Fresh off a re­or­ga­ni­za­tion, Bio­gen’s re­search leader Jane Gro­gan says the biotech has to “look out­side the walls of the com­pa­ny” to avoid be­ing left be­hind.

In her first in­ter­view since then, she told End­points News what ex­act­ly the com­pa­ny is look­ing for. That in­cludes pri­or­i­tiz­ing “ex­ter­nal op­por­tu­ni­ties,” ac­cord­ing to a let­ter to em­ploy­ees last month, in which the com­pa­ny al­so an­nounced job cuts.

Gro­gan said Bio­gen was “re­al­ly ac­tive” at the JP Mor­gan Health­care Con­fer­ence last month and is ex­cit­ed by what has come out of the con­ver­sa­tions. It re­mains in­ter­est­ed in Alzheimer's and neu­ro­log­i­cal dis­eases like ALS, and she em­pha­sized the com­pa­ny's in­ter­est in im­munol­o­gy.

De­moc­rats in the Sen­ate Fi­nance Com­mit­tee are call­ing Robert F. Kennedy Jr.'s new di­vest­ment plans to his son "plain­ly in­ad­e­quate" ahead of a Tues­day vote on whether to ad­vance his nom­i­na­tion to lead HHS.

The vote will be a cru­cial mo­ment for a nom­i­nee who has strug­gled to clar­i­fy his views on vac­cines, and even em­braced the thor­ough­ly de­bunked myth that vac­cines cause autism, as his dis­clo­sures show that he would ben­e­fit fi­nan­cial­ly from vac­cine lit­i­ga­tion.

The vote will come down to Sen. Bill Cas­sidy (R-LA), the chair­man of the Sen­ate Com­mit­tee on Health, Ed­u­ca­tion, La­bor and Pen­sions who grilled Kennedy last week in both the Health and Fi­nance com­mit­tee hear­ings. Re­pub­li­cans con­trol the com­mit­tee's vote mar­gin by one vote. If Cas­sidy votes against Kennedy, and all De­moc­rats vote against him too, the odds of a floor vote and con­fir­ma­tion for Kennedy would be all but ze­ro.

The FDA has cleared two new re­quests to test gene-edit­ed pig kid­ney trans­plan­ta­tion, in­clud­ing a first clin­i­cal tri­al of the tech­nol­o­gy.

Unit­ed Ther­a­peu­tics an­nounced Mon­day that it re­ceived the go-ahead from the FDA to start a clin­i­cal tri­al, and the first trans­plant in the study is ex­pect­ed to take place around mid-year. It's a key mile­stone for xeno­trans­plan­ta­tion, and it lays out for the first time a path for how the tech­nol­o­gy might reach com­mer­cial ap­proval.

In De­cem­ber, com­peti­tor eGe­n­e­sis re­ceived ap­proval for a three-pa­tient kid­ney trans­plant study un­der com­pas­sion­ate use. "The study will eval­u­ate pa­tients with kid­ney fail­ure who are list­ed for a trans­plant but who face a low prob­a­bil­i­ty of re­ceiv­ing a de­ceased donor of­fer with­in a five-year time­frame," the com­pa­ny told End­points News in an emailed state­ment.

While 118 bi­o­log­ics are ex­pect­ed to lose patent pro­tec­tion in the US over the next decade, that $234 bil­lion op­por­tu­ni­ty for biosim­i­lar de­vel­op­ers may not ma­te­ri­al­ize be­cause of sev­er­al chal­lenges, ac­cord­ing to a new re­port from re­search com­pa­ny IQVIA.

On­ly 10% of those 118 bi­o­log­ics have a biosim­i­lar in the pipeline and cur­rent­ly, on­ly 14 out of 62 bi­o­log­ics that will lose patent pro­tec­tion at the end of 2024 have biosim­i­lars, the re­port says. An ad­di­tion­al 19 bi­o­log­ics have biosim­i­lars in clin­i­cal de­vel­op­ment, with five biosim­i­lars al­ready win­ning FDA ap­proval and ex­pect­ing to launch this year, in­clud­ing biosim­i­lars for As­traZeneca's Soliris, Bio­gen's Tysabri, Am­gen's Pro­lia/Xge­va, and J&J's Ste­lara.

So why such a gap in biosim­i­lar de­vel­op­ment con­sid­er­ing how many bi­o­log­ics are com­ing off-patent? The IQVIA re­port, en­ti­tled "As­sess­ing the Biosim­i­lar Void in the U.S.," points to chal­lenges in "reg­u­la­to­ry re­quire­ments, mar­ket ac­cep­tance, high in­vest­ment costs, ob­scu­ri­ty around in­ter­change­abil­i­ty, and re­im­burse­ment."