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|October 29, 2021
Otsuka Applies to EMA for Marketing Authorization of Vadadustat
Author(s)Pharmaceutical Technology Editors
Otsuka has submitted an initial marketing authorization application to EMA for vadadustat as a treatment of anemia associated with CKD in adults.
Advertisement
Otsuka Pharmaceutical Europe has announced, in an Oct. 29, 2021 press release, that Otsuka Pharmaceutical Netherlands has submitted an initial marketing authorization application to the European Medicines Agency (EMA) for vadadustat.
Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor aimed at the treatment of anemia associated with chronic kidney disease (CKD) in adults. The therapy was developed under a collaboration and license agreement with Akebia Therapeutics.
“We are excited to reach this regulatory milestone in collaboration with Akebia, demonstrating our continued commitment to patients with chronic kidney disease” said Andy Hodge, CEO of Otsuka Pharmaceutical Europe Ltd. and Otsuka Pharmaceutical Development and Commercialization Europe GmbH, in the press release.
Source:
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.
At PDA/FDA Joint Regulatory Conference 2026, PCI Pharma's Bassler details how a QMS overhaul turned an FDA 483 into stronger quality culture.
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.
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