A 178-acre property on a stretch of the Pittsburgh riverfront used to be the home of an old steel mill that shut down in the 1990s. Now, it will get an upgrade from a $100 million grant out of the Richard King Mellon Foundation to turn it into a bio manufacturing facility run by the University of Pittsburgh.
The site, known as Hazelwood Green, is nearly half the size of Pittsburgh’s downtown and will be transformed into a home for cell and gene therapy. It will be dubbed Pitt BioForge, and offer research teams, commercial and research partners high-tech manufacturing capabilities, a wet lab and other spaces for innovation.
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For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.
Douglas Fambrough, Dicerna CEO (Dicerna via YouTube)
Early this year researchers at Novo Nordisk were beaming as they announced the first drug identified in their RNAi alliance with Dicerna was headed into the clinic. And now they’re coming back for the whole thing.
This morning the Copenhagen-based pharma giant put out word that it is buying Dicerna $DRNA — an RNAi pioneer that has had its up and downs over the years — for $3.3 billion. Novo is paying $38.25 a share — an 80% premium.
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Gilead is going all in — hook, line and sinker — on its oncology alliance with Arcus. And they are going for broke.
The big biotech unveiled a deal that now delivers $725 million in opt-in payments covering the clinical development programs for Arcus, ranging from their closely watched anti-TIGIT programs for domvanalimab and AB308 to etrumadenant (the A2a/A2b adenosine receptor antagonist) and quemliclustat, the small molecule CD73 inhibitor. Gilead will also cover half of the development costs, handing Terry Rosen’s biotech a deal that gives them a clear cash runway to achieving all its goals in oncology.
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Thermo Fisher CEO Mark Casper
Another week, another win for the North Carolina biotech community.
This time, it’s Thermo Fisher Scientific, the Massachusetts-based contract giant, that recently announced it had plans to build a manufacturing plant. The winner is? Mebane, NC, a 15,000-person town 25 miles northwest of Durham.
The 375,000-square-foot plant at the Buckhorn Industrial Park will manufacture pipette tips for laboratory research and bioscience use. It’s a result from a $192.5 million contract with the Department of Defense that was announced back in September, in which the company pledged to increase its ability to support Covid-19 testing.
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Catherine Stehman-Breen and Vic Myer, Chroma CEO and CSO
A handful of the world’s most prominent gene editing-focused academics have been working for over a year on a new company built around a new approach for modifying DNA to treat disease. Known as Chroma Medicine, it launched on Wednesday with $125 million in early funding from Atlas, Newpath, Cormorant and several other VCs.
Chroma will focus on a markedly different way of modifying the genome than most of the gene editing biotechs that have arisen since CRISPR was pioneered nearly a decade ago. Instead of trying to erase or rewrite portions of a patient’s actual DNA — those As, Ts, Cs and Gs — Chroma will try to change the way that DNA is expressed in the cell.
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Michel Vounatsos (Biogen via YouTube)
RBC analyst Brian Abrahams is back with an update on the death of an Alzheimer’s patient on Biogen’s controversial aducanumab, and this time he says that there are solid reasons to believe that the event was likely drug related and may have been preventable.
Abrahams, a physician, notes that he obtained new information using FOIA, getting the ‘detailed case report’ about the aducanumab patient he was first to report on.
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A Belgian cell therapy company has secured $60 million in funding to strengthen its manufacturing operations, and grow the cell and gene therapy ecosystem across the world.
Ncardia landed the funding from Kiniciti, a US investment platform backed by Welsh, Carson, Anderson & Stowe, a New York City private equity company. The move gives Kiniciti a controlling stake in Ncardia to enhance anything from discovery to clinical programs to commercialized production, the company said in a press release.
Hovione executives Jean-Luc Herbeaux and Guy Villax stand in front of their booth at CPhI in Milan (Hovione PR)
Hovione is going global with its manufacturing expansion, from New Jersey all the way to Portugal.
The CDMO announced last week it would put $170 million into expansions in Portugal, Ireland and NJ, in an effort to increase its global capacity by 25%. The move follows an ongoing effort since 2016 to expand.
In a press release, COO Jean-Luc Herbeaux said:
These investments reinforce our integrated specialized offer globally, providing our clients with a line of sight for their projects. Focus is placed on facilitating and speeding up the drug development cycle and launch, by providing API manufacturing, Particle Engineering and Tableting services in each site. Our strategy continues to be to grow organically via investments in our existing sites, which are designed for purpose. This reduces the complexity associated with the growth journey and allows us to focus our management attention on what counts most, i.e. guaranteeing that our clients go to market with quality, safe and effective medicines for their patients.
The White House released early details this week on its plan to pump billions of new dollars in mRNA vaccine manufacturing to increase the number of doses abroad and prepare for the next pandemic too.
‘Importantly, initial production could provide more mRNA COVID vaccines for the world,’ coronavirus response coordinator Jeffrey Zients said Thursday at a media briefing. ‘The goal of this program is to expand existing capacity by an additional billion doses per year, with production starting by the second half of 2022.’
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