Astellas Pharma Archives - Medical Design Sourcing

Major pharma players ST Pharm, Astellas and Celltrion unveil ambitious expansion blueprints

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A handful of pharma companies, including ST Pharm, Astellas Pharma, Avalon Pharma, and Celltrion have recently announced expansion projects.

Major pharma expansion efforts underway in South Korea

South Korean CDMO firm ST Pharm announced a second manufacturing facility in its home country — in Ansan, Gyeonggi Province. The plant is geared toward supporting burgeoning demand for oligonucleotide active pharmaceutical ingredients (APIs). The 1.1 trillion won investment speaks to the company’s dedication to advancing the oligonucleotide API sector. The company has supplied nucleoside-API’s for global pharma customers since the 1980s.

Also in South Korea, Celltrion is setting aside 126 million South Korean won for a new manufacturing plant at its Songdo campus near Seoul. Expected to be operational by 2027, this facility will have an annual production capacity of 8 million vials…

Astellas latest to wage war against the Inflation Reduction Act

In a recent move, Astellas Pharma challenges IRA, a step that sees them join other pharmaceutical heavyweights in a lawsuit against the federal government. The bone of contention is the Inflation Reduction Act (IRA), a law primarily designed to drive down prescription drug prices, a proposition that no Republican supported.

Astellas, along with the other pharma companies, takes issue with the IRA’s plan to let Medicare negotiate prices on their top-selling drugs. They argue this will not only be financially burdensome but also stifle new drug development and breach their constitutional rights.

Constitutional violations: Astellas Pharma challenges IRA

Astellas Pharma, in its public statement last week, outlined three ways in which it believes the new Medicare Drug Price Negotiation Program is in violation of the Constitution. The key concern is that it’s essentially theft or a “taking of property” by forcing companies to offer lower price…

Astellas Pharma’s $1.7B Iveric Bio buy aims to bolster its ophthalmology market position

Astellas Pharma, the second largest Japanese pharma firm after Takeda, plans on scooping up the biopharma Iveric Bio for roughly $1.7 billion. Iveric focuses on discovering and developing novel therapies for retinal diseases, for approximately $1.7 billion.

Astellas believes the acquisition of Iveric Bio will strengthen its standing in the ophthalmology market, by adding the latter’s pipeline products to its portfolio. The companies expect the deal to close in the third quarter of 2023.

Zimura, a potential geographic atrophy breakthrough

The centerpiece of the Astellas-Iveric Bio deal is the drug candidate, Zimura (avacincaptad pegol), which is now in phase 3 clinical trials for geographic atrophy. The condition trails age-related macular degeneration (AMD) as a leading cause of irreversible blindness among the elderly. Geographic atrophy is an advanced form of the disease. No therapies are now approved to treat the condition.

Zimura, inhibitor of …

Astellas to spend $70M on new biotech campus in South San Francisco

Astellas Pharma (TSE: 4503) plans to establish a biotech campus in South San Francisco, California, as the core of its West Coast R&D operations.

Located near Genentech and Verily Life Sciences facilities, the site at 480 Forbes Boulevard will consolidate several Astellas business units and functions currently based throughout the San Francisco Bay Area.

The operations will be housed in a 154,000-ft2 building.

The company plans to spend $70 million to construct the new facility, including lab and co-working space.

Astellas has ramped up its focus on cell and gene therapy following its 2019 acquisition of Audentes Therapeutics for approximately $3 billion. Astellas Pharma is among the largest cell and gene therapy firms in the world.

Astellas already has an East Coast biomedical innovation hub in Boston area.

The company anticipates completing the construction of the new site in the summer of 2023.

FDA places clinical hold on Astellas clinical trial focused on Pompe disease

Astellas Pharma (TSE:4503) has revealed that the FDA has slapped a clinical hold on its Phase 1/2 FORTIS Pompe disease study after observing a serious adverse event (SAE) — peripheral sensory neuropathy — in a trial participant.

Peripheral sensory neuropathy results from damage to nerves outside of the central nervous system. The condition can lead to pain, numbness and weakness.

The FORTIS study had focused on the experimental adeno-associated virus gene replacement therapy AT845 in adults with late-onset Pompe disease.

Pompe disease is a rare genetic disorder associated with the buildup of glycogen in cells. The disease can lead to progressive muscle weakness and reduced life expectancy. Disease progression is associated with the age of onset.

Classic infantile-onset Pompe disease occurs in the first few months of life. Non-classic infantile-onset manifests around 1 year of age while late-onset appears after that — often in adolescence or adulth…

34 of the most innovative pharmaceutical products

Photo by Myriam Zilles on Unsplash

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to make its selections.

The organization will announce final winers in the competition at ceremony in New York City on October 28, 2021.

In terms of pharmaceutical agents, the organization selected the following 34 nominees:

Company Drug name

AbbVie Inc.

Rinvoq (upadacitinib)

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma

Adhansia XR (methylp…

The most innovative pharmaceutical agents of 2020

The Galien Foundation recently announced nominees for most innovative pharmaceutical agents for its 14th Annual Prix Galien USA Awards.

The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical, pharmaceutical drugs and medical technology products that are designed to improve the human condition.

“As we celebrate 50 years of the Prix Galien process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release.

This year, the foundation nominated 26 pharmaceutical agents that have been FDA-approved for the market within the last five years, and show major potential to affect healthcare. The winners will be announced in October this year.

“While scientific discovery and medical in…

The 26 most innovative pharmaceutical agents of 2020

The Galien Foundation recently announced nominees for most innovative pharmaceutical agents for its 14th Annual Prix Galien USA Awards.

The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical, pharmaceutical drugs and medical technology products that are designed to improve the human condition.

“As we celebrate 50 years of the Prix Galien process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release.

This year, the foundation nominated 26 pharmaceutical agents that have been FDA-approved for the market within the last five years, and show major potential to affect healthcare. The winners will be announced in October this year.

“While scientific discovery and medical in…