At PDA/FDA Joint Regulatory Conference 2026, PCI Pharma's Bassler details how a QMS overhaul turned an FDA 483 into stronger quality culture.
News|Articles|April 2, 2020
MAA for Diurnal’s Chronocort Passes EMA Validation Stage
Author(s)Pharmaceutical Technology Editors
Specialty pharmaceutical company, Diurnal, has announced that the marketing authorization application (MAA) for Chronocort has passed validation with the European Medicines Agency (EMA).
Advertisement
Specialty pharmaceutical company, Diurnal, has announced, in an April 1, 2020 press release, that the marketing authorization application (MAA) for Chronocort has passed validation with the European Medicines Agency (EMA).
Chronocort is a modified release preparation of hydrocortisone that has been designed to treat a rare condition, congenital adrenal hyperplasia (CAH). The MAA for Chronocort was originally submitted in December 2019.
“We are pleased to announce that our MAA for Chronocort has been validated and we look forward to working with the EMA during the review process,” said Martin Whitaker, CEO of Diurnal, in the press release. “This is another important step towards the targeted recommendation for approval of our second product in Q1 2021. There is a significant need for new therapies to improve outcomes for adult and adolescent patients with CAH, which still results in increased morbidity and mortality. Following the recent [United States] licensing agreement with Eton Pharmaceuticals for Alkindi Sprinkle and £11.2 million (US$13.8 million) placing, Diurnal now has a strong cash position to progress through to and past the anticipated approval date for Chronocort.”
Source:
Advertisement
Related to this article
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
Florin Muraru, Gourav Pandey, and Richard Jaenisch explain where human sign-off belongs as multi-agent AI and document-parsing models reach GxP.
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.
The EC has approved AstraZeneca's Trixeo Aerosphere as the first single-inhaler triple-combination therapy for asthma in the EU, based on phase e data showing improved lung function and fewer severe exacerbations in patients uncontrolled on standard ICS/LABA treatment.
In this episode of Pharma Fundamentals, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development.
Swedish biotech companies have a broad and varied product pipeline that is attracting attention from venture capitalists and pharmaceutical companies.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
The FDA Finalizes Rule Recognizing Non-Animal Testing Methods, Building on Year-Long Reduction Push
2
EU Clears AstraZeneca's Trixeo for Asthma, Opening New Manufacturing Demand for Single-Inhaler Triple Therapy
3
PharmTech AI Pulse Check: Fixing AI Slop at the Source
4
Sweden, a Powerhouse for Early Stage Innovation
5