Small biopharma companies often need to partner with larger firms to achieve their goals, but such agreements can fail if preparations are poor. Here, Diane Seimetz and Jörg Schneider at Biopharma Excellence discuss how due diligence smooths the path to collaboration.
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The European Medicines Agency (EMA)
Setting a new standard of care for liver MRI contrast agents in patients with reduced kidney function
A ‘hot’ topic on the radar of radiologists in recent years has been the safety of the potentially toxic gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI). This is especially pertinent in the detection of focal liver lesions for patients with poor kidney function due to potentially fatal…
EMA’s pharmacovigilance committee recommends product information updates for two COVID-19 vaccines - Janssen COVID-19 Vaccine and Moderna’s Spikevax.
The report outlines the positive impact the EMA’s PRIority Medicines (PRIME) scheme has had on drug development for unmet medical need over the last five years.
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
Here, Frits Stulp and Duncan van Rijsbergen of Iperion explore how startups can establish the most efficient data management processes and systems, avoiding the kind of mistakes made by Big Pharma.
The Common Standard for electronic product information (ePI) is intended to improve delivery of information to patients and healthcare providers.
EMA will establish the DARWIN EU® Coordination Centre to develop and manage a network of real-world healthcare data sources across the EU.
In this article, Sarah Bly and Aman Khera of Worldwide Clinical Trials break down the seven key differences between the EU Clinical Trial Directive and new EU Clinical Trial Regulation, discussing when and how sponsors should begin submitting their trials through the new CTIS portal system.
Regulators encourage the development of bivalent or multivalent variant COVID-19 vaccines to continue to combat the disease and its variants.
A review of studies involving 65,000 pregnancies suggests mRNA COVID-19 vaccines do not increase the risk of pregnancy complications.
The EMA’s pharmacovigilance committee (PRAC) began reviewing terlipressin containing medicines and recommended updates to COVID-19 vaccine safety information.
The new ACT EU initiative seeks to transform how clinical trials are initiated, designed and run in the European Union.
A team of American scientists report on some recent developments in the realm of pharmaceutical stress testing, or forced degradation, practices relating to solid dosage forms, bringing some valuable clarity for drug developers.