Genentech’s crenezumab stumbles in Alzheimer’s trial

Roche (SIX:RO, ROG; OTCQX:RHHBY) subsidiary Genentech announced that a study of the amyloid beta-protein inhibitor crenezumab failed to show statistically significant clinical benefit in Alzheimer’s patients.

The failure is typical. Historically, 99% of Alzheimer’s drug candidate studies fail to show improvement over placebo, according to Alzheimer’s Research & Therapy.

In the research, Genentech partnered with the Banner Alzheimer’s Institute, the University of Antioquia in Colombia and the National Institute on Aging.

The research did find slight differences favoring crenezumab across several endpoints, but they failed to reach statistical significance.

“We’re disappointed that the treatment did not demonstrate a statistically significant clinical benefit,” said Dr. Eric M. Reiman, Banner Alzheimer’s Institute executive director, in a news release. “At the same time, we’re proud of …

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Purdue University launches institute for advanced manufacturing of pharmaceuticals

Thanks to a donation from pharma industry veteran William D. Young, Purdue University has announced plans to launch a new institute dedicated to furthering pharmaceutical manufacturing to reduce costs and bolster access to new biotech drugs.

The William D. Young Institute for Advanced Manufacturing of Pharmaceuticals is named after the eponymous chemical engineer, who graduated from Purdue in 1966. Yong went on to become the chief operating officer of Genentech from 1980 to 1999. Young is now a senior advisor to Blackstone Life Sciences (South San Francisco and Cambridge, Massachusetts).

“We’re honored to receive this gift from a man with a global reputation as a talented chemical engineer who built an outstanding technical and management record in pharmaceutical and biotech manufacturing,” said Purdue President Mitch Daniels in a statement. “Everyone in pharma knows that having Bill Young’s name on the sign means we will be working to the highest standards and…

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Flywheel working with Roche and Genentech to sift through medical imaging data

The research data platform Flywheel has announced that Roche (OTCMKTS:RHHBY) and its subsidiary Genentech are using its cloud-scale informatics platform to ingest, standardize and analyze medical imaging data to streamline drug discovery.

Minneapolis-based Flywheel says the process provides a swifter and more efficient means to curate data at the terabyte and petabyte scales. Specifically, Roche and Genentech are using the platform to assist in finding answers to core scientific questions related to patient care and outcomes.

“With our platform in place, Roche and Genentech researchers can access high-quality images for complex analysis and machine learning, ultimately speeding the development of innovative therapies,” said Jim Olson, CEO of Flywheel, in a press release. “Before using the platform, this level of collaboration and analysis was simply not possible.”

A number of prominent research institutions, including Stanford University, Columbia Univer…

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FDA approves Genentech’s Susvimo drug-eluting eye implant

Genentech’s Susvimo implant. [Image from Genentech]Genentech announced today that it received FDA approval for its Susvimo injection for treating macular degeneration (AMD).

South San Francisco-based Genentech, a member of the Roche Group, designed its Susvimo ranibizumab injection (100 mg/mL) for intravitreal use via ocular implant for treating people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.

Get the full story at our sister site, Drug Delivery Business News.

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An inside look at Northern California’s growing biomanufacturing hub 

Vacaville shown on Google Maps

Vacaville, Calif. is home to a burgeoning biotech hub.

And there’s more to Vacaville’s biomanufacturing industry than Genentech’s presence there. “Genentech is just one of the biotech companies to open in Vacaville,” said Don Burrus, the city’s director of economic development services. “We’ve had biomanufacturers here for almost 30 years.”

Genentech set up shop in the city, located 35 miles southeast of Sacramento, in the late 1990s. The company acquired land in the city in 1994.

More recently, Lexington, Mass.–based Agenus purchased 120 acres in the city.

When Burrus began working for the city in June 2020, he collaborated with economists and other economic development experts to analyze the city’s economic drivers.

“We were able to determine that biomanufacturing and advanced manufacturing were big economic drivers,” Burrus said.

Afte…

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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…

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Biotech Agenus acquires 120 acres in biomanufacturing center in California

Agenus (Lexington, Mass.) has purchased 120 acres in the California Biomanufacturing Center located in Vacaville near Sacramento.

Agenus specializes in immuno-oncology products, which span checkpoint antibodies, cell therapies, vaccines and adjuvants.

Agenus purchased the parcels from A.G. Spanos, a housing developer.

Vacaville is aiming to spur the growth of its biotech industry. Currently, the largest biotech hubs in the state are in the San Francisco Bay Area and Southern California.

“We are excited to expand our manufacturing and process research capabilities in Vacaville as we contemplate the commercialization of our exciting pipeline of high-tech cancer treatments,” said Garo Armen, CEO of Agenus, in a statement. “The city of Vacaville is a true partner with their commitment; Vacaville’s close proximity to talent and its high quality of life offerings were amongst the key considerations in our decision.”

Vacaville, a city of approxima…

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Biosimilars adoption growing, but the market remains nascent

Photo by Tara Winstead from Pexels

While biosimilar adoption remains at an early stage in the U.S., biosimilar adoption is ticking up. Biosimilar penetration for Roche’s Avastin (bevacizumab) is especially high at 69%. In addition, biosimilars for Genentech’s Herceptin and Amgen’s Neupogen have also achieved a market penetration of 57% and 62%, respectively, according to IQVIA data based on late June sales data.

One of the chief factors limiting the size of the biosimilars market, however, is the limited number of biosimilars on the market. While the Affordable Care Act included biosimilar provisions, only 33 biosimilars have won FDA approval since 2015. The agency approved ten of those in 2019.

The Biosimilars Council estimates that biosimilars could save the U.S. as much as $130 billion by 2025.

For now, however, overall adoption remains at a nascent stage. “Various factors have likely influe…

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FDA accepts biologics license application for Genentech’s drug-eluting eye implant

Genentech’s PDS implant. [Image from Genentech]Genentech announced that the FDA accepted its Biologics License Application (BLA) for its Port Delivery System (PDS) with ranibizumab.

PDS, a permanent, refillable eye implant standing at the approximate size of a grain of rice offers continuous delivery of a customized formulation of ranibizumab over a period of months with the intention of reducing the treatment burden associated with frequent eye injections.

Get the full story at our sister site, Drug Delivery Business News.

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Genentech wins FDA approval for Xolair prefilled syringe

Genentech announced today that the FDA approved its supplemental biologics license application for the Xolair prefilled syringe.

South San Francisco-based Genentech touts the Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications as the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for treating moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

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6 notable pulmonary fibrosis research efforts 

Image courtesy of Pixabay

Idiopathic pulmonary fibrosis (IPF) is frequently a debilitating disease associated with significant morbidity and mortality. Although a rare disease, its incidence has increased in recent decades, and it leads to more deaths than some cancers. 

The treatment landscape for the condition changed in 2014 when FDA approved the first drugs indicated for IPF, nintedanib from Boehringer Ingelheim and pirfenidone from Roche (OTCMKTS:RHHBY). 

[Related: The pulmonary fibrosis treatment landscape: An expert interview]

Research on pulmonary fibrosis has increased in recent years. 

Here’s a summary of notable IPF research: 

Boehringer Ingelheim has an international study investigating a phosphodiesterase 4b (PDE4b) inhibitor in patients with idiopathic pulmonary fibrosis. Researchers have found that the drug has anti-fibrotic effects in animal models and lung fibrosis …
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FDA approves Genentech’s drug for rare disease affecting optic nerves, spinal cord

The FDA has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a certain antibody — patients who are anti-aquaporin-4 or AQP4 antibody-positive.

NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Enspryng, made by Genentech, is the third approved treatment for the disorder.

In patients with NMOSD, the immune system mistakenly attacks healthy cells and proteins, most often those in the optic nerves and spinal cord. This typically results in attacks of optic neuritis, which causes eye pain and vision loss. Approximately 50% of patients with NMOSD have permanent visual impairment and paralysis caused by NMOSD attacks. Estimates vary, but NMOSD is thought to affect approximately 4,000 to 8,000 Americans.

NMOSD may be associated with antibodies that bind to a protein called aquaporin-4 (AQP4). Binding of the anti-AQP4 antib…

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