A Maine fed­er­al judge has blocked the gov­ern­ment from im­ple­ment­ing "this it­er­a­tion" of its 340B re­bate pi­lot pro­gram "pend­ing fur­ther or­der."

The Mon­day rul­ing is a loss for drug­mak­ers that have ar­gued in court that, to­geth­er, they could be on the hook for bil­lions of dol­lars in du­pli­cate dis­counts for drugs ne­go­ti­at­ed by Medicare if the pi­lot didn’t take ef­fect. A lead­ing hos­pi­tal group brought the chal­lenge.

"The Agency’s roll out has in­volved a rather thread­bare ad­min­is­tra­tive record that like­ly fails to con­sid­er and rea­son­ably ex­plain the im­pact of a re­bate mod­el on 340B hos­pi­tals," Judge Lance Walk­er said in a pre­lim­i­nary in­junc­tion rul­ing. The pro­gram was set to take ef­fect on Jan. 1.

HHS did­n't im­me­di­ate­ly re­spond to a re­quest for com­ment.

CMS launched a vol­un­tary pay­ment mod­el de­signed to ex­pand Medicare cov­er­age of GLP-1s, an an­tic­i­pat­ed step from the Trump ad­min­is­tra­tion that builds on its goal to low­er the cost of the pop­u­lar weight loss drugs.

Un­der the mod­el, CMS will di­rect­ly ne­go­ti­ate prices and cov­er­age terms with par­tic­i­pat­ing GLP-1 mak­ers on be­half of Medicare Part D plans and state Med­ic­aid agen­cies. The mod­el, an­nounced this week and dubbed BAL­ANCE, is at least the fourth pay­ment de­mo cre­at­ed as part of Pres­i­dent Don­ald Trump’s “most fa­vored na­tion” drug pric­ing push.

The BAL­ANCE mod­el "builds up­on our his­toric Most Fa­vored Na­tions drug pric­ing deals’ goal of de­moc­ra­tiz­ing ac­cess to weight-loss med­ica­tion, which has been out of reach for so many in need,” CMS Ad­min­is­tra­tor Mehmet Oz said in a state­ment on Tues­day.

Cor­cept Ther­a­peu­tics failed to se­cure US ap­proval for its drug can­di­date as a hor­mon­al dis­or­der treat­ment.

The FDA re­ject­ed Cor­cept’s se­lec­tive cor­ti­sol mod­u­la­tor rela­co­ri­lant for Cush­ing’s syn­drome, ac­cord­ing to a com­pa­ny re­lease shared Wednes­day, a day af­ter the orig­i­nal PDU­FA date. Cush­ing's syn­drome is dri­ven by ex­cess lev­els of the hor­mone cor­ti­sol, lead­ing to high blood pres­sure, high blood sug­ar and obe­si­ty.

The FDA said in its com­plete re­sponse let­ter it could not reach a pos­i­tive opin­ion on rela­co­ri­lan­t's ben­e­fit-risk pro­file with­out "ad­di­tion­al ev­i­dence of ef­fec­tive­ness." Cor­cept plans to meet with the agency to dis­cuss next steps.

Van­da Phar­ma­ceu­ti­cals won FDA ap­proval for what it says is the first new med­i­cine for mo­tion sick­ness in more than four decades.

The oral drug, called Nereus, will be launched in the com­ing months, Van­da said in a Tues­day press re­lease.

The com­pa­ny said Nereus, al­so known as tradip­i­tant, "con­sis­tent­ly demon­strat­ed sig­nif­i­cant re­duc­tions in vom­it­ing" in piv­otal tri­als. In a Phase 3 study con­duct­ed on boats called Mo­tion Sy­ros, vom­it­ing in­ci­dence was 18.3% to 19.5% with Nereus com­pared to 44.3% with place­bo. In an­oth­er Phase 3 called Mo­tion Ser­i­fos, vom­it­ing rates were 10.4% to 18.3% with Nereus ver­sus 37.7% with place­bo. Par­tic­i­pants in the tri­als had his­to­ries of mo­tion sick­ness.

The rare bone dis­ease drug be­ing de­vel­oped by Ul­tragenyx and Mereo Bio­Phar­ma has cat­e­gor­i­cal­ly failed in its late-stage pro­gram, the part­ners re­vealed Mon­day.

Mereo’s stock MREO fell 90% when the Nas­daq opened on Mon­day morn­ing. Ul­tragenyx’s shares RARE slid 40% in ear­ly trade, wip­ing more than $1 bil­lion off its mar­ket cap.

The Phase 2/3 Or­bit and Phase 3 Cos­mic stud­ies were test­ing setrusum­ab in a con­di­tion called os­teo­ge­n­e­sis im­per­fec­ta, in which pa­tients’ bones are weak and can break eas­i­ly. Setrusum­ab in­hibits a pro­tein called scle­rostin, which af­fects bone for­ma­tion. Block­ing scle­rostin should the­o­ret­i­cal­ly boost bone for­ma­tion, den­si­ty and strength.

But nei­ther tri­al was able to show a ben­e­fit for the an­ti­body on the an­nu­al­ized rate of frac­tures, their pri­ma­ry end­points. Or­bit used place­bo as con­trol, and Cos­mic, a pe­di­atric tri­al, com­pared setrusum­ab with bis­pho­s­pho­nates — drugs used to strength­en bones, for in­stance in pa­tients with os­teo­poro­sis.