Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image:

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A man­u­fac­tur­ing site that has re­ceived in­ter­est and in­vest­ments from large phar­ma com­pa­nies and the UK gov­ern­ment is open­ing its doors in Scot­land.

The man­u­fac­tur­er CPI (Cen­tre for Process In­no­va­tion) has opened a new £88 mil­lion ($105 mil­lion) “Med­i­cines Man­u­fac­tur­ing In­no­va­tion Cen­tre” in Glas­gow, Scot­land, to ac­cel­er­ate the de­vel­op­ment of man­u­fac­tur­ing tech and solve long­stand­ing chal­lenges in med­i­cine de­vel­op­ment and man­u­fac­tur­ing.

Ac­cord­ing to CPI, the new site is a col­lab­o­ra­tion be­tween the com­pa­ny and 24 oth­er part­ner or­ga­ni­za­tions in phar­ma, acad­e­mia and gov­ern­ment. The site al­so has found­ing part­ners that in­clude GSK, As­traZeneca, the Uni­ver­si­ty of Strath­clyde, and two UK gov­ern­ment agen­cies: UK Re­search and In­no­va­tion and the Scot­tish En­ter­prise, which in­vest­ed £16 mil­lion ($19.1 mil­lion). Oth­er in­vest­ment part­ners in­clude names such as No­var­tis, Pfiz­er, Al­ny­lam, PwC and Siemens, among oth­ers.

UK Gov­ern­ment Min­is­ter for Scot­land John La­m­ont said that £28 mil­lion ($33.4 mil­lion) was giv­en to the fa­cil­i­ty by the UK Gov­ern­ment, through In­no­vate UK.

The site is us­ing what CPI calls a “grand chal­lenge” mod­el that com­bines ideas from both the phar­ma and tech­nol­o­gy sec­tors to at­tack is­sues such as de­vel­op­ing more sus­tain­able man­u­fac­tur­ing process­es.

CPI al­so said that the new site is fore­cast­ed to gen­er­ate £200 mil­lion ($238.6 mil­lion) in ad­vanced man­u­fac­tur­ing tech­nolo­gies over the first five years of op­er­a­tion and cre­ate around 100 jobs as well. The site will al­so plan to take on “start-up risks” that are in­volved with drug de­vel­op­ment, such as com­pli­ance with the reg­u­la­to­ry re­quire­ments for the de­vel­op­ment of new tech.

Dave Tu­dor, the man­ag­ing di­rec­tor of med­i­cines man­u­fac­tur­ing, bi­o­log­ics and qual­i­ty at CPI, said in a state­ment:

Our ‘Grand Chal­lenge’ busi­ness mod­el aims to bring key play­ers to­geth­er to ac­cel­er­ate so­lu­tions to some of the core is­sues we’ve seen across the in­dus­try. For ex­am­ple, we want to see a re­duc­tion in waste and the in­dus­try’s car­bon foot­print through bet­ter, more ef­fi­cient man­u­fac­tur­ing process­es. We want to dri­ve strong re­search in ar­eas like cell and gene ther­a­py, RNA and mon­o­clon­al an­ti­bod­ies, to bring dig­i­tal so­lu­tions, ad­vanced think­ing, ad­vanced tech­nol­o­gy and ad­vanced sup­ply chain mind­sets to help with greater in­vest­ment and growth in bi­o­log­i­cal man­u­fac­ture.

CPI’s new man­u­fac­tur­ing site is com­ing on­line at a time when larg­er phar­mas and CD­MOs are kick­ing off new projects in the coun­try.

Charles Riv­er cut the rib­bon on a new 16,000-square-foot fa­cil­i­ty in Cheshire, UK that will pro­duce plas­mids to be used in cell and gene ther­a­pies.

Mod­er­na will be look­ing to es­tab­lish a vac­cine re­search cen­ter and a man­u­fac­tur­ing site for a se­ries of vac­cines, the UK gov­ern­ment an­nounced in the sum­mer, and will es­tab­lish a new mR­NA In­no­va­tion and Tech­nol­o­gy Cen­tre to de­vel­op mR­NA vac­cines for a wide range of res­pi­ra­to­ry dis­eases, in­clud­ing Covid-19.

And Fu­ji­film’s CD­MO arm, Fu­ji­film Diosynth, start­ed a 20,000 square-foot, £400 mil­lion ($435 mil­lion) ex­pan­sion project for its mi­cro­bial man­u­fac­tur­ing fa­cil­i­ty at its cam­pus in the town of Billing­ham, UK, in the north­east of Eng­land.

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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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.