When the Supreme Court hears ar­gu­ments this week over a pre­scrip­tion-strength pill de­rived from fish oil, the en­tire gener­ic drug in­dus­try will be watch­ing.

The case could have broad im­pli­ca­tions on how new gener­ics get sold, and how long brand-name drug man­u­fac­tur­ers can de­fend their mo­nop­o­lies. Hik­ma launched a gener­ic ver­sion of Amarin’s heart drug Vas­cepa in 2020, but on­ly for one in­di­ca­tion: se­vere hy­per­triglyc­eridemia. To avoid in­fring­ing Vas­cepa’s patents, Hik­ma left the drug’s new­er — and big­ger — in­di­ca­tion of re­duc­ing car­dio­vas­cu­lar risk off its la­bel.

It’s a com­mon­ly used prac­tice called “skin­ny la­bel­ing,” which al­lows gener­ic drugs to launch years be­fore they oth­er­wise would by carv­ing out patent­ed in­di­ca­tions from the la­bel. But Amarin has ac­cused Hik­ma of en­cour­ag­ing physi­cians to pre­scribe its gener­ic for heart risk any­way, un­der­min­ing its patent pro­tec­tions.

The FDA is launch­ing a pi­lot pro­gram to col­lect and re­view clin­i­cal tri­al da­ta in re­al time, giv­ing sci­en­tif­ic re­view­ers ac­cess to the da­ta as it flows in, the agency an­nounced Tues­day.

As­traZeneca and Am­gen will be the first com­pa­nies to par­tic­i­pate in the pro­gram. The goal is "to shave off months, if not years," from drug de­vel­op­ment, FDA AI chief Je­re­my Walsh told re­porters ahead of the an­nounce­ment.

The FDA hopes it will mean less pa­per­work, less emp­ty time be­tween drug tri­als and swifter recog­ni­tion of safe­ty sig­nals. Walsh told re­porters that he be­lieves the change could shave as much as 40% “of an over­all clin­i­cal tri­al time.”

“That's the tar­get goal that we're look­ing for,” he said.

Pfiz­er is staving off Vyn­damax com­pe­ti­tion for an­oth­er two years.

The drug, al­so known as tafamidis, is among Pfiz­er’s top three best-sell­ing med­i­cines and vac­cines. Vyn­damax is ap­proved for a heart con­di­tion caused by transthyretin me­di­at­ed amy­loi­do­sis, or AT­TR-CM. The po­ten­tial­ly fa­tal dis­ease is caused by a mis­shapen pro­tein that ac­cu­mu­lates in the heart and caus­es its walls to be­come stiff.

Pfiz­er had been brac­ing for gener­ic com­pe­ti­tion as ear­ly as 2029, and an­tic­i­pat­ed “a sig­nif­i­cant de­cline in US rev­enues” start­ing that year. But on Tues­day, the phar­ma gi­ant said it struck set­tle­ment agree­ments with three gener­ic drug man­u­fac­tur­ers that will ex­tend Vyn­damax’s patent pro­tec­tion to June 2031.

The FDA ac­cused Chemo­Cen­tryx of ma­nip­u­lat­ing the re­sults of a piv­otal clin­i­cal tri­al used to ap­prove the drug Tavneos, es­ca­lat­ing the agen­cy's ef­fort to pull the treat­ment from the mar­ket.

"New in­for­ma­tion shows that the ap­pli­cant’s un­blind­ed study per­son­nel ma­nip­u­lat­ed end­point re­sults for the Phase 3 study," the FDA said in a let­ter out­lin­ing its con­cerns and de­mand­ing that Am­gen re­move the prod­uct. That lan­guage ap­pears to be far more se­vere than what has been pub­lic so far.

"CDER can no longer con­clude that there is, or has ever been, a valid demon­stra­tion of sub­stan­tial ev­i­dence of ef­fec­tive­ness for TAVNEOS," the FDA wrote, adding that the al­leged da­ta changes "ir­rev­o­ca­bly com­pro­mis­es the cred­i­bil­i­ty of the study re­sults.”

The pan-RAS space con­tin­ues to gain mo­men­tum, as Ab­b­Vie signs up for a shot at en­ter­ing a field with the po­ten­tial to dras­ti­cal­ly al­ter the treat­ment of cer­tain can­cers.

The Chica­go-area phar­ma gi­ant has signed an agree­ment that gives it the ex­clu­sive op­tion to ac­quire a lit­tle-known biotech named Kestrel Ther­a­peu­tics for up to $1.45 bil­lion, ac­cord­ing to a Tues­day press re­lease from Kestrel. The drug will have to hit cer­tain undis­closed de­vel­op­ment mile­stones to bring the ac­qui­si­tion to fruition.

The move comes a few months af­ter Ab­b­Vie was re­port­ed­ly near­ing a deal to buy Rev­o­lu­tion Med­i­cines, but Ab­b­Vie lat­er de­nied those ru­mors.

Rev­o­lu­tion Med­i­cines’ stand­out da­ta in pan­cre­at­ic can­cer en­er­gized the pan-RAS land­scape. Then, Eras­ca got in­to the act with da­ta of its own — and an ac­com­pa­ny­ing