EMA’s human medicines committee (CHMP) has started a review of a conditional marketing authorisation application for Skycovion, a vaccine for protecting against COVID-19. The applicant, SK Chemicals GmbH, has submitted data on how well the vaccine triggers the production of antibodies against the original strain of SARS-CoV-2, the virus that causes COVID-19. The company also submitted data on the safety and quality of the vaccine.
Ryvu Therapeutics, an innovative biotech company, receives EIB financing to accelerate the development of new therapies to treat severe blood cancers and solid tumours, including further clinical development of the flagship project RVU120.The funding is guaranteed by the European Fund for Strategic Investments, the financial pillar of the Investment Plan for Europe.
The European Commission and Moderna have reached an agreement to better address Member States needs for COVID-19 vaccines for the late summer and winter period. This will ensure national authorities have access to the vaccines, including variant-adapted vaccines if authorised, at the time they need them. This agreement will adapt the originally agreed contractual delivery schedules. Doses originally scheduled for delivery in the summer will now be delivered in September and during the autumn and winter period 2022.
HERA, the European Commission's Health Preparedness and Response Authority, has signed a joint procurement Framework Contract with the company HIPRA HUMAN HEALTH for the supply of their protein COVID-19 vaccine. 14 Member States and countries are participating in this joint procurement, under which they can purchase up to 250 million doses.
Using digital devices, such as smartphones, could help improve memory skills rather than causing people to become lazy or forgetful, finds a new study led by UCL researchers. The research showed that digital devices help people to store and remember very important information. This, in turn, frees up their memory to recall additional less important things. The findings show that using a digital device as external memory not only helps people to remember the information saved into the device, but it also helps them to remember unsaved information too.
EMA’s human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used as third-line treatment for cancers of the ovary, fallopian tubes or peritoneum with a BRCA mutation in patients whose cancer has come back after at least two platinum-based chemotherapies and who cannot have further platinum-based therapy. The recommendation follows the review of final data from the ARIEL4 study, which showed that Rubraca was not as effective as chemotherapy at prolonging patients’ lives.
The Commission has presented a list of headline indicators for monitoring progress towards the EU's environment and climate goals to 2030, as well as the 2050 long-term vision to ‘live well, within planetary boundaries'. Resulting from intense consultations with stakeholders and Member States, the new Monitoring Framework under the 8th Environment Action Programme aims to foster transparency and inform Europeans about the impact of EU climate and environmental policy.
Spain receives an additional €274.9 million from the 2022 tranche of REACT-EU. These resources will support the economic recovery of Spanish regions, help workers and jobseekers acquire skills necessary for the digital and green transition, and improve the access to and functioning of social systems. €137 million are added to the Spanish operational programme of the Fund for Aid to the Most Deprived, and The remaining resources, €137.9 million, are added to the European Social Fund.
The European Union faces the risk of further gas supply cuts from Russia, due to the Kremlin's weaponisation of gas exports, with almost half of our Member States already affected by reduced deliveries. The Commission is therefore proposing today a new legislative tool and a European Gas Demand Reduction Plan, to reduce gas use in Europe by 15% until next spring. All consumers, public administrations, households, owners of public buildings, power suppliers and industry can and should take measures to save gas.
The Commission has approved an amendment to the original advance purchase agreement with the pharmaceutical company Valneva to purchase its vaccine against COVID-19. The joint agreement enables participating Member States to purchase a total amount of 1,250,000 vaccine doses. Given the evolution of the pandemic, and in particular Member States' expected needs for future vaccination campaigns, the amendment ensures that interested Member States who want access to this particular vaccine, will receive the doses they need in August and September.
EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorisation applications (MAAs) for new medicines as well as post-authorisation applications and to explore the practical aspects of the submission and analysis of such data. Raw data constitutes individual patient data from clinical studies1 in electronic structured format that is directly accessible for analysis and visualisation.
We know that we inherit features from our parents and genetic diseases too. European researchers now demonstrate that our DNA also predisposes us to severe bacterial infections. TheHGB-StIC project team discovered a genome-wide enrichment for heterozygous OTULIN variants in patients with severe staphylococcal disease. OTULIN is an enzyme encoded by a gene located on chromosome 5p.
