Within clinical trial translations, informed patient consent forms (ICFs) are an important and mandatory prerequisite for all submissions that not only represent the patient’s individual rights but also serve as an underlying principle of medical ethics. Under the...
The European Commission (EC) has granted orphan-drug designation (ODD) for Astex Pharma’s oral fixed dose ASTX727 to treat Acute Myeloid Leukemia (AML). AML, a blood cancer characterized by the overproduction of immature white blood cells within the bone marrow, is...
While Eli Lilly has withdrawn its request for European Union (EU) approval of its COVID-19 antibody-based treatment as the EU pivots its focus on other suppliers, the US has agreed to buy 614,000 additional doses of Lilly’s antibody combo for $1.29 billion. The...
The European Commission announced that 70% of adults in the European Union (EU) are fully vaccinated against COVID-19, meeting the target that was initially set in January 2021, at the start of the vaccine rollout. This milestone marks a success for the EU’s...
The European Medicines Agency (EMA) has added another blood condition side effect to the growing list for AstraZeneca’s COVID-19 vaccine. The rare blood condition known as capillary leak syndrome causes blood to spill from blood vessels to nearby muscles and...
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