Marc Casper, Thermo Fisher CEO

Ther­mo Fish­er com­pletes $76M cell cul­ture man­u­fac­tur­ing site near Buf­fa­lo, NY

Ther­mo Fish­er has com­plet­ed the ex­pan­sion of one of its man­u­fac­tur­ing fa­cil­i­ties in New York, tak­ing an­oth­er step for­ward in its broad­er in­vest­ment plan for sites in the US and glob­al­ly.

The $76 mil­lion ex­pan­sion of its dry pow­der me­dia man­u­fac­tur­ing fa­cil­i­ty in Grand Is­land, New York, just north of Buf­fa­lo, will al­low more ca­pac­i­ty to sup­port Ther­mo Fish­er’s glob­al sup­ply and ex­tend its ca­pa­bil­i­ties for ma­te­ri­als used in vac­cines and bi­o­log­ic ther­a­py de­vel­op­ment and man­u­fac­tur­ing.

The Grand Is­land ex­pan­sion was an­nounced ear­li­er last year as part of the com­pa­ny’s $650 mil­lion in­vest­ment in­to sev­er­al in­fra­struc­ture projects to in­crease its bio­pro­cess­ing pro­duc­tion. That in­vest­ment in­cludes site ex­pan­sions across the US, UK, Sin­ga­pore and Chi­na.

“Our ex­pand­ed Grand Is­land site rep­re­sents a sig­nif­i­cant mile­stone in our in­vest­ment to dou­ble our to­tal man­u­fac­tur­ing ca­pac­i­ty by the end of 2023. With the har­mo­nized ca­pa­bil­i­ties of our glob­al man­u­fac­tur­ing sites that en­able us to prove equiv­a­len­cy in man­u­fac­tur­ing, we’re able to sup­port cur­rent de­mand while prim­ing for fu­ture growth and con­tin­u­ous­ly en­hanc­ing our cus­tomer ex­pe­ri­ence glob­al­ly,” said Kate Torchilin, pres­i­dent of bi­o­log­i­cals and chem­i­cals at Ther­mo Fish­er, in a state­ment.

The ex­pan­sion adds more than 45,000 square feet of man­u­fac­tur­ing space for the pro­duc­tion of Gib­co Ad­vanced Gran­u­la­tion Tech­nol­o­gy (AGT) and dry pow­der me­dia as well as cell cul­tures and liq­uid sup­ple­ments.

Ac­cord­ing to the com­pa­ny, the ad­di­tion­al space will al­so help ac­cel­er­ate the de­vel­op­ment and pro­duc­tion of bio­ther­a­peu­tics and vac­cines, and al­low process ca­pa­bil­i­ties and equip­ment to pro­vide pro­duc­tion re­dun­dan­cy and short­en prod­uct man­u­fac­tur­ing lead times.

The Grand Is­land ex­pan­sion is ex­pect­ed to add 100 em­ploy­ees across roles in R&D, op­er­a­tions, man­u­fac­tur­ing, HR, en­gi­neer­ing and main­te­nance. Ther­mo Fish­er cur­rent­ly em­ploys more than 1,600 peo­ple at the Grand Is­land site and more than 3,000 peo­ple across the state of New York.

Ac­cord­ing to Ther­mo Fish­er, the site has been in op­er­a­tion for more than 60 years and home to Gib­co cell prod­ucts, which are wide­ly used in bio­man­u­fac­tur­ing world­wide.

Ear­li­er this year Ther­mo Fish­er opened a $44 mil­lion fa­cil­i­ty in Og­den, Utah, that will man­u­fac­ture high­ly cus­tomiz­able bio­process con­tain­er sys­tems as a part of the spend­ing spree.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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Josep Bassaganya-Riera, NImmune Biopharma

Ex­clu­sive: Af­ter get­ting his drug back, Lan­dos founder as­sem­bles new start­up for the big PhI­II test

By the time Josep Bassaganya-Riera stepped down as founding CEO of Landos Biopharma in 2021, the company had racked up Phase II data for its top autoimmune program, completed what he called a positive end-of-Phase-II meeting with the FDA and plans to launch pivotal Phase III trials.

Since then, though, the new leaders at Landos have reshuffled their plans for the drug, omilancor, first announcing they will run a Phase IIb ahead of a Phase III and eventually shelving it altogether.

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Lars Fruergaard Jørgensen, Novo Nordisk CEO (Photographer: Christopher Goodney/Bloomberg via Getty Images)

Most dos­es of No­vo Nordisk's Ozem­pic are re­moved from FDA drug short­age list af­ter sup­ply is­sues

Novo Nordisk’s type 2 diabetes treatment Ozempic, which is also used off-label for weight loss, is back in stock following a months-long shortage, according to the FDA’s drug shortages list.

The FDA updated its website on Friday to show that Ozempic’s 0.25 mg, 0.5 mg and 1 mg doses are now available across the US. The 0.25 mg and 0.5 mg doses suffered limited supply for the last few months, according to a Novo Nordisk spokesperson. However, the 2 mg dose has “limited availability and may not fully meet demand until the end of this month,” the company told Endpoints News on Monday.

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