COVID-19 impact on MDR | European Commission working to postpone MDR for 1-year

by Asphalion

4 years ago
healthcare professionals, covid-19, MDR, European Commission

Due to the outbreak of the pandemic of COVID-19, the Medical Devices (MD) manufacturers all along European Union (EU) have had to increase their efforts to supply all the Member States with the vit...

MDR corrigendum | Manufacturers of Class I MD may have 4 years more to meet the regulation’s standards

by Asphalion

4 years ago
medical devices, regularions, CEU

The Council of the European Union has published a second set of corrections as part of a corrigendum for the EU’s Medical Devices Regulation (MDR) giving manufacturers of Class I devices upclassi...

Q&A document on the implementation of the MDR and IVDR

by Asphalion

5 years ago
legislations, medical devices, European Medicines Agency

The European Medicines Agency (EMA) has recently revised the Question and Answer (Q&A) document that provides practical considerations concerning the implementation of the medical devices (MDR) and th...

World Alzheimer’s Month: reduce your risk of developing dementia

by Asphalion

5 years ago
dementia, develop, Alzheimer

Dementia is a collective name for progressive degenerative brain syndromes which affect memory, thinking, behaviour and emotion. Alzheimer’s disease and vascular dementia are the most common types o...

Luxturna: the first licensed gene therapy for rare inherited eye disorder is recommended by NICE

by Asphalion

5 years ago
inherited retinal dystrophy, eye, NICE, gene therapy

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...

FDA aims to start deactivating outdated drug listing records to ensure the patient safety

by Asphalion

5 years ago
FDA, drug, patient safety

The Food and Drug Administration (FDA) announced its intention to clean the drug listing database from outdated and uncertified records. This action is not limited only to listings for finished dru...

MDR – Less than one year to go

by Asphalion

5 years ago
medical devices, electromedical industries, health ICT, radiotherapy, medical imaging

On 6th June 2019 COCIR (European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry), the European trade association representing the medical imaging, radiotherapy, ...

Drug Device Combinations: Consultation on draft guideline on quality requirements

by Asphalion

5 years ago
EMA, MD, medical devices, Drug Device

The European Medicines Agency (EMA) released a draft guideline on the quality requirements for medical devices (MD) in human medicines that include a MD (known as drug device combinations or DDC) f...

CAR T-cell therapy

by Asphalion

5 years ago
CAR, cell, cancer, therapy

While the success of autologous chimeric antigen receptors (CAR) T-cell medicines cannot be denied, with the recent approvals of Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) pavin...

Asphalion attended CardioReGenix H2020 project kick-off meeting

by Asphalion

5 years ago
gene therapy, programme, CardioReGenix, heart disease, clinical care

The European Union has awarded a grant of 15€ million for a research programme – CardioReGenix – to support new gene therapy approaches for the treatment of heart disease.

Atlas Molecular Pharma receives EMA and FDA Orphan Drug Designation for Congenital Erythropoietic Porphyria with Asphalion support

by Asphalion

5 years ago
discovery, development, treatment of Rare and ultra-Rare Diseases, innovative therapeutics

Atlas Molecular Pharma, a company specialized in the discovery and development of first-in-class, innovative therapeutics for the treatment of Rare and ultra-Rare Diseases, announced that its candidat...

Asphalion: Are you looking for a Horizon 2020 regulatory partner?

by Asphalion

6 years ago
Asphalion, Horizon 2020

Upcoming topics open for the 2018-2019 calls in the area of Health are: understanding causative mechanisms in co- and multimorbidities, combinatorial therapies for complex disorders and approaches to ...