Pfiz­er will in­vest $1.2B+ in Irish man­u­fac­tur­ing site, adding 500 em­ploy­ees

Covid-19 trail­blaz­er Pfiz­er has con­firmed its com­mit­ment to a large ex­pan­sion project on the Emer­ald Isle.

The New York-based com­pa­ny an­nounced on Thurs­day that it will make a €1.2 bil­lion ($1.26 bil­lion) cap­i­tal in­vest­ment in­to its man­u­fac­tur­ing site at Grange Cas­tle in Dublin.

The ex­pan­sion of the site marks Pfiz­er’s largest ex­pan­sion in­vest­ment in Ire­land to date. The ex­pan­sion in­cludes the con­struc­tion of a new fa­cil­i­ty on the premis­es as well as adding in more lab­o­ra­to­ry space and will ul­ti­mate­ly dou­ble the ca­pac­i­ty for “bi­o­log­i­cal drug sub­stance man­u­fac­tur­ing” in the on­col­o­gy and rare dis­ease space as well as in­flam­ma­tion, im­munol­o­gy and in­ter­nal med­i­cines.

The project is cur­rent­ly in the “pre­lim­i­nary de­sign phase,” and con­struc­tion is slat­ed to start in 2024, with com­ple­tion com­ing in 2027. Pfiz­er an­tic­i­pates around 400-500 em­ploy­ee roles will be added, bring­ing its to­tal num­ber of em­ploy­ees in the coun­try to around 5,500.

This is not the first move that Pfiz­er has made at Grange Cas­tle as last year it in­vest­ed €40 mil­lion ($42.1 mil­lion) in­to the site to bring it in­to Pfiz­er’s Covid-19 man­u­fac­tur­ing net­work, adding around 75 jobs as well. The site, along with three oth­er man­u­fac­tur­ing fa­cil­i­ties in Ire­land, cur­rent­ly pro­duces med­i­cines and vac­cines for arthri­tis, in­flam­ma­tion, pain, can­cer and an­ti-in­fec­tives, among oth­ers.

Mike Mc­Der­mott

Mike Mc­Der­mott, the chief glob­al sup­ply of­fi­cer at Pfiz­er, said in a state­ment:

Grange Cas­tle has played a crit­i­cal role in our glob­al Covid-19 vac­cine net­work, and this in­vest­ment for non-Covid li­censed and pipeline prod­ucts will help fur­ther to ex­pand the site’s broad and ro­bust ca­pa­bil­i­ties. As this in­vest­ment demon­strates, we con­tin­ue to in­vest in our glob­al man­u­fac­tur­ing in­fra­struc­ture to strive to bring much-need­ed med­i­cines and vac­cines to pa­tients, around the world, and to de­liv­er the next sci­en­tif­ic break­throughs.

Pfiz­er has been on a man­u­fac­tur­ing ex­pan­sion through­out the year as it con­firmed in June it will be spend­ing around $120 mil­lion on its own for its 1,300-acre man­u­fac­tur­ing fa­cil­i­ty in Kala­ma­zoo, MI, to en­able wider pro­duc­tion of its Covid-19 oral an­tivi­ral Paxlovid.

And a Bloomberg re­port from the sum­mer al­so said that Pfiz­er will spend $470 mil­lion to ex­pand its vac­cine re­search fa­cil­i­ties at its lo­ca­tion in Pearl Riv­er, NY. Pfiz­er will look to con­struct a new build­ing as well as ren­o­vate ex­ist­ing fa­cil­i­ties on the cam­pus.

Ire­land has been a ma­jor cen­ter of ac­tiv­i­ty for ex­pan­sions in the man­u­fac­tur­ing field this year too, with some big names look­ing to com­mit a large amount of mon­ey to­ward projects.

More re­cent­ly, Ipsen, J&J and Ab­b­Vie an­nounced they were spend­ing eight or nine fig­ures worth of funds on ex­pan­sion projects there.

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

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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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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.

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.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.