IT & Data Management

The Committee of Ministers for the Council of Europe has recommended that Member States compile information on the usage and supply of tissues and cells so that final users can receive them right away. The Council emphasized in a...

After more than 10 years of preparation, the new Identification of Medicinal Products (IDMP) standard is set to go live in 2023. IDMP facilitates the unique identification of medicinal products in an effort to promote global harmonization of data,...

A group of Food and Drug Administration advisers has recently come out in favour of a carefully monitored ALS drug, increasing the likelihood that the agency will approve it in the coming weeks. The expert group voted 7-2 in favour...

A third workplan with measures due by 2025 has been released by the joint Big Data Steering Group of the European Medicines Agency (EMA) as well as the Heads of Medicines Agencies (HMA). The new strategy, according to EMA, will...

Positive top-line statistics from Cyclerion Therapeutics' clinical investigation of CY6463 for the treatment of cognitive impairment associated with schizophrenia have been released. It concerns people with stable schizophrenia who are taking a stable dose of a single atypical antipsychotic...

Real-world evidence (RWE) should be included in regulatory decision-making, according to a declaration backed by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The International Coalition of Medicines Regulatory Authorities (ICMRA) released a...

Shimadzu’s new ultra-high performance liquid chromatography system is designed to solve common problems in biopharma analysis. Shimadzu launched its new Nexera XS inert, a bioinert and biocompatible ultra-high performance liquid chromatograph (UHPLC), in July 2022. The system is designed to...