Jonathan Yongwan Jo, List Bio CEO

List Bio to join In­di­ana biotech com­mu­ni­ty with $125M CMO in­vest­ment, 210 new hires

An ex­pan­sion is com­ing to the Fish­ers Life Sci­ence and In­no­va­tion Park, and with it, plans to hire an­oth­er 210 em­ploy­ees by the end of 2023.

List Bio­ther­a­peu­tics will pump $125 mil­lion in­to the project, es­tab­lish­ing a 110,000-square-foot CMO fa­cil­i­ty across 15 acres in the park. There will be both lab and of­fice space, and new em­ploy­ees will be hired for roles in bi­o­log­ics man­u­fac­tur­ing and qual­i­ty and reg­u­la­to­ry com­pli­ance.

“We’re ex­cit­ed to es­tab­lish our new man­u­fac­tur­ing op­er­a­tions in Fish­ers, a grow­ing life sci­ences hub with ac­cess to top-tier tal­ent that can sup­port our in­ter­na­tion­al ex­pan­sion. (Fish­ers) May­or (Scott) Fad­ness and his team have been in­cred­i­bly sup­port­ive through­out this process,” List pres­i­dent and CEO Jonathan Yong­wan Jo said in a press re­lease. “Our ob­jec­tive with the in­vest­ment for this new fa­cil­i­ty is to man­u­fac­ture live bio­ther­a­peu­tic prod­ucts for Phase III clin­i­cal tri­als and for com­mer­cial use.”

The new fa­cil­i­ty will of­fer end-to-end man­u­fac­tur­ing so­lu­tions from ear­ly-stage de­vel­op­ment to late-stage clin­i­cal tri­als and com­mer­cial­iza­tion. List Labs, List Bio’s sis­ter com­pa­ny, re­cent­ly got an in­vest­ment from Genome, the South Ko­re­an-based par­ent com­pa­ny, who be­came a ma­jor­i­ty share­hold­er.

List Labs was found­ed in Cal­i­for­nia by Lin­da Shoer in the mid-1970s. When she died in 1999, she left it to her two sis­ters. The live bio­ther­a­peu­tics are be­ing de­vel­oped to tar­get gut, der­ma­to­log­ic, neu­ro­log­ic, re­pro­duc­tive and on­co­log­ic dis­or­ders.

The com­pa­ny will land up to $3.15 mil­lion in in­cen­tive-based tax cred­its from the In­di­ana Eco­nom­ic De­vel­op­ment Cor­po­ra­tion, based up­on List’s job cre­ation plans. It will al­so re­ceive $75,000 in train­ing grants and up to $1.6 mil­lion for in­fra­struc­ture im­prove­ments. Those in­cen­tives will be vot­ed up­on by the city coun­cil lat­er in No­vem­ber.

“This is a tremen­dous de­vel­op­ment for In­di­ana’s life sci­ences sec­tor, the City of Fish­ers, and the State,” said Bri­an Stemme, the SVP of en­gage­ment for BioCross­roads, an or­ga­ni­za­tion fo­cused on grow­ing the In­di­ana’s life sci­ences in­dus­try. “Genome makes key com­po­nents for biotech prod­ucts in de­vel­op­ment all over the world. It’s a tes­ta­ment to our ex­pe­ri­enced work­force and strength in phar­ma­ceu­ti­cal man­u­fac­tur­ing that this glob­al play­er is in­vest­ing in our re­gion.”

In Oc­to­ber, Ital­ian man­u­fac­tur­er Ste­vana­to broke ground on a $145 mil­lion fa­cil­i­ty in a move aimed at bring­ing op­er­a­tions clos­er to its US cus­tomers. That build­ing will be 370,000 square-feet, help re­duce its drug’s time to mar­ket, low­er the cost of own­er­ship and re­duce sup­ply chain risk. That com­pa­ny de­buted on the New York Stock Ex­change in Ju­ly with a val­u­a­tion of $5 bil­lion.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.