Governor John Carney, Lieutenant Governor Bethany Hall-Long, Mayor Kenneth Branner, Jr., Delaware Prosperity Partnership President Kurt Foreman, WuXi AppTec Chairman and CEO Ge Li, WuXi AppTec Co-CEO and WuXi STA CEO Minzhang Chen, and others celebrate the groundbreaking for the WuXi STA Middletown campus.

WuXi STA breaks ground on Delaware fa­cil­i­ty, boost­ing its US pres­ence

While Mid­dle­town, Delaware’s main claim to fame was the site lo­ca­tion for the film the Dead Po­ets So­ci­ety, the city will soon play host to a mas­sive man­u­fac­tur­ing out­fit.

WuXi AppTec’s con­tract re­search and man­u­fac­tur­ing sub­sidiary WuXi STA, has bro­ken ground on a 190-acre man­u­fac­tur­ing cam­pus in Mid­dle­town.

Ac­cord­ing to the com­pa­ny, this site will be WuXi’s sec­ond fa­cil­i­ty in the US, and it will cre­ate around 500 full-time jobs by 2026, but there are plans to kick off op­er­a­tions in 2025.

A re­port from the Delaware Bio­Science As­so­ci­a­tion said WuXi paid $30 mil­lion for the land with the site cost­ing a to­tal of $510 mil­lion. The site is al­so backed by $19 mil­lion in tax­pay­er-fund­ed grants.

The com­pa­ny states that this is the first phase of the new cam­pus. While it did not pro­vide in­for­ma­tion on what ex­act prod­ucts will be man­u­fac­tured once com­plet­ed, the site will be able to pro­vide for­mu­la­tion de­vel­op­ment and clin­i­cal and com­mer­cial drug prod­uct man­u­fac­tur­ing ser­vices for oral and in­jectable prod­ucts. The site will al­so be able to pack­age, la­bel, store and dis­trib­ute ser­vices for clin­i­cal tri­al ma­te­ri­als and com­mer­cial drug prod­ucts.

“WuXi STA con­tin­ues to in­crease our ca­pa­bil­i­ties and ca­pac­i­ties to bet­ter serve our cus­tomers through a more ro­bust and re­li­able sup­ply chain. With our in­te­grat­ed Con­tract Re­search, De­vel­op­ment, and Man­u­fac­tur­ing Or­ga­ni­za­tion (CRD­MO) plat­form and proven qual­i­ty sys­tem, we look for­ward to work­ing with our cus­tomers to swift­ly de­liv­er their in­no­v­a­tive ther­a­pies to mar­ket in or­der to save lives and im­prove health­care for pa­tients,” said WuXi CEO Minzhang Chen in a state­ment.

The com­pa­ny said in an email to End­points News that Delaware was cho­sen be­cause the state has a grow­ing health­care in­dus­try as well as a high­ly trained phar­ma man­u­fac­tur­ing work­force.

While the com­pa­ny al­so did not go in­to de­tails about any fu­ture build­ing phas­es, when the site was an­nounced in 2021, the com­pa­ny said the site could ex­pand to hire more than 1,000 em­ploy­ees, with 600,000 square feet of space in at least three build­ings, in­clud­ing one for drugs, one for ad­min­is­tra­tion, and one for drug sub­stances.

While WuXi finds it­self in good com­pa­ny with com­pa­nies such as As­traZeneca and Charles Riv­er in Delaware, the com­pa­ny has been look­ing to ex­pand rapid­ly across the globe.

This year the com­pa­ny has opened an HPA­PI plant at its Changzhou site in Jiang­su, Chi­na, and two large-scale oligonu­cleotide and pep­tide man­u­fac­tur­ing fa­cil­i­ties at its cam­pus in Changzhou, Chi­na. Last year the com­pa­ny ac­quired Bris­tol My­ers Squibb’s site in Cou­vet, Switzer­land, which spe­cial­izes in com­mer­cial-scale pro­duc­tion of var­i­ous cap­sules and tablet dosage forms.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Deborah Waterhouse, ViiV Healthcare CEO

MPP re­cruits three gener­ic man­u­fac­tur­ers to ex­pand use of Vi­iV's in­jectable PrEP drug

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.

Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.