Mayo Clin­ic launch­es clin­i­cal an­a­lyt­ics plat­form with nfer­ence; WuXi buys Ger­man plant from Bay­er

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.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

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.

Trodelvy notch­es a win in most com­mon form of breast can­cer

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 cut­ting 91 jobs af­ter out-li­cense deal; Mer­ck touts first-line Keytru­da re­sults in en­dome­tri­al can­cer

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.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

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.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

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.