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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.

User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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