Re­search­ing, cloning and breed­ing gene-edit­ed pigs are core to eGe­n­e­sis’ au­da­cious mis­sion to grow or­gans that can be xeno­trans­plant­ed in­to hu­mans. But per­haps un­sur­pris­ing­ly, lit­tle of that ac­tu­al­ly hap­pens at its Cam­bridge, MA labs.

Rather, the biotech works with ex­ter­nal par­ties for that part of the R&D and man­u­fac­tur­ing work. As eGe­n­e­sis ap­proach­es a fi­nal ver­sion of the gene-edit­ed or­gans that it will test in an­i­mals, it’s ac­quir­ing one of those part­ners and in­te­grat­ing it as a sub­sidiary.

ICBiotec’s 15-per­son team will stay in the Mid­west. In ad­di­tion to the ex­ist­ing fa­cil­i­ties and equip­ment, eGe­n­e­sis al­so gains ac­cess to un­de­vel­oped land they can build on.

The way they work to­geth­er — with eGe­n­e­sis study­ing fi­brob­last cells in dish­es and turn­ing over gene-edit­ing pay­loads they de­vel­op in the lab to ICB for fur­ther test­ing — won’t change, said CEO Paul Sekhri; eGe­n­e­sis is mere­ly tran­si­tion­ing from the largest client of ICB to its own­er.

“They have a few oth­er cus­tomers that we’ll prob­a­bly en­sure that there’s a prop­er tran­si­tion, but to be hon­est with you I think we will need all of their ca­pa­bil­i­ties, which is one of the rea­sons why we did the trans­ac­tion in the first place,” he said.

De­spite pan­dem­ic-re­lat­ed re­stric­tions, eGe­n­e­sis is still on track to fi­nal­ize the recipe for ge­net­i­cal­ly en­gi­neer­ing the pigs from which they will har­vest or­gans to test in an­i­mal mod­els for safe­ty and ef­fi­ca­cy — be­gin­ning with the kid­ney. In the US alone, there are al­most 100,000 peo­ple on the kid­ney wait­ing list but on­ly around 14,000 trans­plants per­formed each year.

“The re­search nev­er stopped, it just was slowed down a bit be­cause you just lit­er­al­ly couldn’t have the same con­cen­tra­tion of peo­ple in the lab as we had in the past,” Sekhri said.

The slog to­ward the clin­ic will in­volve many more reg­u­la­tor hur­dles, some of which would be un­fa­mil­iar even to the FDA as it deals with the eth­i­cal and tech­ni­cal im­pli­ca­tions of this sci-fi wor­thy un­der­tak­ing. The chief re­quire­ment for a green light to the clin­ic, Sekhri has pre­vi­ous­ly not­ed, is con­sis­tent pre­clin­i­cal re­sults among non-hu­man pri­mates.

Mov­ing ICB ca­pa­bil­i­ties in-house adds band­width for this cru­cial ex­er­cise, he added. Hav­ing bagged $100 mil­lion last No­vem­ber, the deal “doesn’t sig­nif­i­cant­ly im­pact our cash run­way.”

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.”