EMA has recommended granting an extension of indication for Velphoro (sucroferric oxyhydroxide) to include control of serum phosphorus levels in children aged 2 years or older with chronic kidney disease (CDK) stages 4-5 or with CDK on dialysis. Patients with severe kidney disease cannot eliminate phosphate from their bodies. This leads to hyperphosphataemia (high blood
U.S. Food and Drug Administration approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the users or their caregivers for use by individuals aged 2 to 6 with type 1 diabetes. The
EMA has published the draft Guideline on registry-based studies for a three-month public consultation. The new draft guidance aims to optimise the use of registry-based studies as a source of real-world evidence. Studies based on patient registries generate real-world evidence that can complement the knowledge gained through pre-clinical studies and clinical trials during the development
The world’s leading independent general medical journal the Lancet started “The Lancet 2020 Campaign on child and adolescent health” with the aim to reiterate the centrality of child survival and wellbeing in global development. Several initiatives have been proposed to achieve this goal. In February, a new WHO–UNICEF Lancet Commission put children firmly at the
The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. A transition period began on 1 February 2020, during which EU pharmaceutical law remains applicable to the UK. The European Medicines Agency (EMA) has made preparations to ensure it continues to deliver on its mission to
The Food and Drug Administration (FDA), in collaboration with the European Medicines Agency (EMA), provided procedural assistance to sponsors and applicants who anticipate submission of paediatric product development plans for the treatment and prevention of COVID-19. In issuing this Common Commentary, the FDA and EMA aspire to streamline administrative processes and facilitate efficient submission of
The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. A transition period began on 1 February 2020, during which EU pharmaceutical law remains applicable to the UK. The European Medicines Agency (EMA) has made preparations to ensure it continues to deliver on its mission to
The European Joint Program on Rare Diseases (EJP RD) is glad to announce its second General Assembly (GA) and Consortium Meeting that will take place from 14 to 18 September 2020 online, due to the current COVID-19 crisis. The EJP RD brings over 130 institutions (including all 24 ERNs) from 35 countries: 26 EU Member
The European Medicines Agency has published for public consultation the ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - questions & answers. The guideline is available at this link. Since the ICH M7 Guideline was finalized, worldwide experience with implementation of the recommendations for
EPTRI (European Paediatric Translational Research Infrastructure), the European project funded within H2020 Infradev-01-2017 call for proposals and coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) reached the end of its exciting journey, which allowed setting the basis for a new important step. The two-years funded project has come to an end, by the preparation