Gov. Roy Cooper was joined by Amgen executives and area politicians for a groundbreaking ceremony in Holly Springs, NC Monday.

Am­gen gets the dirt fly­ing on its new $550M man­u­fac­tur­ing site as phar­ma build­ing booms in NC

Am­gen’s big, $1 bil­lion in­vest­ment in its man­u­fac­tur­ing op­er­a­tions is of­fi­cial­ly un­der­way, as the biotech broke ground on its Hol­ly Springs, NC site Mon­day. The $550 mil­lion drug sub­stance plant is one of two mas­sive up­grades in the US for the Cal­i­for­nia com­pa­ny, and it’s look­ing to cap­i­tal­ize on the re­gion’s tal­ent­ed pool of po­ten­tial em­ploy­ees.

Wake Coun­ty and the Hol­ly Springs lo­cal gov­ern­ment award­ed Am­gen with job de­vel­op­ment grants worth $12.6 mil­lion and $22.8 mil­lion, re­spec­tive­ly, con­tin­gent up­on hir­ing mile­stones. Con­struc­tion is sched­uled to wrap up by 2029, though the plant will be op­er­a­tional in 2025. New hires will in­clude en­gi­neers, tech­ni­cians, qual­i­ty, man­age­ment and ad­min­is­tra­tive staff. The av­er­age salary of the new po­si­tions added is ex­pect­ed to reach near­ly $120,000, close to dou­ble what the cur­rent av­er­age is in Wake Coun­ty. An­oth­er 350 jobs are ex­pect­ed to be added, up­on the site’s com­ple­tion.

“Our com­mit­ment to con­tin­u­ous im­prove­ment and our sig­nif­i­cant in­vest­ments in new tech­nolo­gies have en­abled us to fur­ther ac­com­plish our mis­sion to serve pa­tients while sci­ence rapid­ly evolves,” said CEO Robert Brad­way in pre­pared re­marks. “We are de­light­ed to be build­ing our newest fa­cil­i­ty in North Car­oli­na, a ma­jor hub for bio­phar­ma­ceu­ti­cal in­no­va­tion.”

He’s not alone in ex­press­ing that sen­ti­ment.

Fu­ji­film Diosynth joined the ex­pan­sion par­ty in Hol­ly Springs in March with the an­nounce­ment of a $2 bil­lion plant of its own. A month ear­li­er, Gilead opened an of­fice for fi­nance, IT and hu­man re­sources op­er­a­tions in the area. In Jan­u­ary, Eli Lil­ly an­nounced that it would in­vest $1 bil­lion in Con­cord, NC, about 25 miles from Char­lotte, to fo­cus on in­jecta­bles and med­ical de­vices. Am­gen’s ex­pan­sion marks the 47th life sci­ences project to come to North Car­oli­na since 2017, Gov. Roy Coop­er said in an event.

“Our com­mu­ni­ty col­leges and our uni­ver­si­ties have been crit­i­cal to this,” he said at the ground­break­ing cer­e­mo­ny Mon­day. “Our biotech­nol­o­gy cen­ter is there help­ing every step of the way.”

A close prox­im­i­ty to tal­ent is part of what drew Am­gen to the area. North Car­oli­na A&T, UNC-Chapel Hill, Duke, North Car­oli­na State and Wake For­est are all with­in rough­ly an hour’s dri­ve from the cam­pus, not to men­tion a num­ber of com­mu­ni­ty col­leges and tech­ni­cal schools that call the re­gion home as well.

Am­gen is a mem­ber of the OneTen Coali­tion, made up of 35 com­pa­nies that have pledged to change the em­ploy­ment par­a­digm for Black men and women in the US. The coali­tion — whose mem­bers in­clude Whirlpool, Delta Air­lines and AirBNB — has a goal to hire 1 mil­lion Black Amer­i­cans in­to good-pay­ing jobs over the course of the next 10 years, and Am­gen says it will work with lo­cal busi­ness­es, train­ing part­ners and col­leges to help re­tain and ad­vance Black tal­ent. One of those ways will be through the Am­gen Biotech Ex­pe­ri­ence, a part­ner­ship with Re­search Tri­an­gle-area schools that pro­vides teach­ers with a hands-on biotech learn­ing ex­pe­ri­ence in their high school class­rooms.

Am­gen in­tro­duced a sim­i­lar agree­ment with Ohio State Uni­ver­si­ty to cre­ate an ex­pe­ri­en­tial learn­ing pro­gram. The deal is part of a 400-job ex­pan­sion in cen­tral Ohio to build up its pack­ag­ing op­er­a­tions, in­vest­ing $365 mil­lion 18 miles north­east of Colum­bus.

The plans for the ex­pan­sion were orig­i­nal­ly tucked in­side of the com­pa­ny’s Q2 earn­ings re­port back in Au­gust. Am­gen said that both the Hol­ly Springs and Ohio sites will be built faster and at a low­er cost than the orig­i­nal plants.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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Mar­ket­ingRx roundup: Pfiz­er, BioN­Tech re-up iHeartRa­dio hol­i­day spon­sor­ship; WHO re­names mon­key­pox to 'm­pox'

It’s that time of year again for pop music fans with the return of the iHeartRadio Jingle Ball tour — and Pfizer and BioNTech’s sponsorship. For the second year, the Covid-19 vaccine collaborators are the pharma national sponsors among consumer brand partners, including ESPN, Dunkin, M&Ms, Mercedes and Pepsi.

Pfizer and BioNTech are also sponsoring the official Jingle Ball Radio streaming station on iHeart’s network, programmed with music from past and present concert performers. This year they include Lizzo, Dua Lipa, Dove Cameron and Charlie Puth. Pfizer-sponsored radio ads and online video and digital banner ads encourage listeners to get updated Covid-19 booster shots.

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Mark Schneider, Nestlé CEO (AP Images)

Nestlé re­con­sid­ers peanut al­ler­gy pro­gram two years af­ter $2.6B buy­out

It seems Nestlé is experiencing some buyer’s remorse two years after throwing down $2.6 billion for Aimmune Therapeutics and its peanut allergy pill Palforzia.

CEO Mark Schneider announced on Tuesday that Nestlé is “exploring strategic options” for Palforzia following lower-than-expected demand. A company spokesperson declined to confirm whether a potential sale is in consideration.

“The review is expected to be completed in the first half of 2023. Going forward, Nestlé Health Science will sharpen its focus on Consumer Care and Medical Nutrition,” the company said in a news release.

Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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