A draft NICE guidance recommends Voretigene Neparvovec (also called Luxturna) to treat people with vision loss caused by inherited retinal dystrophy from confirmed RPE65 gene mutations who have enough viable retinal cells.
The Food and Drug Administration (FDA) announced its intention to clean the drug listing database from outdated and uncertified records.
The FDA and the EMA are aligned in more than 90% of marketing authorizations (MA) for new drugs, according to a new study from EMA and FDA officials comparing 107 new medicine applications at the two agencies between 2014 and 2016.
Last week, Aspahlion decided to collaborate with Aspen Pharmacare Spain in their campaign to help the the Fundació Banc dels Aliments de Barcelona in its food collection campaign “El Hambre No Hace Vacaciones”.
Asphalion’s LinkedIn community now has 10,000 followers! Today, we are celebrating reaching this milestone by having a special breakfast with all of Asphalion’s employees.
From 1st September 2019, all new Master Files submitted to Health-Canada must be in eCTD format, in addition, when converting MFs from non-eCTD format to the eCTD format, the entire MF must be provided in the first eCTD transaction, as a baseline requirement.
Last week, the Spanish Agency of Medicines and Medical Products (AEMPS) announced it’s notified body (NB) 0318 has begun the process to become designated as NB under the European Union’s medical device regulation (MDR).
On 6th June 2019 COCIR, the European trade association representing the medical imaging, radiotherapy, health ICT and electromedical industries, has published a document summarizing the current status in MDR implementation, which still shows little progress in a number of critical aspects.
In Asphalion, we have always been focused on helping to create a healthy, supportive, and safe work environment. That’s why we promote health and wellness programs to help and encourage our workers to develop healthy lifestyle practices.
A new version of the MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES has recently been published by the EU Commission (version 1.22, 05-2019).
Si necesitas saber qué tipos de bases de datos existen para Farmacovigilancia y cómo garantizar las seguridad, integridad y trazabilidad de los datos, no pierdas nuestro próximo webinar que tendrá lugar el día 28 de Junio de 11-12 horas.
On 12 & 13 June, Sónia Lopez, Qualified Person Responsible for Pharmacovigilance at Asphalion, and Núria Cabello, Senior Drug Safety Officer at Asphalion, will be participating in the International Pharmacovigilance Day conference organized by LS Academy.
On 03.06.2019 the European Medicines Agency released a draft guideline on the quality requirements for medical devices (MD) in human medicines that include a MD for a 3-month public consultation, as part of a series related to the European’s medical devices regulation.
We can either provide you a full integrated support (from lab to market) or a tailored support as per you specific needs, at any stage of development or during post-approval lifecycle of Human Medicinal Products.
16 countries, 36 among universities, SMEs and research institutions across Europe, Israel and the United States are the protagonists of the EU-H2020 funded research that is being presented today at the European Chapter Meeting 2019 of the Tissue Engineering and Regenerative Medicine International Society (TERMIS).
On Wednesday, the Germany-based company TÜV Süd became the second notified body (NB) to be designated and notified under the EU Medical Devices Regulation (MDR), which goes into effect next May.
Recently published presentations and recordings of the EMA workshop on support to quality development in early access approaches, such as PRIME and breakthrough therapies.
A new gene therapy study in New England Journal of Medicine reports positively on the use of a self-inactivated lentivirus supplemented by an insulator and a codon-optimised human common γ chain gene to treat SCID-X1 disease.