So­sei Hep­tares is team­ing up with a big-name part­ner: Al­pha­bet’s Ver­i­ly.

No fi­nan­cials were dis­closed, but the pair will aim to use Ver­i­ly’s im­mune pro­fil­ing and So­sei Hep­tares’ GPCR drug de­sign ca­pa­bil­i­ties to de­vel­op a va­ri­ety of new ther­a­peu­tics. The col­lab­o­ra­tion will fo­cus on GPCR drugs in the im­munol­o­gy, gas­troen­terol­o­gy and im­muno-on­col­o­gy spaces, as well as oth­er dis­or­ders with im­muno­pro­tec­tive or im­munopath­o­gen­ic mech­a­nisms, the com­pa­nies said.

“Im­munol­o­gy is a key area of fo­cus for So­sei Hep­tares and this new col­lab­o­ra­tion brings to­geth­er two world-class tech­nolo­gies and teams with the skills and ex­per­tise to de­fine key GPCRs as tar­gets for the dis­cov­ery of new med­i­cines that could have sig­nif­i­cant im­pact on pa­tients with im­mune-based dis­eases world­wide,” So­sei VP for drug dis­cov­ery Matt Barnes said in a state­ment. — Max Gel­man

Ob­sE­va un­veils new PhI­II da­ta for en­dometrio­sis pain 

Just a month af­ter women’s health biotech Ob­sE­va brought on a new CFO, the com­pa­ny has some Phase III tri­al da­ta for pain as­so­ci­at­ed with en­dometrio­sis.

The tri­al was for lin­zagolix, an oral GnRH an­tag­o­nist can­di­date for women with mod­er­ate-to-se­vere en­dometrio­sis-as­so­ci­at­ed pain, al­so known as EAP. Two dos­es — 200 mg once-dai­ly with add-back ther­a­py (ABT) and 75 mg dai­ly with­out back ther­a­py — were test­ed.

The 200 mg dose, ac­cord­ing to Ob­sE­va, met the study’s co-pri­ma­ry ef­fi­ca­cy ob­jec­tives: re­duc­ing dys­men­or­rhea (DYS) and non-men­stru­al pelvic pain (NMPP) at 3 months. At 6 months of treat­ment at 200 mg, there were list­ed im­prove­ments in five sec­ondary end­points: dys­men­or­rhea, non-men­stru­al pelvic pain, dyschezia, over­all pelvic pain, and abil­i­ty to do dai­ly ac­tiv­i­ties.

The 75 mg dose did show a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion ver­sus place­bo in DYS at 3 months. Al­though it showed im­prove­ment in NMPP at 3 months, it did not reach sta­tis­ti­cal sig­nif­i­cance ver­sus place­bo.

Ob­sE­va CMO Eliz­a­beth Gar­ner praised the re­sults, say­ing in a state­ment that the biotech plans to com­plete its Phase III pro­gram for EAP, and said that it would ex­plore a non-ABT op­tion for that in­di­ca­tion. — Paul Schloess­er

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”