Results from the NOVA study show every six-week dosing with natalizumab is as effective as every four-week in relapsing-remitting MS.
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Moderna’s mRNA respiratory syncytial virus (RSV) vaccine candidate, mRNA-1345, gains Fast Track designation in adults over 60 years old.
H1 financial results show AstraZeneca’s revenues grew by 23 percent in 2021, with $14.37 billion attributed to activities aside from COVID-19 vaccine sales.
A new approach to the cost-comparison fast-track appraisal process is being piloted this summer for the review of low-risk appraisals.
This article addresses early planning for paediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original New Drug Application (NDAs) and Biological License Application (BLAs) are expected to be submitted to FDA, in accordance with The FDA Reauthorization Act (FDARA).
Live biotherapeutic products (LBPs) are expected to help patients with IBS who currently have no US- or EMA-approved treatments.
The Phase II study of Evrysdi showed significant improvements in survival and motor milestones in babies with type 1 spinal muscular atrophy (SMA).
Biogen and Ionis announced positive topline data on investigational Alzheimer’s treatment, indicating 50 percent tau protein reduction.
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
Bayer have announced that Professor Dominik Ruettinger will be its new Head of Research and Early Development for Oncology, effective 1 October 2021.
A GlobalData report has revealed the extent to which companies will be using AI and big data in drug discovery and development processes.
Pharma companies outsourcing clinical research support without focusing on safety are paying the price. Here, Natalia Vlcek, Pharmacovigilance Manager and EU QPPV at Arriello Group, offers some practical tips for ensuring best practice when it comes to safety in clinical research outsourcing.
The ISSCR has released updated guidelines for stem cell research and clinical translation of stem cell-based therapies.
Here, Dr Matthew McMurray and Dr J Andrew Jones of Miami University explain why psychedelic drugs are attracting R&D as potential treatments for neuropsychiatric and degenerative disorders and how their discovery of an in vivo production technique could enable further advancement.
The International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO are calling on pharma to provide voluntary unrestricted access to trial results data.