List view / Grid view
The submission is the first in a series that will include dengue-endemic countries, it includes long-term Phase III safety and efficacy data for the TAK-003 vaccine candidate.
The warning letters were issued to two companies illegally selling over-the-counter cannabidiol (CBD) products for pain relief.
The recommendation will allow more data to be collected about the combination treatment while allowing patients with high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer to access the medication.
This whitepaper considers the latest EU GMP Annex 1 draft and its impact on the control and release of sterile products.
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies.
AstraZeneca’s Calquence (acalabrutinib), a chemotherapy-free monotherapy, will be offered to patients with chronic lymphocytic leukaemia.
The EMA’s drug safety committee concluded that the vaccine is not associated with an increased risk of thromboembolic events and that its benefits still outweigh its risks.
European Pharmaceutical Review’s Hannah Balfour outlines the findings of market research reports exploring the challenges and drivers for the pharmaceutical packaging equipment market between 2020 and 2025.
The Federal Trade Commission will work with international regulators to review the effects of pharma mergers and update approaches to analysing them.
Having received the CE certificate, Fujifilm can now launch its highly-sensitive, rapid antigen test kit for SARS-CoV-2 in Europe.
In this article, Dr Ronan Brown, IQVIA’s SVP and Head of Integrated Global Compliance, explores the long-term impact of COVID-19 on regulatory practices in three key areas: clinical trial study design, clinical trial study development and post-clinical trial regulatory submissions.
The Janssen COVID-19 Vaccine is the first single-dose vaccine regimen to ever be granted WHO emergency use listing and is now eligible for distribution via COVAX.
After a positive recommendation from the EMA, the European Commission has granted the single-dose vaccine conditional marketing authorisation.
In the wake of the UK’s agreed deal with the EU, Andrew Howard, Deputy Director for Trade, Regulation and Analysis in the Office for Life Sciences, offers advice to those life sciences businesses navigating the transition to a new regulatory landscape.
In a high-risk patient cohort, treatment with the combination of bamlanivimab and etesevimab reduces COVID-19 related hospitalisation and death by 87 percent.
