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Pfizer, Lilly, more report Q1, FDA names acting CBER director and an ALS awakening

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First quarter earnings continue to arrive, with analysts demanding more from cautious Pfizer and Eli Lilly expecting more revenue; the FDA taps Katherine Szarama as Vinay Prasad’s controversial FDA tenure ends; oncology veterans miss Richard Pazdur at the agency’s first adcomm in nine months; and QurAlis and Corcept Therapeutics spark renewed hope in ALS.

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Viridian turns green again as new Phase 3 data vindicate thyroid eye disease drug

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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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Novelty Nobility Expands AGC Biologics Deal to Take Product Candidate Through GMP Manufacturing

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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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J&J pushes dual-antibody IBD therapy into Phase 3 despite mid-stage fails

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Johnson & Johnson plans to advance the co-antibody therapy, which combines its IL-23 blocker Tremfya and the TNF-alpha inhibitor Simponi, into late-stage testing for Crohn’s disease and ulcerative colitis.

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