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.

The site will act as a “sup­ply-chain hub” and ini­tial­ly have nine man­u­fac­tur­ing lines for pro­duc­ing med­i­cines such as tablets and cap­sules and have the abil­i­ty to sup­ply 100 mil­lion packs per year. The fa­cil­i­ty will sup­ply med­i­cines for dis­eases such as di­a­betes, high cho­les­terol and hy­per­ten­sion.

The site will al­so aim to sup­ply a mul­ti­tude of prod­ucts across Eu­rope and will have sig­nif­i­cant ware­hous­ing ca­pa­bil­i­ties.

The ul­ti­mate goal of the fa­cil­i­ty, ac­cord­ing to the Sta­da spokesper­son, is to grow the com­pa­ny’s pres­ence and strength­en the se­cu­ri­ty of med­i­cines in Eu­rope. The com­pa­ny ex­pects to start op­er­a­tions at the fa­cil­i­ty by the end of 2024 and is ex­pect­ing to hire around 375 work­ers.

The Sta­da spokesper­son al­so told End­points that fac­tors such as the pan­dem­ic and oth­er chal­lenges have shown that hav­ing a “ro­bust” med­i­cines sup­ply chain in Eu­rope is vi­tal.

“Through this ma­jor in­vest­ment, Sta­da is fur­ther strength­en­ing its com­mit­ment to act­ing as a re­li­able sup­pli­er of med­i­cines that sup­port health­care sys­tems through­out Eu­rope,” the spokesper­son said to End­points.

The site in Tur­da is al­so close to Sta­da’s test­ing lab­o­ra­to­ries in Timisoara, Ro­ma­nia, and its pro­duc­tion units in Ser­bia.

Sup­ply chain is­sues have been bear­ing down on man­u­fac­tur­ers this year as oth­er events have dis­rupt­ed the glob­al land­scape, in­clud­ing the lin­ger­ing ef­fects of Covid-19, the on­go­ing con­flict in Ukraine and ris­ing in­fla­tion.

A let­ter sent by Med­i­cines for Eu­rope, a group that rep­re­sents the gener­ic in­dus­try on the con­ti­nent, which was ad­dressed to en­er­gy min­is­ters and com­mis­sion­ers con­cern­ing in­fla­tion and the costs of en­er­gy on the sup­ply of gener­ic med­i­cines, de­tailed the hard­ships that man­u­fac­tur­ers are fac­ing. This in­cludes raw ma­te­r­i­al prices which have risen 50-160% and trans­porta­tion ris­ing to up to 500% in some cas­es.

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.