Data

The European Medicines Agency (EMA) has confirmed that the UNICOM’s DADI (Digital Application Dataset Integration) project will now serve as a ‘Plan B’ for the implementation of regulatory data submissions. Amplexor’s Renato Rjavec looks at the opportunities and challenges this presents for pharma companies. A more data-driven way of managing regulated product data, based on […]

New global data analysis from Phesi shows the extent of the impact from the war in Ukraine on clinical development.   Phesi analysed pivotal trials sponsored by pharmaceutical companies that represent the most critical global clinical development activities.   The findings  The findings show that as of March 16, 2022, there were 65,593 recruiting investigator sites globally […]

New results from an observational data analysis of asthma inhaler therapy found that short-acting beta2-agonist (SABA) reliever overuse is a global issue adversely impacting asthma outcomes.1,2   Data from across the SABA Use IN Asthma (SABINA) global programme have been published in The Journal of Allergy and Clinical Immunology: In Practice (JACI: In Practice) and the […]

More than half of all scientific research is irreproducible, and more than 80% of scientific research data is being lost within 20 years. In the biomedical field alone, irreproducible research costs the industry £28 billion (US$38 billion) every year. Megan Thomas talks to Founder of Labstep Jake Schofield, about this issue.  MT: Huge amounts of scientific data […]

Pharmaceutical companies must keep improving Covid-19 treatments in line with new variants without sidelining work in other areas of health, according to new data from YouGov and Informa Pharma Intelligence, a provider for the biopharma industry.   The report  This data, included in Informa Pharma’s ‘Q4 2021 Clinical Trials and the Covid 19 Landscape’ report, is […]

The US Food and Drug Administration (FDA) has approved a long-acting HIV prevention medication for the first time.   The drug  Developed by ViiV Healthcare, the medicine is long-acting cabotegravir injected once every two months. The FDA has approved the medicine for use by adults and adolescents weighing at least 35 kilograms who are at risk of sexually […]

Twist Bioscience has launched Revelar Biotherapeutics to develop and commercialise an antibody that neutralises all known variants of concern of the SARS-CoV-2 virus in preclinical studies.   In addition, Revelar will have the ability to leverage the antibody discovery and optimisation platform of Twist Biopharma to license additional antibodies for up to five targets over the next four years.  Emily Leproust, CEO and co-founder of Twist Bioscience, said: […]

The Comprehensive Resistance Prediction for Tuberculosis International Consortium (CRyPTIC) research project has reportedly collected the largest ever global dataset of clinical M. tuberculosis samples from across the world consisting of 15,211 samples from 27 countries on five continents.  Using a new quantitative test for drug resistance and a new approach which identifies all the genetic […]

Medicine developer CatSci has collaborated with the Cambridge Crystallographic Data Centre (CCDC). CatSci’s experimental expertise in material science combined with CCDC’s informatics tools will offer an integrated solution to customers, adding strategic value from molecule to medicine.  CCDC’s informatics-based services apply big data learnings from over one million published crystal structures to better understand solid forms, which will help to guide CatSci’s experimental […]

Clinical Ink, a clinical trial data and technology company, has acquired Digital Artefacts, a digital endpoint-based technology company.   “The addition of Digital Artefacts now allows us to drive situational awareness because context matters. Data derived from Digital Artefacts can now increase the richness of our partners’ study data through the convergence of passive and active […]

Metabolon’s first offering from its SmartPanel portfolio aims to provide drug discovery and precision medicine researchers with a novel, dynamic process to explore biologically relevant views of metabolomic data in the context of specific metabolic pathways, biological themes, and disease associations.  “The metabolome offers a window into human biology, providing insights on the human body’s response to chemicals and […]

Listen to this article on the DDW Podcast: Karen Ooms, Executive Vice President and Head of Statistics with Quanticate, argues that analysing data from real-life patients has finally come of age.  Statistical consultants have, for a long time, tried to convey to the pharmaceutical industry the merit of using real world data (RWD) to help create more efficient trial designs […]

Scientists from Queen’s University Belfast have developed a computer-aided data tool that will predict novel sites of binding for potential drugs that are more selective, leading to more effective drug targeting, increasing therapeutic efficacy and reducing side effects. The data tool or protocol will uncover a novel class of compounds – allosteric drugs in G […]

The life sciences data landscape is growing in complexity and scale, with organisations generating increasingly high volumes of data. Yet, these data are still stored and searched using outdated methods. As a result, there are vast amounts of unstructured data stored in various siloed locations. Vladimir Makarov, Consultant at Pistoia Alliance, discusses this challenge and […]

Listen to this article on the DDW Podcast: Chris Sigley, CEO of Arkivum, says the transformation of clinical trials demands a transformed approach to trial data  The pandemic has created manifold challenges for clinical trials, but it has also proved a transformational force. The life sciences sector has succeeded in making a virtue of necessity as it […]

Medidata’s Rave Imaging, the company’s cloud-based, secure clinical trial imaging management platform, has now supported more than 1,000 imaging studies.   Rave Imaging processes more than 100 million images annually. The technology provides real-time visibility into imaging-related trial activities to enhance study efficiency.   Paul McCracken, VP and Head of Medical Imaging (IMI) at ICON Clinical Research, said: “We’ve leveraged […]