Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
News|Articles|February 12, 2013
Lilly Discontinues Phase III Rheumatoid Arthritis Program
Author(s)Amy Ritter, PhD
Eli Lilly and Co. announced that it will discontinue its Phase III rheumatoid arthritis program for tabalumab, an anti-BAFF (B cell activating factor) monoclonal antibody, because of lack of efficacy.
Advertisement
Eli Lilly and Co.
"While we are obviously disappointed by these results in rheumatoid arthritis, we continue to believe that tabalumab could have significant potential for patients in other disease areas," said Eiry Roberts, M.D., vice-president of autoimmune product development at Lilly in the company press release. "Autoimmune disorders are highly individualized. We believe that targeting BAFF with a molecule such as tabalumab may still represent an important advance for patients, and therefore we will continue the ongoing Phase III tabalumab lupus program."
Advertisement
Related to this article
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Richard Jaenisch examines whether FDA's NAM pathway truly shortens drug pipelines or just shifts the evidentiary burden elsewhere.
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Pritelivir Shifts Resistant Herpes Care from Intravenous to Oral
2
Complying with International Pharmacopoeias
3
Manufacturing Intelligence: Organoids, Organ-on-a-Chip, and the Trust Gap
4
CPHI Milan 2026: Nitrosamine Risk Mitigation, Part 2
5