Man­u­fac­tur­ing roundup: WuXi STA un­veils new fa­cil­i­ty; Pur­due Uni­ver­si­ty nets $3M grant for ze­ro-waste phar­ma man­u­fac­tur­ing

CD­MO WuXi STA has been on the move re­cent­ly by break­ing ground on a fa­cil­i­ty in the US, and the com­pa­ny is show­ing no signs of stop­ping its ex­pan­sion dri­ve.

The com­pa­ny an­nounced that it has opened a new ster­ile lipid nanopar­ti­cle man­u­fac­tur­ing site at its cam­pus in the city of WuXi, Chi­na. The fa­cil­i­ty has a mod­u­lar lay­out, al­low­ing for flex­i­bil­i­ty in the man­u­fac­tur­ing process, and can pro­duce 10 to 50 liters per batch.

“We are pleased to sup­port our part­ners with this state-of-the-art LNP fa­cil­i­ty to meet the grow­ing de­mand for ad­vanced in­jec­tion dosage forms. We will con­tin­ue to ex­pand our CRD­MO plat­form’s ca­pac­i­ty and ca­pa­bil­i­ties to en­able our part­ners to ac­cel­er­ate more in­no­v­a­tive drugs to mar­ket for pa­tients world­wide,” said WuXi STA CEO Minzhang Chen in a state­ment.

Pur­due Uni­ver­si­ty team nets grant to in­ves­ti­gate more sus­tain­able phar­ma­ceu­ti­cal man­u­fac­tur­ing

Re­searchers at Pur­due Uni­ver­si­ty have se­cured a $3 mil­lion grant from the Na­tion­al Sci­ence Foun­da­tion to in­ves­ti­gate cost-ef­fec­tive, ze­ro-waste ini­tia­tives for phar­ma man­u­fac­tur­ing op­er­a­tions.

Ac­cord­ing to the uni­ver­si­ty, cur­rent man­u­fac­tur­ing can cre­ate a sig­nif­i­cant amount of un­used med­i­cines and tox­ic waste, caus­ing en­vi­ron­men­tal dam­age and re­duc­ing man­u­fac­tur­ers’ prof­its.

“Our project is fo­cused on cre­at­ing a large-scale frame­work and cy­ber­in­fra­struc­ture that can help man­u­fac­tur­ing net­works to per­form more sus­tain­ably. We’ll start our proof of con­cept with the phar­ma­ceu­ti­cal in­dus­try, giv­en its high im­pact on the Amer­i­can man­u­fac­tur­ing sys­tem dur­ing Covid,” said Shwe­ta Singh, project leader and as­so­ciate pro­fes­sor of Agri­cul­tur­al and Bi­o­log­i­cal En­gi­neer­ing and En­vi­ron­men­tal and Eco­log­i­cal En­gi­neer­ing, in a state­ment.

The project will aim to build a “cir­cu­lar econ­o­my de­sign com­pu­ta­tion­al tool,” which will help com­pa­nies reuse re­sources while al­so re­duc­ing the flow of waste, and stands in stark con­trast to the more lin­ear forms of pro­duc­tion in the in­dus­try.

The mod­el has al­ready been test­ed in agrar­i­an-based set­tings, and Singh’s team is work­ing with part­ners in the in­dus­try to de­vel­op and test the al­go­rithms.

The team will al­so work to de­vel­op a pric­ing al­go­rithm as well for the re­cy­cling of waste med­i­cines for man­u­fac­tur­ing.

Ori Biotech part­ners up with Re­silience and MD An­der­son joint ven­ture

The joint ven­ture be­tween Re­silience and MD An­der­son to cre­ate a man­u­fac­tur­ing site for cell ther­a­pies has pulled in a new part­ner.

Man­u­fac­tur­ing tech­nol­o­gy com­pa­ny Ori Biotech has part­nered up with the Cell Ther­a­py Man­u­fac­tur­ing Cen­ter (CTMC), the joint ven­ture that aims to cre­ate new cell ther­a­pies to fight can­cer. The col­lab­o­ra­tion will set its sights on in­dus­tri­al man­u­fac­tur­ing process­es for cell ther­a­pies.

Ac­cord­ing to Ori, the part­ner­ship will in­clude com­bin­ing its tech­nol­o­gy plat­form with the man­u­fac­tur­ing cen­ter’s ca­pa­bil­i­ties. While the part­ner­ship has ze­roed in on work­ing on one cell ther­a­py now, it plans to work on oth­er Car-T process­es and de­ter­mine its “tech­ni­cal fea­si­bil­i­ty.”

The part­ner­ship will al­so al­low the CTMC to gain pre-com­mer­cial ac­cess to Ori’s tech­nol­o­gy.

“Ori and CTMC have specif­i­cal­ly part­nered with the goal of in­creas­ing pa­tient ac­cess to po­ten­tial­ly life-sav­ing cell ther­a­pies. This part­ner­ship will have a con­sid­er­able im­pact on the cell ther­a­py field by im­ple­ment­ing in­no­v­a­tive, dig­i­tal­ly en­abled process dis­cov­ery and au­to­mat­ed man­u­fac­tur­ing so­lu­tions,” said Ja­son Fos­ter, Ori Biotech’s CEO, in a state­ment.

Man­u­fac­tur­er ac­quired by Sin­ga­pore-based pri­vate eq­ui­ty firm

Ever­stone Cap­i­tal has ac­quired a con­trol­ling stake in the man­u­fac­tur­ing com­pa­ny Soft­gel Health­care. Soft­gel, an In­di­an-based dosage form man­u­fac­tur­ing op­er­a­tion, cre­ates over-the-counter phar­ma­ceu­ti­cal prod­ucts — main­ly pro­bi­otics and soft gelatin cap­sules.

Ac­cord­ing to Sin­ga­pore-based Ever­stone Cap­i­tal, the ac­qui­si­tion will aim to build up Soft­gel and pro­vide the com­pa­ny with more re­sources. The fi­nan­cial terms of the deal were not dis­closed.

Soft­gel, part of the Madras Phar­ma Group, al­so main­tains eight man­u­fac­tur­ing sites and R&D op­er­a­tions.

“The com­pa­ny, with its strong R&D ca­pa­bil­i­ties and abil­i­ty to man­u­fac­ture prod­ucts in ad­vanced dosage forms, is well po­si­tioned to be a glob­al leader in the CD­MO seg­ment. We be­lieve that Ever­stone’s val­ue cre­ation play­book will help SH­PL re­al­ize its glob­al goals and pro­pel the com­pa­ny in­to its next phase of growth,” said Sameer Sain, Ever­stone Group CEO in a state­ment.

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

Sanofi re­news so­cial cam­paign to re­mind that vac­cines let peo­ple ‘Dream Big’

Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

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