In­tel­lia has some big plans for the next two years, in­clud­ing piv­otal tri­als for its first two in vi­vo CRISPR ther­a­pies.

The Cam­bridge, MA-based genome edit­ing com­pa­ny on Thurs­day dis­closed its game plan for 2023 and 2024, start­ing with INDs for the in­clu­sion of US sites in stud­ies for NT­LA-2001 and NT­LA-2002 in transthyretin (AT­TR) amy­loi­do­sis with car­diomy­opa­thy and hered­i­tary an­gioede­ma (HAE), re­spec­tive­ly.

AT­TR amy­loi­do­sis with car­diomy­opa­thy is a dis­ease that af­fects the heart and ten­dons and is caused by the ac­cu­mu­la­tion of a wild-type pro­tein called transthyretin. In­tel­lia added that the goal is to kick off the piv­otal study by the end of this year, though those plans are still sub­ject to reg­u­la­to­ry feed­back.

An­oth­er goal is to gear up for a Phase III study in AT­TR amy­loi­do­sis with polyneu­ropa­thy, or AT­TRv-PN.

If things go ac­cord­ing to plan, a Phase II tri­al will start in the first half of this year for NT­LA-2002 in HAE. An on­go­ing tri­al is be­ing run in New Zealand, the Nether­lands, and the UK.

In­tel­lia of­fered a first look at its HAE treat­ment back in Sep­tem­ber, which di­rect­ly ed­its the gene un­der­ly­ing the pro­tein re­spon­si­ble for the swelling at­tacks in pa­tients. At the time, the com­pa­ny re­port­ed that two out of three pa­tients were at­tack-free, and a third was at­tack-free af­ter 10 weeks. A few months lat­er, CEO John Leonard claimed to End­points News that the treat­ment “may be a func­tion­al cure.”

And while it costs to run piv­otal tri­als, In­tel­lia has a sub­stan­tial amount of cash on hand, end­ing 2022 with al­most $1.3 bil­lion in cash and mar­ketable se­cu­ri­ties.

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.

We now know where Roche’s ex-pharma chief Bill Anderson is going.

German pharma giant Bayer announced Wednesday that Anderson will be taking on the role as CEO, less than six weeks after Anderson stepped down from his perch at Roche as head of the group’s pharmaceutical division.

Roche announced back in December that Anderson would depart on Dec. 31 to “pursue opportunities outside of Roche.” His replacement, Genentech vet and Roche’s current head of global product strategy, Teresa Graham, will start her role in March.

As talk of AI this-and-that gobbles up headline after headline, one Big Pharma is losing its AI leader as she transitions to another drug giant: Iya Khalil will trade in her hat as Novartis’ go-to expert and leader in the space for Merck as VP and head of data, AI and genome sciences next week.

After nearly three years leading the artificial intelligence team at Novartis — as Big Pharma and biotechs alike latch onto the ripening AI-for-drug-discovery mode of operation — Khalil will switch employers to head up a similar post at Merck, where she’ll work out of Cambridge, MA beginning Feb. 13, the company tells Endpoints News.