Arv­inas CEO John Hous­ton is plan­ning to re­tire af­ter more than eight years at the helm, the com­pa­ny an­nounced Wednes­day, as its lead pro­tein de­grad­er pro­gram ap­proach­es an in­flec­tion point.

Arv­inas has been on a roller coast­er dur­ing that time. Hous­ton took the biotech and its tar­get­ed pro­tein de­graders pub­lic, with the promise that the plat­form — col­lo­qui­al­ly short­ened to PRO­TACs — could help ush­er in a wave of new drugs in im­muno-on­col­o­gy and neu­ro­science. Hous­ton en­gi­neered a part­ner­ship with Pfiz­er in 2021, get­ting $1 bil­lion up­front in cash and eq­ui­ty for Arv­inas, and a small­er deal with No­var­tis last year.

More re­cent­ly, Arv­inas has run in­to some head­winds. The com­pa­ny’s lead PRO­TAC pro­gram, vepdeges­trant, dis­ap­point­ed Wall Street in March af­ter a Phase 3 read­out, send­ing its stock price ARVN down about 50% at the time (Arv­inas shares are down 71% in the last 12 months).

The FDA act­ed with­in its purview when it main­tained some safe­ty re­quire­ments for the abor­tion pill mifepri­s­tone fol­low­ing an agency re­view, a fed­er­al court in Wash­ing­ton ruled.

“The Court can­not find, based on the full record be­fore it, that the FDA was ar­bi­trary and capri­cious in its de­ci­sion,” Judge Thomas Rice of the East­ern Dis­trict of Wash­ing­ton said in a cross-sum­ma­ry judge­ment is­sued Tues­day. The rul­ing lift­ed a pre­lim­i­nary in­junc­tion is­sued in 2023 that barred the FDA from al­ter­ing the sta­tus quo or avail­abil­i­ty of mifepri­s­tone un­der the drug's Risk Eval­u­a­tion and Mit­i­ga­tion Strat­e­gy (REMS) pro­gram.

The FDA’s pe­di­atric ad­vi­so­ry com­mit­tee vot­ed al­most unan­i­mous­ly to con­tin­ue mon­i­tor­ing 21 drugs and three vac­cines for side ef­fects, in­clud­ing block­busters such as No­var­tis’ heart drug En­tresto and Mer­ck’s HPV vac­cine Gar­dasil 9.

At the meet­ing Wednes­day, few of the pan­elists ques­tioned the on­go­ing re­views and the FDA said in brief­ing doc­u­ments that it had not iden­ti­fied any new pe­di­atric safe­ty con­cerns in pas­sive sur­veil­lance of ad­verse event re­ports sub­mit­ted to the FDA Ad­verse Event Re­port­ing Sys­tem (FAERS) for the prod­ucts. The FAERS sys­tem is made up of re­ports that are about half con­sumer-sub­mit­ted and half physi­cian-sub­mit­ted, ac­cord­ing to the FDA.

The FDA had been in­ves­ti­gat­ing the safe­ty of 21 drugs and three vac­cines un­der the Pe­di­atric Re­search Eq­ui­ty Act, which pro­vid­ed the agency with the au­thor­i­ty to re­quire cer­tain pe­di­atric stud­ies. The FDA said it was look­ing for "se­ri­ous un­la­beled ad­verse events" in pe­di­atric pa­tients.

John­son & John­son beat back Teva's patent chal­lenge in a fed­er­al ap­peals court rul­ing that clos­es out a years­long fight over J&J’s an­tipsy­chot­ic med­ica­tion In­ve­ga Susten­na.

The US Court of Ap­peals for the Fed­er­al Cir­cuit on Tues­day af­firmed a low­er court de­ci­sion that held Te­va failed to show J&J's as­sert­ed patent claims were in­valid for ob­vi­ous­ness. The rul­ing marks a win for J&J as it looks to block gener­ic com­pe­ti­tion for its long-act­ing schiz­o­phre­nia drug.

J&J’s Janssen sued Te­va in 2018 af­ter the gener­ics mak­er sought FDA ap­proval for its own ver­sion of In­ve­ga Susten­na, a month­ly in­jectable form of a drug called paliperi­done used to treat schiz­o­phre­nia and schizoaf­fec­tive dis­or­der. Te­va chal­lenged the va­lid­i­ty of J&J’s patent, which claims dos­ing reg­i­mens for long-act­ing in­jectable an­tipsy­chot­ic med­i­cines.