Amgen Archives - Medical Design Sourcing

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…

Amgen to pay almost $4B for ChemoCentryx

Amgen (Nasdaq:AMGN) announced that it would purchase the San Carlos, California–based ChemoCentryx (Nasdaq:CCXI) for $52 per share in cash, which equates to a total of approximately $3.7 billion.

The centerpiece of the proposed acquisition is Tavneos (avacopan), which scored FDA approval last year for the adjunctive treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The disease is associated with inflammation and damage to small blood vessels. Approximately 10,000 people in the U.S.are diagnosed with the condition annually.

U.S. sales of the drug in the first quarter of 2022 were $5.4 million.

Tavneos is an oral selective complement component 5a receptor inhibitor.

ChemoCentryx also has three early-stage drug candidates targeting chemoattractant receptors in other inflammatory diseases and an oral checkpoint inhibitor.

After announcing the plan, CCXI shares surged 109% to $50.38 in mid-day trading. AMGN shares h…

Amgen exec describes generative biology’s promise to unveil sequence, structure and function

Amgen (Nasdaq:AMGN) is sharpening its focus on generative biology, an emerging discipline that can accelerate protein drug discovery.

The company describes generative biology as “a revolutionary approach to drug discovery and development” that enlists the help of AI and machine learning to design novel protein therapeutics.

Although the term generative biology may be new, Amgen has invested in the marriage of wet lab high throughput automation and dry lab computational biology for decades.

A recently created internal team known as the Digital Biologics Discovery Group aims to expand its focus on generative biology. Leading that group is Alan Russell, who is currently Amgen’s vice president of biologics. Before joining the company, Russell founded and led the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. He also created and led the Disruptive Health Technology Institute at Carnegie Mellon University.

J&J and Roche named to Clarivate’s Top 100 Global Innovators list

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

Gilead Sciences, Merck near the top of Newsweek’s most responsible companies list

A handful of big names in drug discovery and development are among the 500 “most responsible,” according to Newsweek.

The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with an overall score out of 100 that combined assessments on environmental, social and corporate governance performance.

Gilead Sciences (NSDQ:GILD), Merck (NYSE:MRK) and Pfizer (NYSE:PFE) were among the pharmaceutical companies to land a spot in the top-500, with a number of other drug development, pharmaceutical processing and manufacturing companies included.

The highest-ranking company was Gilead in sixth, landing an overall score of 89.9 points (90.6 environmental, 81.1 social and 98.2 corporate governance).

Merck was next-best in ninth at 89.3 points (94.6, 81.4, 92.…

Medtech M&A: The industry’s biggest mergers and acquisitions of 2021

[Image from Jp Valery on Unsplash]

Across 2021, medtech has seen a wide range of mergers and acquisitions covering several areas of devices, pharmaceuticals and more.

Some have gone off without a hitch, while others fell into serious scrutiny as mouthwatering financial figures were revealed and major technologies were acquired.

Here are the 10 biggest mergers and acquisitions in medtech in 2021:

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Amgen finalizes Teneobio acquisition

Amgen (NSDQ:AMGN) has acquired privately-held immunotherapy specialist Teneobio (Newark, California).

The transaction includes an upfront $900 million upfront payment and future contingent milestone payments worth up to an additional $1.6 billion.

Tenebio’s stated mission was to tap human heavy-chain antibodies to “redirect the immune system to safely fight disease.”

Earlier this year, it had three drug candidates—TNB-383B, TNB-486 and TNB-58—in Phase 1 trials. The company had 11 additional candidates in earlier stages of discovery and development.

Amgen believes that the acquisition will complement its work on T-cell engagers and bi- and multispecific biologics. “Teneobio’s expertise and technologies will further expand our repertoire of multispecific architectures and advance our overarching mission to develop transformative innovation to bring to market best-in-class products to serve our patients,” said Dr. …