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Novelty Nobility Expands AGC Biologics Deal to Take Product Candidate Through GMP Manufacturing
Korea-based Novelty Nobility expanded its agreement with CDMO AGC Biologics to advance their bispecific antibody drug candidate through process development and GMP manufacturing at AGC Biologics’ facility in Chiba, Japan. The project leverages AGC Biologics’ global network, having completed cell line development in Copenhagen, Denmark, to be followed by tech transfer to the Chiba site for the next manufacturing stages.
“We believe this bispecific antibody has the potential to offer a truly differentiated treatment option for patients with neovascular retinal diseases,” said Sang Gyu Park, CEO of Novelty Nobility.
The product candidate, NN4101, a first-in-class, connects a fully human anti-c-Kit monoclonal antibody with a vascular endothelial growth factor (VEGF) trap.
“Our mammalian expression teams are adept at handling complex proteins, and we are a world leader in applying flexible, single-use bioreactor technology,” commented said Tadashi Murano, president of the AGC Life Science Company. “We are proud to support Novelty Nobility as they advance this innovative candidate toward the clinic.”
To further support growing demand in the region and globally, AGC is also expanding its facility in Yokohama, Japan, which is designed to utilize single-use bioreactor technology to offer large-scale GMP manufacturing.
The post Novelty Nobility Expands AGC Biologics Deal to Take Product Candidate Through GMP Manufacturing appeared first on GEN – Genetic Engineering and Biotechnology News.
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STAT+: Novo Nordisk’s less-bad news on its Wegovy pill boosts earnings and share price
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Good morning. We’ve got more earnings today, and my colleague Drew Joseph brings us a dispatch from Rome.
The need-to-know this morning
- German drug maker Bayer said it is acquiring Perfusion Therapeutics, a privately held developer of treatments for eye diseases.
- Vivek Ramaswamy, the biotech executive-turned politician, won the Republican primary for governor of Ohio on Tuesday.
- Madrigal Pharma said sales of its MASH drug Rezdiffra were $311 million in the first quarter, topping Wall Street estimates.
- United Therapeutics also reported earnings.
Novo Nordisk saw its shares rise after being able to report some less-bad news.
The Danish firm, which had been trailing rival Eli Lilly in the obesity drug market, has gained some recent momentum with the hugely successful launch of its Wegovy pill in the U.S. And in releasing first quarter results Wednesday, Novo ticked up its guidance for the year, saying that adjusted sales will drop from 4% to 12% (the company previously said they would be down 5% to 13%), an identical shift also seen in its forecast for adjusted operating profit. The improving outlook is largely driven by better sales performance, Novo said.
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
Good morning. We’ve got more earnings today, and my colleague Drew Joseph brings us a dispatch from Rome.
The need-to-know this morning
- German drug maker Bayer said it is acquiring Perfusion Therapeutics, a privately held developer of treatments for eye diseases.
- Vivek Ramaswamy, the biotech executive-turned politician, won the Republican primary for governor of Ohio on Tuesday.
- Madrigal Pharma said sales of its MASH drug Rezdiffra were $311 million in the first quarter, topping Wall Street estimates.
- United Therapeutics also reported earnings.
Novo Nordisk saw its shares rise after being able to report some less-bad news.
The Danish firm, which had been trailing rival Eli Lilly in the obesity drug market, has gained some recent momentum with the hugely successful launch of its Wegovy pill in the U.S. And in releasing first quarter results Wednesday, Novo ticked up its guidance for the year, saying that adjusted sales will drop from 4% to 12% (the company previously said they would be down 5% to 13%), an identical shift also seen in its forecast for adjusted operating profit. The improving outlook is largely driven by better sales performance, Novo said.
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Bayer ends multi-year M&A drought with up to $2.45B Perfuse buy
Bayer ends multi-year M&A drought with up to $2.45B Perfuse buy
For $300 million upfront, Bayer is purchasing Perfuse Therapeutics to advance an eye implant for glaucoma and diabetic retinopathy, marking the company’s first pharma acquisition since 2021. Read More
Viridian Therapeutics’ elegrobart normalized the degree of eye protrusion and improved double vision in a Phase 3 study. The company plans to file for approval in the first quarter of 2027.
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STAT+: Novo Nordisk’s less-bad news on its Wegovy pill boosts earnings and share price
Bayer ends multi-year M&A drought with up to $2.45B Perfuse buy
Viridian turns green again as new Phase 3 data vindicate thyroid eye disease drug
Novelty Nobility Expands AGC Biologics Deal to Take Product Candidate Through GMP Manufacturing
J&J pushes dual-antibody IBD therapy into Phase 3 despite mid-stage fails
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Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
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