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Biogen announces results from Phase IIIb NOVA study for MS
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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Clinical Development
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FDA Fast Track designation given to mRNA RSV vaccine
Moderna’s mRNA respiratory syncytial virus (RSV) vaccine candidate, mRNA-1345, gains Fast Track designation in adults over 60 years old.
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![AstraZeneca sign and logo on company building exterior - South San Francisco, California, US in 2020 [Credit: Michael Vi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/AstraZeneca-4.jpg)
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AstraZeneca reveals $15.54 billion in revenues in H1 2021
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.
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NICE approves cost-comparison fast-track appraisal pilot
A new approach to the cost-comparison fast-track appraisal process is being piloted this summer for the review of low-risk appraisals.
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FDARA implementation guidance for paediatric studies of molecularly targeted oncology drugs
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).
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LBPs may offer hope to IBS patients in the near future, says report
Live biotherapeutic products (LBPs) are expected to help patients with IBS who currently have no US- or EMA-approved treatments.
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Roche’s Evrysdi significantly improves lives of babies with SMA
The Phase II study of Evrysdi showed significant improvements in survival and motor milestones in babies with type 1 spinal muscular atrophy (SMA).
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Alzheimer’s treatment lowers tau by nearly 50 percent in Phase I trials
Biogen and Ionis announced positive topline data on investigational Alzheimer’s treatment, indicating 50 percent tau protein reduction.
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Regulators call for clinical research to include pregnant and breastfeeding women
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.
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Bayer appoints Head of Research and Early Development for Oncology
Bayer have announced that Professor Dominik Ruettinger will be its new Head of Research and Early Development for Oncology, effective 1 October 2021.
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AI and big data will continue to disrupt pharma sector, says survey
A GlobalData report has revealed the extent to which companies will be using AI and big data in drug discovery and development processes.
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Putting safety at the heart of clinical research outsourcing strategy
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.
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International Society for Stem Cell Research (ISSCR) releases new guidelines
The ISSCR has released updated guidelines for stem cell research and clinical translation of stem cell-based therapies.
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Why it’s high time for psychedelic drug development
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.
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ICMRA and WHO state clinical trial reports should be published without redaction
The International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO are calling on pharma to provide voluntary unrestricted access to trial results data.