A fed­er­al judge said the gov­ern­ment did not run afoul of the law when it re­quired John­son & John­son to seek ap­proval be­fore im­ple­ment­ing its pro­posed 340B re­bate mod­el.

The Fri­day de­ci­sion marks an­oth­er court win for HHS and its sub­agency the Health Re­sources and Ser­vices Ad­min­is­tra­tion, which has ar­gued that the lit­i­ga­tion could have a “wide-rang­ing im­pact” on the fed­er­al drug dis­count pro­gram known as 340B.

J&J has ar­gued that the 340B pro­gram is “reg­u­lar­ly abused” and in­tro­duced a plan last year that would re­quire hos­pi­tals to pur­chase 340B-el­i­gi­ble drugs at mar­ket price and re­coup the dis­counts via re­bates, as op­posed to up­front. The com­pa­ny al­leged in a law­suit that HRSA was wrong to block J&J’s re­bate mod­el be­cause the com­pa­ny did not re­ceive pri­or agency ap­proval.

The FDA is elim­i­nat­ing a safe­ty mon­i­tor­ing pro­gram for all CAR-T ther­a­pies, say­ing the cell ther­a­pies can be used safe­ly and ef­fec­tive­ly with­out it.

The agency said Thurs­day it de­ter­mined the pro­gram known as Risk Eval­u­a­tion and Mit­i­ga­tion Strate­gies, or REMS, "is no longer nec­es­sary” to en­sure the ben­e­fits of CAR-T ther­a­pies out­weigh the safe­ty risks, not­ing that the de­ci­sion would re­duce the bur­den on the health­care sys­tem.

The FDA al­so out­lined sev­er­al la­bel changes for the CAR-T ther­a­pies that will sub­stan­tial­ly re­duce the mon­i­tor­ing re­quire­ments. The re­stric­tions on pa­tients dri­ving were re­duced to two weeks from eight weeks, as were re­quire­ments for pa­tients to stay close to treat­ment cen­ters. They now on­ly need to do so for two weeks in­stead of four weeks.

Up­com­ing Eu­ro­pean leg­isla­tive changes should in­clude new in­cen­tives to boost ear­ly cap­i­tal for de­vel­op­ing cell and gene ther­a­pies, more than 30 biotech CEOs urged this week to EU law­mak­ers.

Sev­er­al CEOs trav­eled to Brus­sels on Mon­day to meet with pol­i­cy­mak­ers on how the EU can re­gain its com­pet­i­tive­ness in ad­vanced ther­a­pies and to ex­press "a sense of ur­gency with some quick wins and so­lu­tions that could help the field," Fredrik Wess­berg, CEO of CCRM Nordic, a non­prof­it fo­cused on ad­vanced ther­a­py med­i­c­i­nal prod­ucts, told End­points News.

The ex­ec­u­tives are ral­ly­ing be­hind a pol­i­cy brief that calls to not on­ly in­crease ear­ly-stage cap­i­tal but re­duce du­plica­tive reg­u­la­to­ry sub­mis­sions and adopt new pi­lot pro­grams on bet­ter EU-lev­el co­or­di­na­tion for com­mer­cial­iz­ing cell and gene ther­a­pies, es­pe­cial­ly for ul­tra-rare con­di­tions.

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.

In­novent said on Fri­day that its obe­si­ty med­i­cine maz­du­tide has been ap­proved in Chi­na, be­com­ing the first dual GLP-1/glucagon ag­o­nist to be green­lit for the dis­ease any­where in the world.

The drug will be­come the third of the new gen­er­a­tion of in­cretin-based drugs to reach the mar­ket in Chi­na, af­ter No­vo Nordisk’s We­govy and Eli Lil­ly’s Zep­bound.

The ap­proval was part­ly based on da­ta from the Chi­na-based GLO­RY-1 tri­al. In that Phase 3 study, 3 mg and 6 mg dos­es of maz­du­tide caused an av­er­age weight loss of 12% and 14.8% af­ter rough­ly 11 months of treat­ment. The weight loss with place­bo was 0.5%.

Around half the par­tic­i­pants treat­ed with the high­er dose lost at least 15% of their weight.