If the maximum fair prices (MFPs) the U.S. CMS announced after the first round of drug price negotiations are any indication, advocates of the government price setting may be settling for short-term wins at the cost of long-term, more sustainable price reductions driven by competition. The MFPs set for the 10 Part D drugs selected for negotiations delivered an overall average price reduction of 46%. In contrast, biosimilar competition over the past nine years has resulted in an overall average price reduction of 58%, according to statistics provided by Samsung Bioepis Co. Ltd.

Tyra shares sink on FGFR3 phase I/II data in urothelial cancer

Tyra Biosciences Inc. unveiled what the company described as “encouraging” proof-of-concept data with TYRA-300 in patients with metastatic urothelial cancer from the ongoing Surf301 phase I/II study. The findings from Tyra were offered at the ORTC-NCI-AACR symposium on molecular targets and cancer therapeutics in Barcelona. TYRA-300 is a potential first-in-class, investigational, oral, FGFR3-selective inhibitor designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while working in a way agnostic for FGFR3 gatekeeper mutations. Shares (NASDAQ:TYRA) were trading at $23.48, down $5.14, or almost 18%.

Otsuka says IgAN, too, with phase III sibeprenlimab data

Visterra Inc., a subsidiary of Otsuka Pharmaceutical Co. Ltd., reported positive top-line data from the ongoing Visionary phase III study of sibeprenlimab, an anti-APRIL monoclonal antibody for immunoglobulin A nephropathy (IgAN). According to Otsuka, sibeprenlimab met the primary endpoint of reducing 24-hour protein-to-creatine ratio (uPCR) in IgAN patients when compared to placebo after nine months of treatment. While details of the prespecified interim analysis were not disclosed, sibeprenlimab’s improvements in uPCR were “statistically significant” and “clinically meaningful” over placebo, Otsuka said.

September conferences deliver a wave of positive clinical trial updates

In September 2024, BioWorld recorded 252 clinical trial updates, up from 92 in August, with the rise due in part to news from the European Society for Cardiology Congress, the IASCLC World Conference on Lung Cancer and the European Association for the Study of Diabetes, among others. The month included 35 successful phase III trial updates and four failures.

Using black hole study methods, digital twins take aim at the patient black box

Currently, cancer therapy trial-and-error methodology is inefficient and unsustainable. Oncology is the worst therapeutic area for drug trial success; only 3.4% of drugs that enter phase I end up being FDA approved, and 57% fail due to poor drug efficacy in trials. Building tools that may aid in predicting an individual’s response to a specific therapy may help in reducing costs, guesswork, and importantly improve the outcome of patients and accelerate new drug development.

The BioWorld Insider podcast: A quantum leap into the future of drug development

In the newest BioWorld Insider podcast, Victoria Lipinska, the America's lead for Quantum Innovation Centers at IBM Quantum, talks about the future of drug development using quantum computing. “The new technology is a completely different branch of computing as opposed to what we know right now, and it's meant to complement what we know, not to really replace it,” she said. Quantum computing could lead to more efficient drug discovery by identifying promising compounds faster, understanding their effects at the molecular level, and then reducing the need for costly or time-consuming lab experiments. Lipinska is one of the more than 100 experts who will evaluate the future of health care at the upcoming 2024 Biofuture conference. Each year, a group of trailblazers, disruptors and forward-thinking executives converge to evaluate and forecast the future of health care. This year, BioWorld is a sponsor of the Oct. 28-30 event in New York. If you attend, you'll have the chance to hear panels and join workshops and fireside chats with key opinion leaders like Lipinska.

Also in the news

Accent, Alexion, Apogee, Arcus, Astrazeneca, Axovia, Bayer, Biovie, Bridgebio, Dewpoint, Epitopea, GSK, Hibercell, Hope Medicine, Intellia, J Ints, Kisoji, March, Marinus, Medivir, Merck, Monopar, Neurosense, Omeros, Pfizer, Precision, Regeneron, Rhythm, Sanofi, Starget, Telix, UP Oncolytics, Zai Lab