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.

Gar­raway is a rel­a­tive­ly new 2019 ad­di­tion to Roche. He was pre­vi­ous­ly named se­nior vice pres­i­dent of glob­al de­vel­op­ment and med­ical af­fairs for Eli Lil­ly’s on­col­o­gy busi­ness in 2017.

Ac­cord­ing to the com­pa­ny’s an­nounce­ment, Gra­ham start­ed out at Genen­tech, a sub­sidiary of Roche, in 2005 in prod­uct man­age­ment and worked her way up through mar­ket­ing, field re­im­burse­ment man­age­ment and man­ag­ing “ma­jor as­pects” of Genen­tech’s port­fo­lio un­til she moved in­to her cur­rent po­si­tion.

She’s tak­ing over for Bill An­der­son, who stepped down at the end of 2022 to “pur­sue op­por­tu­ni­ties out­side of Roche.”

Roche’s newest top lead­ers have a lot on their plate this spring, with the be­gin­ning of a Phase II study for the Hunt­ing­ton’s dis­ease drug tomin­ersen to see whether the drug can slow pro­gres­sion in adults with ear­ly-stage symp­toms.

The Phase II tri­al is com­ing off of the back of a flunked Phase III test of the drug af­ter lat­er-stage pa­tients with the dis­ease seemed to be worse off than those who were on the place­bo. The new tri­al will have low­er dos­es for a short­er pe­ri­od of time.

Gra­ham and Schi­neck­er are al­so tak­ing over a com­pa­ny with a more con­sol­i­dat­ed pipeline: the com­pa­ny dumped its com­bi­na­tion of ipatasert­ib and abi­raterone af­ter fail­ures in tri­als for breast and prostate can­cer, ac­cord­ing to a Q4 up­date.

Oth­er pro­grams are in the bin as well, in­clud­ing sev­er­al com­bi­na­tions of its block­buster can­cer drug Tecen­triq and the Alzheimer’s can­di­date gan­tenerum­ab, which has re­peat­ed­ly failed to hit pri­ma­ry end­points in tri­als.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Mass­a­chu­setts judge dis­miss­es law­suit against Bio­gen over failed launch of Alzheimer's drug Aduhelm

A Massachusetts federal judge on Wednesday dismissed a class action lawsuit filed by investors against Biogen and several of its current and former executives over the company’s failed Alzheimer’s drug, Aduhelm (aducanumab).

The investors argued that Biogen’s contact with the FDA was unlawful and that the company made 25 false and misleading statements, including statements about the rollout and price of the drug.

Af­ter safe­ty re­view, EMA mir­rors FDA with up­dat­ed rec­om­men­da­tions for JAK in­hibitors

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.