Quality Systems

EMA has halted the rolling review of CureVac's COVID-19 candidate, CVnCoV, due to the company withdrawing from the process.

MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.

The approval of ChemoCentryx’s Tavenos (avacopan) provides a new treatment for active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.

AstraZeneca’s tezelpelumab was granted orphan drug designation by FDA for the treatment of eosinophilic esophagitis.

FDA’s emergency use authorization will double rapid at-home COVID-19 testing capacity.

The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.

Vaccine access campaigners have projected a request to waive vaccine patents onto the hotel where the annual conservative party conference is being held.

Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.

Almost half of pharmaceutical industry profits continue to come from biopharmaceuticals.

Updates to Ph. Eur. include validated tests for N-nitrosamine impurities in sartan APIs.

Public health challenges have highlighted the need for agility in maintaining the quality of medicines.

A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.

Appili Therapeutics and AiPharma Global Holdings announced a strategic alliance to advance the global development of a broad-spectrum antiviral treatment in oral tablet form for the treatment of COVID-19.

FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.

EMA's CHMP is going to perform an accelerated assessment of data submitted by Moderna regarding the use of a booster dose of Spikevax.

EMA is providing support via its Innovation Task Force (ITF) for developers to help them reduce, replace, and refine animal use in drug development.

FDA granted orphan drug designation to Catalyst Biosciences’ MarzAA for the treatment of Factor VII Deficiency.

FDA approved AbbVie’s Qulipta (atogepant) as a preventative migraine treatment.

GeneTx Biotherapeutics and Ultragenyx Pharmaceutical announced that FDA has removed the clinical hold on GTX-102, an investigational treatment for Angelman syndrome.

The lack of a new permanent commissioner has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints.

Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.

GSK has received a positive recommendation from the EMA’s CHMP for Nucala (mepolizumab) to be used as a treatment in three additional eosinophil-driven diseases.

Celltrion Group has been granted approval for regdanvimab (CT-P59) to be used as a treatment for COVID-19 by the Korean Ministry of Food and Drug Safety (MFDS).