Paul-Ehrlich-Institut

High demand for Beyfortus is expected at the beginning of the RSV season due to the new STIKO recommendation on RSV immunisation. In order to meet this demand, the marketing authorisation holder Sanofi Winthrop Industrie will place packs of the medicine from France and Spain on the German market from 1 September, 2024, to 30 October, 2024. These products are pharmaceutically identical and differ only in the packaging. #Immunisation #RSV #MedicinesSupply 👉 https://lnkd.in/d9aFf89v

🎉 Congratulations to our colleague Thomas Holzhauser, Professor, Ph.D., Deputy Head of the Central Method Development Section at the Paul-Ehrlich-Institut's Allergology Division! The Justus-Liebig-Universität Giessen has awarded him an honorary professorship. His research and teaching activities focus on molecular allergology and allergen analysis of food and medicines. 📅 Save the date: Professor Holzhauser will give his inaugural lecture on 1 November 2024 at 3 pm in Lecture Hall C2 (Heinrich-Buff-Ring 19, Giessen). All interested people are cordially invited.

Information to pharmaceutical companies on the responsibilites for IgG Fc fusion proteins – In order to simplify the situation for pharmaceutical companies and developers, the Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines (PEI), and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)) have agreed to transfer primary responsibilities regarding IgG Fc fusion proteins to the BfArM. 👉 More information: https://lnkd.in/e6dcXgHu

Information to manufacturers of in vitro diagnostic medical devices (#IVDs) and to Notified Bodies – The European Commission has designated five different laboratories in Europe to become European Union reference laboratories (#EURLs) for high-risk in vitro diagnostic medical devices in accordance with Article 100 of Regulation (EU) 2017/746. The Paul-Ehrlich-Institut has been designated in the scopes “Hepatitis and Retroviruses” and “Respiratory Viruses” and provides information on the tasks and current status of the EURLs, among other things. 👉 More information: https://lnkd.in/eVdjV4uf

The treatment of patients with severe COVID-19 following SARS-CoV-2 infection remains difficult. Severe inflammatory reactions and thrombotic complications (blood clots) in particular can be life-threatening. Classic anticoagulants such as heparin often cannot prevent these complications. An evaluation of literature data shows that natural anticoagulants, known as plasma protease inhibitors, are important in the regulation of out-of-control inflammatory and coagulation processes and should be reviewed for their therapeutic benefits. The journal Biologicals reports on the results online ahead of print. Find out more 👉 https://lnkd.in/ewR9_X_7

Information to blood donation facilities on blood and plasma donation with Long COVID – The Paul-Ehrlich-Institut informs blood donation facilities, that the safety of blood and plasma donations is ensured by the Haemotherapy Guideline requirements and the uniform blood and plasma donor questionnaire. 👉 More information: https://lnkd.in/eqqi-hCC

News from regulation – The July #CHMP meeting highlights are online. The Paul-Ehrlich-Institut reports on new recommendations for marketing authorisation, extensions of therapeutic indication and newly published EPARs. 👉 https://lnkd.in/etG2wfGY The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) is responsible for the scientific assessment of the application dossier on the quality, safety and efficacy, including environmental safety, of a new medicinal product for human use as part of the centralised marketing authorisation procedure. The Paul-Ehrlich-Institut is represented in the CHMP as a co-opted member. #Biomedicines #Regulation

Information to applicants – The Paul-Ehrlich-Institut informs applicants from the pharmaceutical industry and academic drug developers about the optimised SNSA (Simultaneous National Scientific Advice) procedure and draws attention to the updated documents and templates. 👉 More information: https://lnkd.in/evat7PYh

Today is World Hepatitis Day – July 28 marks the birthday of Dr. Blumberg, the discoverer of the hepatitis B virus. Hepatitis is an inflammation of the liver caused by type A, B, C, D, or E hepatitis viruses. Liver disease can lead to a number of health problems, some of which can be fatal. HBV and HCV are particularly threatening, leading to chronic diseases in hundreds of millions of people. Together they are the most common cause of liver cirrhosis, liver cancer, and deaths associated with viral hepatitis worldwide. According to estimates by the World Health Organization (WHO), 304 million people worldwide live with a hepatitis B or C infection. Vaccines are available in Europe to protect against hepatitis A and B. The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, performs a variety of tasks connected to the development and provision of safe blood products and safe, effective vaccines to protect against hepatitis infections. Check out which vaccines are available against hepatitis A: https://lnkd.in/enkijjkJ and against hepatitis B: https://lnkd.in/eST7462K #worldhepatitisday #hepatitis

Notification for Applicants and Sponsors of Clinical Trials – The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)) provide recommendations on complex clinical trials in mono-national clinical trials in the early development phase (early phase complex clinical trials). Read the recommendations here 👉 https://lnkd.in/ezeHvYdY #clinicaltrials