Cu­ria breaks ground on $100M ex­pan­sion project in New Mex­i­co

Last year, the CD­MO Cu­ria was ex­pand­ing clos­er to its head­quar­ters in New York state, but with help from the lo­cal gov­ern­ment, the com­pa­ny is kick­ing off a ma­jor ex­pan­sion in the Land of En­chant­ment.

Cu­ria has bro­ken ground on an ex­pan­sion project at its cam­pus in Al­bu­querque, NM. The project will see Cu­ria in­stall a new fill-fin­ish man­u­fac­tur­ing line for in­jectable med­i­cines as well as oth­er ca­pa­bil­i­ties to make and dis­trib­ute small­er-batch ad­vanced ther­a­pies.

Ac­cord­ing to the New Mex­i­co Gov­er­nor’s of­fice, Cu­ria is slat­ed to in­vest $100 mil­lion in­to its Al­bu­querque site. The State of New Mex­i­co is al­so con­tribut­ing $5 mil­lion to the project through the Lo­cal Eco­nom­ic De­vel­op­ment Act job cre­ation fund. The project is slat­ed to cre­ate 274 jobs with salaries over $50,000. The Gov­er­nor’s of­fice states that the fill-fin­ish line will be up and run­ning by 2025.

John Ratliff

“The ex­pan­sion will not on­ly pro­vide ca­reer op­por­tu­ni­ties in New Mex­i­co, but it al­so en­ables Cu­ria to make a greater con­tri­bu­tion to the pro­duc­tion of vac­cines and treat­ments, po­ten­tial­ly sav­ing mil­lions of lives lo­cal­ly, na­tion­al­ly and glob­al­ly. We ap­pre­ci­ate the sup­port and col­lab­o­ra­tion of all the or­ga­ni­za­tions rep­re­sent­ed at our ground-break­ing cel­e­bra­tion,” said Cu­ria CEO John Ratliff, in a state­ment.

The ex­pan­sion will be around 65,000 square feet and will be al­so be done in co­op­er­a­tion with sev­er­al gov­ern­ment agen­cies, in­clud­ing BAR­DA, HHS, the DoD and the US Army con­tract­ing com­mand.

Cu­ria’s site in Al­bu­querque cur­rent­ly pro­duces med­i­cines for can­cer, in­fec­tious dis­eases and oth­er rare dis­eases.

Cu­ria has al­so been on the move re­cent­ly as last year it in­vest­ed around $35 mil­lion to dou­ble the batch-size scal­ing and pack­ag­ing op­er­a­tions at its site in Rens­se­laer, NY, which will al­low the CD­MO to man­u­fac­ture APIs for new prod­ucts.

Re­cent­ly, Cu­ria tapped Niall Con­don as its pres­i­dent for its man­u­fac­tur­ing op­er­a­tions. He’s now re­spon­si­ble for the de­liv­ery of Cu­ria’s com­mer­cial man­u­fac­tur­ing ser­vices and prod­ucts, in­clud­ing APIs and oth­er drug prod­ucts.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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