Eli Lil­ly un­veils an $850M makeover as Trump pounds the ta­ble for new US jobs, man­u­fac­tur­ing

David Ricks, Lil­ly

Eli Lil­ly has a present for Pres­i­dent Trump. At a time Trump has been pound­ing on big com­pa­nies in gen­er­al and Big Phar­ma in spe­cif­ic for more US jobs and de­vel­op­ment, Eli Lil­ly is launch­ing an $850 mil­lion ren­o­va­tion plan for its US fa­cil­i­ties.

The In­di­anapo­lis-based Lil­ly un­veiled a blue­print to in­vest in its re­search labs, man­u­fac­tur­ing ops and its head­quar­ters in In­di­ana.

“Our fu­ture at Lil­ly is bright, as we’re on a path to launch 20 new prod­ucts in a 10-year time frame,” Lil­ly CEO Dave Ricks said. “As we have for our en­tire 140-year his­to­ry, we con­tin­ue to see In­di­ana and the Unit­ed States as at­trac­tive places to re­search and make the med­i­cines that we sell around the world.”

That mes­sage will sell well in Wash­ing­ton, DC.

The new projects in­clude an $85 mil­lion ex­pan­sion of its Trulic­i­ty (du­laglu­tide) de­vice as­sem­bly op­er­a­tions in the US, which should al­so help ap­pease Trump, who’s been par­tic­u­lar­ly fo­cused on bring­ing man­u­fac­tur­ing jobs “back” to the US. And Ricks hit hard on the new con­struc­tion jobs that would be cre­at­ed in 2017 as they pushed ahead with the cap­i­tal project.

Ricks may have found him­self out of step with the tenor and times in Wash­ing­ton DC ear­li­er this year, as the com­pa­ny fo­cused on trim­ming its staff. In ear­ly Feb­ru­ary, just weeks af­ter un­veil­ing plans to lay off 485 staffers that had been in­volved in the failed solanezum­ab pro­gram, the com­pa­ny spread word that it was look­ing for 200 re­searchers to take a “vol­un­tary ex­it.”

While Lil­ly spends a rel­a­tive­ly large por­tion of its rev­enue on R&D, for­mer CEO John Lech­leit­er al­ways made a point of keep­ing a care­ful han­dle on spend­ing over­all. And that in­clud­ed hir­ing.

At the end of 2015, Eli Lil­ly em­ployed 41,275 peo­ple, in­clud­ing ap­prox­i­mate­ly 23,425 em­ploy­ees out­side the US. But it’s al­so been ship­ping jobs over­seas. Five years ear­li­er Lil­ly em­ployed 40,360 peo­ple, in­clud­ing ap­prox­i­mate­ly 20,300 em­ploy­ees out­side the Unit­ed States.

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.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Doug Williams, departing Codiak BioSciences CEO

Co­di­ak files for Chap­ter 11 bank­rupt­cy as most ex­ec­u­tives head for the ex­it

Codiak BioSciences has filed for Chapter 11 bankruptcy, spelling an end to the employment of most executives, including founder Doug Williams, as the biotech says it “expects to consummate a sale.”

The eight-year journey at Codiak is nearing an end with Williams; CFO Linda Bain; medical chief David Mauro; scientific head Sriram Sathyanarayanan; legal and compliance chief Yalonda Howze; and SVP of HR Nicole Barna all packing up their bags in the first few days of April. Chief technology officer Konstantin Konstantinov will stay.

Ap­plied Mol­e­c­u­lar Trans­port pre­pares to close up shop as it paus­es R&D, re­places CEO, lays off 57%

Applied Molecular Transport is preparing to put up a “for sale” sign, less than a year after its last corporate reorg.

The California biotech said Monday that it would halt all R&D activities and hunt for “strategic alternatives.” In addition, CEO Tahir Mahmood left his position last Friday, a few days after the board laid off 35 employees across the company. COO Shawn Cross has been elevated to the CEO seat, according to SEC documents.

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Es­pe­ri­on sues Dai­ichi Sankyo, de­mand­ing pay­ment of $300M mile­stone for car­dio drug

Esperion is suing its business partner Daiichi Sankyo, saying the Japanese drugmaker is improperly refusing to pay a $300 million milestone that the biotech company will be owed after reporting positive data from a large trial of its cardiovascular drug Nexletol.

The 2019 deal between the companies had Daiichi Sankyo pay $150 million upfront plus another $150 million after the first sales of the drug. But another major payout was tied to an outcomes study reported this month, known as CLEAR. Esperion, in its suit against Daiichi, argues that the drug’s more than 20% reduction of heart attack risk is enough to trigger a $300 million payout from Daiichi once it’s added to the drug’s label.

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