Insilico Medicine Inc. plans to raise HK$2.27 billion (US$292 million) in its IPO on the Hong Kong Securities Exchange to advance its clinical pipeline and invest further in generative AI and automated laboratories.
Rznomics Inc. continued South Korea’s year-end biotech rally with a ₩46.35 billion (US$31.35 million) IPO Dec. 18. Proceeds will fund Seongnam-si, South Korea-based Rznomic’s pipeline of gene therapies, built on the company’s trans-splicing ribozyme RNA Replacement Enzyme technology platform.
Eli Lilly and Co. took another step toward adding a way for patients to hang onto their weight loss when the firm disclosed positive top-line data from the phase III Attain-Maintain trial with orforglipron, a once-daily oral small molecule GLP-1 receptor agonist. Indianapolis-based Lilly said that at one year orforglipron met the primary and all key secondary endpoints vs. placebo, delivering superior weight maintenance as an adjunct to a healthy diet and physical activity, using the efficacy estimand and modified treatment-regimen estimand.
Advances in antiretroviral therapy (ART) now allow people living with HIV to lead normal lives with undetectable and nontransmissible levels of the virus in their blood. Yet that reality is limited to those with access to treatment. More than 40 million people worldwide live with HIV, with over a million new infections and hundreds of thousands of deaths each year, underscoring that major challenges remain.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Adagene, Aldeyra, Astrazeneca, Chiesi, Daiichi, GSK, Organogenesis, Palvella, Sprout.
Biopharma happenings, including deals and partnerships, and other news in brief: Generation, Imcheck, Ipsen, Maplight, Nuvalent, Royalty, Sandboxaq, Tonix, Xoma.
The U.S. FDA announced Dec. 15 that it will take a more relaxed approach regarding the use of real-world evidence (RWE) in drug and device application reviews. Specifically, new guidance for device premarket applications will not require identifiable individual patient data collected from real-world data sources, and the agency indicated it intends to consider similarly updating guidance regarding submissions for drugs and biologics.