PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
News|Articles|August 4, 2016
Ribociclib Receives Breakthrough Therapy Designation
Author(s)Pharmaceutical Technology Editors
The cyclin dependent kinase inhibitor received Breakthrough Therapy Designation as a first line treatment for advanced breast cancer.
Advertisement
Novartis’ cyclin dependent kinase (CDK4/6) inhibitor LEE011 (ribociclib) in combination with letrozole, received Breakthrough Therapy Designation from FDA as a first line treatment for hormone receptor positive, human epidermal growth factor receptor 2-negative advanced breast cancer (HR+/HER2-), the company said in an August 3, 2016 press announcement. This marks the company’s 11th Breakthrough Therapy Designation from FDA.
The Breakthrough Therapy designation is primarily based on results from a Phase III MONALEESA-2 trial in combination with letrozole. According to Novartis, Phase III trials met the primary endpoint for clinically meaningful improvement in progression free survival. If approved, the drug may be a direct competitor with Pfizer’s Ibrance (palbociclib), an oral inhibitor of cyclin-dependent kinases 4 and 6. In a Q2 earnings report, Pfizer noted Ibrance continued to perform strongly for the company.
Advertisement
Related to this article
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
Karthik Iyer, Eli Lilly, details an AI system linking GMP findings, audits, and deviations for cited, inspection-ready regulatory intelligence.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.
AI can turn medical device risk management into a continuous signal.
On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.
This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.
The EU is focused on strengthening supply-chain resilience, avoiding medicine shortages, simplifying regulations, and implementing new approach methodologies.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Driving Quality Culture to Manage Risk: Lessons from an FDA Inspection Response
2
FDA's IND Pilot Puts CMC Review First
3
Mature Medicines Divestment Signals Shift in Manufacturing Strategy
4
Successful Internal Audit Planning and Execution
5