Pe­ter Marks, the for­mer FDA of­fi­cial, is join­ing Eli Lil­ly as a se­nior vice pres­i­dent for mol­e­cule dis­cov­ery and the head of in­fec­tious dis­eases.

Marks and a spokesper­son for Lil­ly con­firmed his ap­point­ment to End­points News.

"Pe­ter's ex­per­tise strength­ens our abil­i­ties across mul­ti­ple ar­eas, both in our ex­ist­ing port­fo­lio and in our work in emerg­ing ar­eas," a com­pa­ny spokesper­son said in a state­ment to End­points.

Bio­Cen­tu­ry first re­port­ed his ap­point­ment.

Marks, who led the FDA's Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search for near­ly a decade, was one of the reg­u­la­tor's most high-pro­file de­par­tures when he re­signed in March in protest of HHS Sec­re­tary Robert F. Kennedy Jr.’s stance on vac­cine safe­ty. As head of CBER, Marks over­saw the reg­u­la­tion of vac­cines and cell and gene ther­a­pies.

The FDA has cleared Boehringer In­gel­heim’s id­io­path­ic pul­monary fi­bro­sis treat­ment, mark­ing the first new drug ap­proved for the dis­ease in over a decade.

The drug, neran­domi­last, will be mar­ket­ed as Jas­cayd, the FDA said in its an­nounce­ment. A list price was­n't im­me­di­ate­ly avail­able.

Id­io­path­ic pul­monary fi­bro­sis, or IPF, is a chron­ic and pro­gres­sive dis­ease that leads to lung tis­sue scar­ring, which can cause trou­ble breath­ing, chest pain and cough. Jas­cayd is a PDE4 in­hibitor, and is meant to curb both in­flam­ma­tion and scar­ring as­so­ci­at­ed with the dis­ease.

In two clin­i­cal tri­als, pa­tients on Jas­cayd had less of a de­cline of a mea­sure of lung func­tion called forced vi­tal ca­pac­i­ty than pa­tients who got a place­bo.

A fed­er­al ap­peals court re­ject­ed No­vo Nordisk’s chal­lenge against Medicare drug price ne­go­ti­a­tions on Mon­day, mark­ing an­oth­er loss for the phar­ma in­dus­try in a long-run­ning le­gal bat­tle that could be head­ed for the Supreme Court.

The US Court of Ap­peals for the Third Cir­cuit wrote in an opin­ion that par­tic­i­pa­tion in drug price ne­go­ti­a­tions is vol­un­tary, and doesn’t vi­o­late No­vo Nordisk’s free speech or due process rights. No­vo al­so ar­gued that CMS erred in group­ing its No­volog and Fi­asp in­sulin prod­ucts to­geth­er as one ne­go­ti­a­tion-el­i­gi­ble drug, but the court de­ter­mined that it lacks ju­ris­dic­tion to ad­dress the mer­its of that is­sue.

“We can­not re­view CMS’s de­ter­mi­na­tions or the in­ter­nal process­es CMS used to make them,” the opin­ion states.