £40 mil­lion. That was al­so up from the 15.5 mil­lion dos­es seized in 2023, val­ued at £30 mil­lion.

Out of the il­le­gal med­i­cines ob­tained last year, the drugs in­clud­ed al­most 10 mil­lion dos­es of seda­tives, four mil­lion dos­es of painkillers, and 427,300 dos­es of ner­vous sys­tem agents, the agency said on Mon­day morn­ing.

Fur­ther, over 5,600 GLP-1 in­jec­tions mar­ket­ed as weight loss med­i­cines were seized by the MHRA.

The agency’s Crim­i­nal En­force­ment Unit (CEU) al­so shut down an il­le­gal man­u­fac­tur­ing site in Northamp­ton, UK, in Oc­to­ber that was mak­ing un­li­censed weight loss drugs.

Gen­mab has stopped en­rolling pa­tients for an ear­ly-stage tri­al of a can­cer can­di­date it ob­tained in its $1.8 bil­lion ac­qui­si­tion of US-Chi­na biotech Pro­found­Bio.

The Phase 1/2 study of GEN1286 was meant to en­roll 260 pa­tients with ad­vanced sol­id tu­mors, but it has stopped at just 23, ac­cord­ing to an up­date on Clin­i­cal­Tri­als.gov this month. The up­date al­so notes that the tri­al is “ac­tive, not re­cruit­ing.” Gen­mab con­firmed to End­points News that the in­for­ma­tion is ac­cu­rate, but de­clined to pro­vide fur­ther com­ment.

GEN1286 is a bis­pe­cif­ic ADC that tar­gets EGFR and c-Met. Gen­mab ob­tained a dif­fer­ent drug with the same ap­proach in its $8 bil­lion ac­qui­si­tion of Merus, an­nounced in Sep­tem­ber. That can­di­date, dubbed MCLA-129, is al­so in Phase 1/2 for ad­vanced sol­id tu­mors.

Sarep­ta said the ef­fects of its Duchenne mus­cu­lar dy­s­tro­phy gene ther­a­py were durable three years af­ter treat­ment, based on longer-term find­ings from pa­tients in its key clin­i­cal tri­al.

The da­ta come af­ter a tu­mul­tuous year for Sarep­ta and its gene ther­a&