→ Mayo Clin­ic is open­ing up its sprawl­ing clin­i­cal data­base to nfer­ence, the Cam­bridge, MA-based AI start­up it’s long part­nered with and re­cent­ly backed in a $60 mil­lion round. The project aims to dig­i­tize 25 mil­lion tis­sue slides with­in the next 2 to 2.5 years, Fierce­Biotech re­port­ed, in ad­di­tion to an­no­tat­ing, link­ing and tag­ging writ­ten physi­cian notes. Af­ter sort­ing through the da­ta, nfer­ence will use the plat­form to iden­ti­fy new tar­gets and bio­mark­ers as well as ap­ply it in clin­i­cal tri­al re­cruit­ment and re­al-world ev­i­dence gen­er­a­tion.

→ Cypri­um Ther­a­peu­tics, one of the star­tups in­cu­bat­ed by Fortress Biotech, has been grant­ed rare pe­di­atric dis­ease des­ig­na­tion by the FDA for cop­per his­tid­i­nate, al­so re­ferred to as CUTX-101, for the treat­ment of Menkes dis­ease. The drug — which is de­signed to boost blood and brain cop­per lev­els — has al­so gained or­phan and fast track sta­tus.

→ In an ex­pan­sion of its glob­al foot­print, WuXi Bi­o­log­ics has ac­quired a drug prod­uct man­u­fac­tur­ing plant from Bay­er. The fa­cil­i­ty, lo­cat­ed in Lev­erkusen, Ger­many, will al­so serve as a back-up pro­duc­tion site for Bay­er’s Ko­val­try, a he­mo­phil­ia A treat­ment, once WuXi takes over.

→ South Ko­rea’s Cell­tri­on has plans to build a new plant in Chi­na to man­u­fac­ture its biosim­i­lars as it ad­vances a Rem­i­cade copy­cat in the coun­try. Chair­man Jung-jin Seo said at the JP Mor­gan con­fer­ence that the fa­cil­i­ty will have a pro­duc­tion ca­pac­i­ty of 120,000 liters, ac­cord­ing to Yon­hap News Agency.

→ No­var­tis, J&J, Eli Lil­ly, Pfiz­er and GSK are join­ing the Gates Foun­da­tion on a phil­an­thropic com­mu­ni­ty-based pri­ma­ry health­care ini­tia­tive in six African coun­tries led by two char­i­ties. The drug­mak­ers will “con­tribute dis­ease-spe­cif­ic ex­per­tise and ex­pe­ri­ence in the dis­cov­ery and de­vel­op­ment of new tools, which will sup­ple­ment the com­mu­ni­ty health work­er mod­els.” They would al­so each con­tribute $1.5 mil­lion to the project.

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Eisai will eliminate 91 after it out-licensed a seizure drug.

An Eisai spokesperson told Endpoints News that the change-up is tied to Fycompa, a seizure treatment that Florida rare disease biotech Catalyst Pharmaceuticals agreed to pay $160 million to Eisai in exchange for commercial rights back in December. The job cuts were originally flagged in a New Jersey state WARN notice.

The spokesperson said that Catalyst indicated interest in retaining up to 40 employees who work on Fycompa. Those who qualify will have an opportunity to interview with Catalyst.

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.