John Crow­ley, CEO of the trade group BIO, says he still sup­ports FDA Com­mis­sion­er Mar­ty Makary even af­ter a se­ries of reg­u­la­to­ry de­ci­sions on his watch have caused frus­tra­tion and con­ster­na­tion among the biotech in­dus­try.

In an in­ter­view with End­points News on Tues­day, Crow­ley said the FDA “needs to con­tin­ue to suc­ceed” and that re­spon­si­ble reg­u­la­to­ry risk is crit­i­cal to fos­ter­ing a healthy ecosys­tem for drug de­vel­op­ers, par­tic­u­lar­ly for rare dis­ease treat­ments. He hasn’t seen as much of that.

“Some of the de­ci­sions have been head-scratch­ers.” Crow­ley said. “We need some sharp re­view and fo­cus, but the pat­tern here has been trou­ble in the rare dis­eases, par­tic­u­lar­ly in cell and gene ther­a­py.”

📉 Bay­er work­force cuts con­tin­ue: The Ger­man con­glom­er­ate re­port­ed 88,078 em­ploy­ees at the end of De­cem­ber, down from 88,500 as the third quar­ter con­clud­ed. When CEO Bill An­der­son came aboard in 2023 and kick­start­ed a mul­ti­year re­struc­tur­ing, the com­pa­ny had more than 100,000 staffers across its three di­vi­sions. Mean­while, Bay­er said it was dis­con­tin­u­ing a Phase 1 Pompe dis­ease AAV gene ther­a­py, co­de­named AC­TUS-101, which was ob­tained from its 2020 AskBio buy. — Rey­nald Cas­tane­da

🗞️ Anap­tys­Bio's spin­off up­date: The biotech named its spin­off com­pa­ny First Tracks Bio­ther­a­peu­tics and will launch it in the sec­ond quar­ter. First Tracks will run Anap­tys­Bio’s im­munol­o­gy port­fo­lio, in­clud­ing its Phase 2 an­ti­body ros­nil­imab for rheuma­toid arthri­tis, as well as pre­clin­i­cal an­ti­bod­ies ANB033 and ANB101. Anap­tys­Bio an­nounced its spin­off plans in Sep­tem­ber. — An­na Brown

Sanofi has paid $135 mil­lion up­front to li­cense a po­ten­tial ther­a­py to tamp down trans­plant re­jec­tion from the Hong Kong-based com­pa­ny Sino Bio­phar­ma­ceu­ti­cal.

The French phar­ma will get ex­clu­sive world­wide rights to de­vel­op, make and sell rovadic­i­tinib, in a deal made via Sino’s sub­sidiary Chia Tai Tian­qing Phar­ma­ceu­ti­cal. Sanofi is on the hook for up to $1.4 bil­lion in mile­stone pay­ments, plus pos­si­ble dou­ble-dig­it tiered roy­al­ties, ac­cord­ing to a Wednes­day se­cu­ri­ties fil­ing.

Sino de­scribed rovadic­i­tinib as its “break­out star” in the field of rare dis­eases. It is a first-in-class in­hibitor of both JAK, through which it ex­erts an­ti-in­flam­ma­to­ry ef­fects, and an­oth­er en­zyme called ROCK. ROCK block­ade sup­press­es over­ac­ti­vat­ed T helper cells and boosts reg­u­la­to­ry T cells, help­ing the pa­tient achieve im­mune home­osta­sis.

UCB is team­ing up with Chi­nese biotech An­ten­gene to de­vel­op a T cell en­gager in Am­gen's are­na, along­side bub­bling com­pe­ti­tion from As­traZeneca, Mer­ck and oth­ers.

The Bel­gian phar­ma is step­ping in­to the CD19xCD3 space in a pact with An­ten­gene that fea­tures $60 mil­lion up­front and $20 mil­lion in near-term mile­stones. The biotech could col­lect an­oth­er $1.1 bil­lion across de­vel­op­ment, reg­u­la­to­ry and sales mile­stones un­der the deal an­nounced Tues­day evening.

At the heart of the deal is ATG-201, which is part of An­ten­gene's sprawl­ing pipeline of T cell en­gagers.

An­ten­gene will run Phase 1 tri­als of ATG‑201 and then hand over the de­vel­op­ment du­ties to UCB. The biotech said it will ask Chi­nese and Aus­tralian health reg­u­la­tors to ap­prove the stud­ies in the sec­ond quar­ter of this year.