Vas Narasimhan tapped to take No­var­tis' helm as Joe Jimenez heads to Sil­i­con Val­ley

Vas­ant Narasimhan, No­var­tis

⇨ No­var­tis an­nounced Mon­day that Joe Jimenez is step­ping down in Feb­ru­ary and hand­ing the reins over to 41-year-old Vas Narasimhan, an ex­u­ber­ant ad­vo­cate of cut­ting-edge sci­ence who’s been mak­ing his mark with a slate of suc­cess­ful pro­grams for the com­pa­ny’s next wave of block­buster drugs. Narasimhan is now join­ing one of the most ex­clu­sive clubs in bio­phar­ma — CEO of a bio­phar­ma or­ga­ni­za­tion with ac­tiv­i­ties that span the globe. In nam­ing him CEO, the Basel-based com­pa­ny is keep­ing an Amer­i­can at the top. But in­stead of the mar­ket­ing or le­gal back­ground of most of his peers, Narasimhan brings ex­pe­ri­ence in new prod­uct de­vel­op­ment. Jimenez, mean­while, has his eye on a place in Sil­i­con Val­ley.

⇨ Clau­dio Al­brecht was se­lect­ed as the in­ter­im CEO to run Sta­da as it tran­si­tions to a pri­vate com­pa­ny and then lo­cates a per­ma­nent re­place­ment. Al­brecht ad­vised Bain and Cin­ven as they were bid­ding for the com­pa­ny.

⇨ Mor­gan Mol­loy is join­ing En­zy­vant to serve as chief com­mer­cial of­fi­cer. He held that same po­si­tion pre­vi­ous­ly at Spark Ther­a­peu­tics, and al­so spent some time at Sanofi, Al­ler­gan and Bio­gen.

⇨ Tom Graney is jump­ing ship at Iron­wood and mov­ing over to Ver­tex as its new CFO.

⇨ Ovid Ther­a­peu­tics has ap­point­ed Ana C. Ward as SVP and gen­er­al coun­sel.

⇨ Io­n­is spin­out Akcea has been build­ing up its ex­ec­u­tive team in prepa­ra­tion for its first com­mer­cial launch. The new team mem­bers in­clude: Michael MacLean, chief fi­nan­cial of­fi­cer; Mustafa Noor, chief de­vel­op­ment of­fi­cer; Samuel Yon­ren, vice pres­i­dent and head of phar­ma­covig­i­lance and drug safe­ty; and Kyle Jenne, US com­mer­cial head.

⇨ AM­AG Phar­ma­ceu­ti­cals named Lau­ra Williams as se­nior vice pres­i­dent of clin­i­cal de­vel­op­ment.

⇨ Opi­ant Phar­ma­ceu­ti­cals tapped David O’Toole as its new chief fi­nan­cial of­fi­cer. O’Toole just left his post as CFO at Soleno Ther­a­peu­tics. The biotech says that he will be re­placed by Jonathan R. Wolter on an in­ter­im ba­sis as they hunt for a per­ma­nent re­place­ment.

 

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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Ex­clu­sive: Cell ther­a­py biotech brings on Loxo vet amid glob­al ex­pan­sion plans; Re­tire­ment beck­ons for Vir's George Scan­gos

Bree Harlin, who used to be director of clinical operations at Loxo Oncology, now Loxo@Lilly, is now in the C-suite for the first time.

Harlin started at TC BioPharm on Wednesday as chief clinical officer, the biotech announced Friday — but her journey starts more than 20 years before then. After graduating from college, she moved to Boston, working in academia at some of the Harvard teaching hospitals in endocrinology and CNS.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.