The FDA is get­ting clos­er to an­nounc­ing a di­rec­tor of the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, sources told End­points News, fol­low­ing the con­tro­ver­sial tenure of out­go­ing leader Vinay Prasad.

A lead­ing can­di­date for the post is Houman Hem­mati, peo­ple who spoke on con­di­tion of anonymi­ty told End­points. Hem­mati is a long­time biotech ex­ec­u­tive and oph­thal­mol­o­gist who has served in more than a dozen in­dus­try roles, posts heav­i­ly on so­cial me­dia and has raised ques­tions about the Covid-19 vac­cine.

Hem­mati didn’t re­spond to a re­quest for com­ment on Mon­day. An HHS spokesper­son told End­points, "No de­ci­sion has been made on the se­lec­tion of the next CBER di­rec­tor. We con­tin­ue to vet high­ly qual­i­fied can­di­dates."

Biotechs with sin­gle prod­ucts in the mar­ket are like­ly on edge about how Pres­i­dent Don­ald Trump’s phar­ma tar­iffs and “most fa­vored na­tion” pric­ing will play out, Rhythm Phar­ma­ceu­ti­cals CEO David Meek­er told End­points News in an in­ter­view.

The Boston-based rare dis­ease biotech mar­kets Im­civree for weight man­age­ment in pa­tients with cer­tain rare ge­net­ic dis­or­ders. Meek­er said sim­i­lar com­pa­nies with one com­mer­cial prod­uct may al­so have con­cerns that if they launched their drugs over­seas first, that typ­i­cal­ly low­er price would al­so be­come the list price in the US un­der po­ten­tial MFN pric­ing ne­go­ti­a­tions.

Trump an­nounced 100% phar­ma levies this month, but on­ly some phar­ma com­pa­nies are like­ly to shoul­der those tar­iffs in full. MFN pric­ing deals be­tween drug­mak­ers and the White House ex­empt com­pa­nies from phar­ma tar­iffs.

Rev­o­lu­tion Med­i­cines re­port­ed Mon­day that its ex­per­i­men­tal RAS in­hibitor called darax­on­ra­sib suc­ceed­ed in a reg­is­tra­tional tri­al for pan­cre­at­ic can­cer.

And now, the com­pa­ny plans to ask the FDA to ap­prove the ther­a­py un­der the agency’s Com­mis­sion­er’s Na­tion­al Pri­or­i­ty Vouch­er pro­gram that’s meant to speed up re­view times for a small num­ber of se­lect­ed drugs.

In a Phase 3 tri­al, darax­on­ra­sib led pa­tients with metasta­t­ic pan­cre­at­ic duc­tal ade­no­car­ci­no­ma to sur­vive for a me­di­an 13.2 months com­pared to 6.7 months with chemother­a­py, the com­pa­ny said. That means darax­on­ra­sib cut the risk of death by 60% ver­sus chemother­a­py.

“Break­ing the one-year bar­ri­er in pan­cre­at­ic can­cer is an enor­mous achieve­ment,” Rev­o­lu­tion Med­i­cines CEO Mark Gold­smith told End­points News.

Plus, news about Ab­b­Vie, Syn­Ox, Eli Lil­ly's Jaypir­ca, Im­a­geneBio, Nx­era Phar­ma, Neu­ro­crine and No­var­tis:

Neo­morph rais­es $100M more for mol­e­c­u­lar glues: San Diego-based Neo­morph has raised a $100 mil­lion Se­ries B round led by its found­ing in­vestor, Deer­field Man­age­ment. The start­up dosed its first pa­tient in Feb­ru­ary in a tri­al of NEO-811, its lead mol­e­c­u­lar glue de­grad­er that tar­gets a hard-to-drug dri­ver of a type of kid­ney can­cer. Neo­morph has al­so signed re­search deals with Bio­gen, Ab­b­Vie and No­vo Nordisk since emerg­ing from stealth in De­cem­ber 2020 with a $109 mil­lion Se­ries A round. — An­drew Dunn