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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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Opinion: Dr. Glaucomflecken wants to make a stink

His real name is Will Flanary, but you probably know him as Dr. Glaucomflecken — the internet’s go-to doctor/comedian. On this episode of the “First Opinion Podcast,” we talked about how he mixes humor with some of the most pressing issues facing health care, from misinformation on social media to the corporate takeover of medicine.

In particular, Flanary has been deeply involved with advocacy around PeaceHealth’s decision to use a corporate group to staff the emergency department in Eugene, Oregon, instead of the community-based physicians who had been there for more than 35 years.

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STAT+: Even at a meeting in Rome, FDA shifts are top of mind for gene therapy field

ROME — When Tim Hunt, who leads an organization for cell and gene therapy makers, reached for some reasons for optimism for the jittery field at a conference here last week, he highlighted the recent approvals of rare disease treatments from the likes of Rocket Pharmaceuticals and Regeneron Pharmaceuticals.

There was one other headline he touted as potentially promising: “FDA vaccine chief to leave the agency again.”

The allusion to Vinay Prasad — the Food and Drug Administration’s top regulator of gene and cell therapies as well as vaccines until his departure from the agency last week — was an indication that even at this event, designed to emphasize the opportunities and roadblocks the sector faces in Europe, it couldn’t escape the decisions that are coming from 4,500 miles away.

Continue to STAT+ to read the full story…

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STAT+: OpenAI wants to ‘have their cake and eat it too’ with health AI policy recommendations

So far, artificial intelligence company OpenAI’s work in health care has been largely limited to nonregulated areas. In January, the company released ChatGPT Health for consumers. Then, it launched ChatGPT for Healthcare for hospitals, followed by ChatGPT for Clinicians. 

Along with the launch of its chatbot for clinicians last month, OpenAI also published a wish list that the company described as a blueprint for unlocking AI’s potential to change the broader health care system. The policy proposals outlined in the document, experts told STAT, are somewhat reasonable, but they also disproportionately benefit the company. 

“They’re trying to have their cake and eat it too,” said David Blumenthal, a former national coordinator for health IT and a health policy professor at Harvard University. “They’re trying to potentially sound like responsible parties in the current conversation while at the same time wanting the markets to stay open for their products.”

Continue to STAT+ to read the full story…

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Opinion: Trump’s executive order on psychedelics is the right move. But is my field ready for it?

I have spent the last 10 years of my life investigating psychedelics as novel treatments for mental health conditions. When President Trump signed his executive order on psychedelic medicines, my first thought was: He got this one right. My second thought: My field may not be ready for it.

The order itself is sweeping. It directs the Food and Drug Administration to issue priority review vouchers to accelerate approval timelines, expands right-to-try pathways for ibogaine, dedicates $50 million in ARPA-H funding to psychedelic research, authorizes the Drug Enforcement Administration to speed scheduling of FDA-approved psychedelics, and launches collaboration with Veterans Affairs on therapies for veterans.

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Biomarkers of ASD/ADHD and Factors Affecting Anxiety and Depression in Children and Young Adults

Conditions: ADHD – Attention Deficit Disorder With Hyperactivity; Autism Spectrum Disorder (ASD); Developmental Coordination Disorder (DCD)

Sponsors: University of Exeter; University of Southampton; University of Dublin, Trinity College; Carol Davila University of Medicine and Pharmacy; Jimma University; FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS; The International Centre for Diarrhoeal Disease Research, Bangladesh; University of Bari Aldo Moro

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Pilot of Unstuck and On Target in Ecuador

Conditions: Autism Spectrum Disorder; Attention Deficit Disorder With Hyperactivity (ADHD)

Interventions: Behavioral: Spanish-Language Unstuck and On Target (SL-Unstuck)

Sponsors: University of Colorado, Denver; Neurodesarrollo Quito

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