The Eu­ro­pean Med­i­cines Agency is work­ing on new ad­vice for health­care providers treat­ing pa­tients with Zol­gens­ma, five months af­ter two child pa­tient deaths in Rus­sia and Kaza­khstan.

That in­cludes mon­i­tor­ing the liv­er func­tion of pa­tients treat­ed with the gene ther­a­py and quick­ly as­sess­ing cas­es of sus­pect­ed liv­er dam­age, Reuters first re­port­ed.

The EMA re­leased its own state­ment af­ter the Phar­ma­covig­i­lance Risk As­sess­ment Com­mit­tee meet­ing on Jan. 12:

Health­care pro­fes­sion­als should prompt­ly as­sess pa­tients with wors­en­ing liv­er func­tion tests and/or signs or symp­toms of acute liv­er ill­ness. If pa­tients do not re­spond ad­e­quate­ly to treat­ment with cor­ti­cos­teroids, treat­ing physi­cians should con­sult a pae­di­atric gas­troen­terol­o­gist or he­pa­tol­o­gist and con­sid­er ad­just­ment of the cor­ti­cos­teroid reg­i­men.

Back in Au­gust, No­var­tis con­firmed that two pa­tients had died from acute liv­er fail­ure af­ter treat­ment with Zol­gens­ma, No­var­tis’ gene ther­a­py de­signed as a one-time treat­ment for spinal mus­cu­lar at­ro­phy, a rare and fa­tal dis­ease. They died ap­prox­i­mate­ly five to six weeks post-Zol­gens­ma in­fu­sion, and about one to 10 days af­ter doc­tors be­gan to ta­per cor­ti­cos­teroids.

A No­var­tis spokesper­son told End­points News that dis­cus­sions with the EMA have been on­go­ing since No­var­tis first no­ti­fied the agency of these cas­es and that there is no longer an in­ves­ti­ga­tion in­to the two pa­tient deaths.

When asked about the in­ves­ti­ga­tion’s find­ings, the com­pa­ny re­spond­ed, “The two deaths were the re­sult of acute liv­er fail­ure fol­low­ing treat­ment with Zol­gens­ma. Liv­er tox­i­c­i­ty, in­clud­ing acute liv­er fail­ure, is a known risk as­so­ci­at­ed with Zol­gens­ma and the sub­ject of la­bel­ing in­clud­ing our boxed warn­ing in US.”

Fur­ther dis­cus­sion on guid­ance for physi­cians will go to sev­er­al more com­mit­tees with­in the EMA, in­clud­ing the Com­mit­tee for Ad­vanced Ther­a­pies and to the Hu­man Med­i­cines Com­mit­tee.

If the guid­ance is ap­proved, it will be sent to health­care providers by the mar­ket­ing au­tho­riza­tion hold­ers.

“We con­tin­u­al­ly as­sess changes to treat­ment or mon­i­tor­ing rec­om­men­da­tions for Zol­gens­ma. Pend­ing health au­thor­i­ty re­view and ap­proval, the Zol­gens­ma la­bel will be up­dat­ed to in­form pre­scribers that fa­tal acute liv­er fail­ure has been re­port­ed,” a No­var­tis spokesper­son told End­points via email. “Ad­di­tion­al­ly, com­mu­ni­ca­tions dis­trib­uted to pre­scribers stress the im­por­tance of en­hanced mon­i­tor­ing of liv­er func­tion dur­ing cor­ti­cos­teroid ta­per­ing pe­ri­od, and for at least three months af­ter Zol­gens­ma in­fu­sion, and/or at oth­er times as clin­i­cal­ly in­di­cat­ed.”

The drug won con­di­tion­al EU ap­proval in 2020 and is con­sid­ered one of the most ex­pen­sive drugs in the world, with a price tag of $2.1 mil­lion.

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.