News

KIDS BARI: HERE WE ARE AGAIN!

We are happy to announce that even this year and with an ongoing pandemic, the youths of KIDS Bari have kicked off their activities[ML1] ! On November 27, KIDS BARI went back to work to promote the involvement of young persons and patients in the research and clinical fields to favour the achievement of goals

December 4th, 2020|

EJP RD: JOINT TRANSNATIONAL CALL 2021

The European Joint Programme on Rare Diseases (EJP RD) has launched the EJP RD Joint Transnational Call (JTC) 2021 and will fund multilateral research projects on rare diseases under the EJP-COFUND action. EJP RD has successfully implemented two Joint Transnational Calls since 2019 to further help in coordinating the research efforts of European, Associated and

December 2nd, 2020|

Transparency: EMA exceptional measures for COVID-19 medicines

During the COVID-19 pandemic, the European Medicines Agency (EMA) is implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 that are approved or are under evaluation. EMA is achieving this by shortening its standard publishing timeframes and publishing information it does not normally publish for other medicines.

December 2nd, 2020|

SAVE THE DATE. EU big data stakeholder virtual forum – 15 December 2020

The European Medicines Agency (EMA) organized a forum on 15 December 2020 to address the following objectives: - inform on implementation of the HMA-EMA Big Data Task Force; priority recommendations; - understand stakeholders’ perspectives; - discuss opportunities for stakeholder collaboration and priorities. The EU big data stakeholder forum will be held as virtual meeting. It

December 2nd, 2020|

How IMI can make a difference in lives of children with diseases?

“The Innovative Medicines Initiative is making a difference to children living with paediatric diseases. Children represent 20% of the EU population and yet many of them live with significant unmet medical need. Less than half of all medicines used by children today are approved for paediatric use. And, for many therapies, there is little or

December 2nd, 2020|

FDA Approves Ivacaftor To Treat Babies with cystic fibrosis

Ivacaftor (Kalydeco, Vertex Pharmaceuticals) is already FDA approved to treat cystic fibrosis in patients aged 6 months and older. The new approval was based on data from ARRIVAL, a phase 3, open-label, safety cohort study of six children with cystic fibrosis aged 4 months to less than 6 months. All children had at least one

December 2nd, 2020|

Highlights Paediatric Medicines from EMA

In October 2020 the European Medicines Agency (EMA) expressed positive opinion on the adoption and extension of indication for a number of treatments addressed to the paediatric population. This is the case of Dupixent (dupilumab), for which on 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted an extension to the

December 2nd, 2020|

TEDDY involvement in the EPTRI Italian node

The first General Assembly of the EPTRI (European Paediatric Translational Research Infrastructure) Italian Node (EPTRI-IT) was held online on October 28th, 2020. The 3 hours meeting was attended by more than 60 representatives coming from the 24 Italian Institutions – members of the Node. TEDDY is pleased to announce its involvement in EPTRI-IT that will

December 1st, 2020|

Recommendations by the Enpr-EMA working group on trial preparedness for sponsors, principal investigators and triallists involved in paediatric clinical trials

On 31 August 2020, the Enpr-EMA (European Network of Paediatric Research at the European Medicines Agency) working group on trial preparedness published recommendations on preparedness of medicines’ clinical trials in paediatrics. Enpr-EMA held a two-month public consultation on the draft document from September 2019 until November 2019, with the aim of identifying potential gaps and

December 1st, 2020|