The European Medicines Agency Review of Kymriah (Tisagenlecleucel) for the Treatment of Acute Lymphoblastic Leukemia and Diffuse Large B-Cell Lymphoma.

Chimeric antigen receptor (CAR)-engineered T-cell therapy is becoming one of the most promising approaches in the treatment of cancer. On June 28, 2018, the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kymriah for pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse after transplant, or in second or later relapse and for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Kymriah became one of the first European Union-approved CAR T therapies.

Risk of fetal death after pandemic influenza virus infection or vaccination.

Background: During the 2009 influenza A (H1N1) pandemic, pregnant women were at risk for severe influenza illness. This concern was complicated by questions about vaccine safety in pregnant women that were raised by anecdotal reports of fetal deaths after vaccination.

Methods: We explored the safety of influenza vaccination of pregnant women by linking Norwegian national registries and medical consultation data to determine influenza diagnosis, vaccination status, birth outcomes, and background information for pregnant women before, during, and after the pandemic.

[Adverse events related to substitution of generic products in Norway 2005].

Background: The Norwegian Medicines Agency has since 2003 encouraged health professionals to report adverse events (AEs) related to generic substitution through the spontaneous reporting system. Goals of this study were to evaluate the quality of these reported AEs and to assess whether there were signals of altered efficacy or AEs related to substitution of such products.

Material And Methods: The World Health Organisation's (WHO) tool for documentation grading was used to evaluate the AE reports.

[Can the screening of blood samples identify adverse drug reactions?].

Background: Analysis of blood samples may identify adverse drug reactions (ADRs) and risk situations. The study objective was to validate a method for in-hospital detection of ADRs based on screening of blood samples.

Material And Methods: Routine blood samples from patients in a geriatric ward were screened according to simple decision criteria to identify ADRs.