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Amgen opens AI-enabled Ohio biomanufacturing facility

CEO Bob Bradway rallies the manufacturing team at Amgen Ohio with a chant of “OH-IO.”

Earlier this year, NVIDIA and Amgen revealed plans to analyze one of the world’s largest human datasets using AI models trained on an NVIDIA DGX SuperPOD in Iceland. Now, Amgen is signaling its continued commitment to cutting-edge tech with a ribbon cutting for an advanced biomanufacturing facility in New Albany, Ohio.

Known as Amgen Ohio, the facility is designed to uphold the company’s reputation for quality and reliability. It will play a significant role in producing innovative biomedicines to address serious diseases, employing approximately 400 people across various roles.

The new facility “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,’” said Bob Bradway, chairman and chief executive officer at Amgen.

Amge…

Inside Amgen’s ATOMIC strategy to use ML to accelerate clinical trials

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Amgen has developed a machine learning platform to slash clinical trial times through smarter site selection. Known as ATOMIC, short for Analytical Trial Optimization Module, the system crunches disparate datasets to predict optimal trial locations, expedite enrollment and trial processes. Early results indicate more than a two times increase in enrollment speed at ATOMIC sites.

ML-powered clinical trial oracle could compress clinical trial cycle time

“With the massive amounts of data we’re pulling from various sources, we anticipate that by 2030, we’ll be able to shave about two years off the development times for our drugs,” said Sheryl Jacobs, vice president, global Development operations at Amgen. For now, the company is steadily ramping up the number of trials using the ATOMIC process. “Within the next year or two, we expect the majority of our trials will be using the AI …

Amgen, Deepcell tap NVIDIA’s AI to drive drug discovery and advance cell morphology research

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In 2023, generative AI (GenAI) entered the mainstream, capturing the attention of both the public and a growing number of biotechs. One of the most prominent Big Tech firms driving the trend is NVIDIA, which has forged alliances with biotechs ranging from Genentech, Recursion Pharmaceuticals and Evozyne, among others.

The momentum is continuing in early 2024, with NVIDIA announcing renewed pacts with Amgen and DeepCell. Amgen will use NVIDIA’s drug discovery generative AI platform BioNeMo Cloud service to accelerate molecule screening and optimization processes. Meanwhile, NVIDIA’s partnership with Deepcell hinges on advancing cell morphology studies with generative AI. “There is a very big moment happening in the world of pharmaceuticals and how drugs are being discovered,” said Kimberly Powell, vice president of Healthcare at NVIDIA, in a call with journali…

Pharma M&A activity primed for another high-flying year in 2024

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Despite challenging interest rates and regulatory environment, pharma M&A activity surged in 2023 with deal volume up more than 30% from the prior year based on a review of more than 200 acquisitions since 2018. The total disclosed deal value in 2023 also more than doubled the prior year’s tally to surpass $100 billion. While the pandemic boosted research into areas such as mRNA, it had something of a chilling effect on M&A. As pharma companies begin to put the pandemic in the rearview mirror, M&A activity has gained momentum.

Analysts upbeat on biopharma M&A activity in 2024

According to PwC, the M&A activity in the pharmaceutical and life sciences sector could continue humming in 2024. Despite a challenging interest rate environment, PwC projects the sector to see deal values ranging from $225 billion to $275 billion. Deal volume in 2023 was in line with pre-pandemic levels. …

Merck, Amgen back Culmination Bio’s quest to transform healthcare data analytics

In the same week that Merck and Amgen revealed expanded alliances with AWS, the bioinformatics startup Culmination Bio revealed that it has received $10 million in funding from the venture arms of those companies, Merck Global Health Innovation Fund and Amgen Ventures. Culmination Bio, a spinoff from Intermountain Health, has developed a vast data lake of de-identified patient records spanning over 40 years.

Dr. Lincoln Nadauld, CEO of the startup, notes that the funding is evidence that the data it has collected can address pharma’s longstanding quest to boost the efficiency of drug discovery and development. Frequently, pharma companies have “access to vast datasets, but those datasets are often not the right kind of data,” Nadauld said. “It’s fragmented, or it’s unstructured, or it’s deficient in some fashion.”

Culmination Bio readies data lake based on four decades of patient health records

Consequently, Culmination Bio is confident that t…

AWS expands collaborations with Amgen and Merck to advance AI in drug discovery and manufacturing

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At its annual re:Invent event, Amazon Web Services (AWS) announced expanded alliances with two leading drug developers, Amgen and Merck, to create generative artificial intelligence (AI) technologies aimed at accelerating drug discovery and increasing efficiencies in manufacturing processes.

Merck has been working with AWS and Accenture for several years whereas Amgen and AWS have collaborated for more than a decade.

Reflecting on AWS’s presence in the life sciences, Dan Sheeran, general manager of healthcare and life sciences at AWS, noted the company works with thousands of global healthcare and life sciences customers, including nine of the top 10 pharma companies.

“Healthcare and life sciences organizations are increasingly turning to AWS and technology as a business differentiator—especially with the explosion of generative AI,” Sheeran said. “Our pharma c…

Sandoz’s Hyrimoz to challenge AbbVie’s Humira dominance

A robotic arm transfers Humira pens from the conveyor to two-pack cartons. [Image from AbbVie]

The generic and biosimilar company Sandoz, a Novartis (NYSE:SIX) subsidiary, has received FDA approval for its Humira biosimilar Hyrimoz (adalimumab-adaz) injection. AbbVie’s (NYSE:ABBV) megablockbuster Humira is a biologic medication with indications for an array of autoimmune conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Sandoz’s biosimilar will likely be priced significantly lower than Humira’s. This fact could dramatically impact the marketplace for AbbVie’s version of the drug, as it is priced lower and could lead to a decrease in market share for Humira.

The FDA approved Sandoz’s Hyrimoz, a biosimilar of AbbVie’s Humira, to treat seven conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis,…

Prominent pharma M&A deals to watch in Q1 2023: Pfizer, Sanofi and others on the hunt

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After a relatively quiet 2022, 2023 is anticipated to be a more robust year for pharma M&A activity. In recent months, players such as Pfizer (NYSE:PFE), Sanofi (NYSE:SNY), Chiesi, AstraZeneca (LON:AZN) and Amgen (Nasdaq:AMGN) have unveiled acquisition plans that could reshape the landscape of the sector. This article delves into the details of prominent recent M&A deals and explores their potential impact on the future of the pharma sector.

Pfizer plans to acquire Seagen

New York City–based Pfizer has recently been on a shopping spree, scooping up Trillium Therapeutics, Biohaven, Global Blood Therapeutics, and Arena Pharmaceuticals. Now, the company has unveiled its plans to acquire Seagen (Nasdaq:SGEN), a Seattle biotech firm focused on oncology. The proposed acquisition, valued at $43 billion, awaits regulatory approval. Pfizer plans to offer $229 per share…

100 top cell and gene therapy companies to watch in 2023

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The cell and gene therapy sector is poised to deliver a wave of new therapies that could potentially cure rare and common diseases. As many as 13 new cell or gene therapies could be approved for use in the U.S., Europe, or both by the end of 2023.

While manufacturing and regulatory challenges remain, the cell and gene therapy industry continues to offer significant therapeutic potential and commercial opportunities.

This year, we have beefed up our list of leading cell and gene therapy companies, doubling the number of organizations from 50 to 100.

In selecting the companies for this list, we weighed public companies’ degree of involvement in cell and gene therapy, including drug developers, equipment vendors and CDMOs specializing in the area. For private companies, we factored in their funding levels, pipeline and degree of history for the list.

B…

Pharma layoffs in 2023: Companies making cuts

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A recession in 2023 is highly probable. Some two-thirds of economists surveyed at the World Economic Forum in Davos said they anticipated an economic downturn this year.

Given the difficult economic situation, a growing number of pharmaceutical firms are reducing staff. Several companies announced cuts at the end of 2022, including Catalent and Novartis.

The following is a list of some significant pharma layoffs announced at the outset of 2023.

Amgen cuts 300 workers

The company is undergoing a restructuring effort that includes layoffs of around 300 employees. The pharma layoffs will primarily affect employees in the commercial team based in the U.S., according to a report obtained from Endpoints.

Merck KGaA lays off 133

Merck KGaA, Darmstadt, Germany, is letting go of 133 jobs in Billerica, Massachusetts, as part of a restructuring effort, according t…

4 top drug discovery innovations of 2022

Prix Galien

Late last year, the Galien Foundation highlighted several drug discovery innovations in its annual Prix Galien USA Award Winners, which specifically highlighted drugs from Regeneron and Amgen as well as a platform from Exscientia and the incubators BioLabs and LabCentral.

The foundation recently hosted a webinar featuring several executives from the respective winning companies discussing their view on their respective drug discovery innovations.

1. Inmazeb: The first FDA-approved Ebola drug

The Galien Foundation chose Regeneron’s (Nasdaq:REGN) Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the best biotechnology product of 2022. The antibody cocktail became the first FDA-approved treatment for Ebola (Zaire Ebolavirus) for pediatric and adult patients in 2020.

There were several hurdles involved in developing Inmazeb, said Neil Stahl, EVP of R&D at Regeneron Phar…

And the most innovative biotechnology and pharma products are…

The Galien Foundation has selected Regeneron’s (Nasdaq:REGN) Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) as the best biotechnology product of 2022 and Amgen’s (Nasdaq:AMGN) Lumakras as the best pharmaceutical agent.

The organization announced the news last week as part of the Prix Galien USA 2022 awards series.

The antibody cocktail Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) became the first FDA-approved treatment for Ebola (Zaire Ebolavirus) for pediatric and adult patients in 2020.

The Tarrytown, New York–based biotechnology company Regeneron developed Inmazeb with its proprietary VelocImmune mouse technology to facilitate the immediate generation of genetically altered mice from modified embryonic stem cells. In addition, the technique enabled the company to study the drug preclinically without breeding multiple generations of mice.

“Our groundbreaking ‘rapid response’ application of our Veloci…