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trial data
This page shows the latest trial data news and features for those working in and with pharma, biotech and healthcare.
Roche's checkpoint inhibitor fails pivotal urothelial cancer trial
Phase 3 trial shows no effect on disease-free survival and misses its primary endpoint. ... A phase 3 trial of Roche’s checkpoint inhibitor Tecentriq (atezolizumab) in muscle-invasive urothelial cancer (MIUC) has missed its primary endpoint.
Latest news
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Novartis gets EU approval for multiple sclerosis therapy Mayzent
Novartis has generated data to suggest sphingosine 1-phosphate receptor modulator Mayzent is such a drug, enabling it to win approval in the US, Australia and now the European Union. ... The approvals are underpinned by data from a clinical trial that
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J&J pushes to expand Imbruvica label after clinical success
J&J is filing to expand the label on the strength of data from a clinical trial that compared Imbruvica and rituximab to the chemo-immunotherapy FCR in 529 previously untreated
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Novartis links up with NHS for speedy access to cholesterol drug inclisiran
NHS clinical trial. ... The clinical trial will utilise NHS data to identify patients across the country who are at risk of heart disease, and who have had no luck with conventional treatment regimens, including
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FDA clears Blueprint’s $32k-per-month GI cancer drug
Blueprint claimed the approval on the strength of a phase 1 trial – called NAVIGATOR – which showed that Ayvakit achieved tumour shrinkage in 84% of 43 patients with this mutation. ... The FDA’s decision has been delayed by three months as
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Almirall eyes $62m takeover of multicytokine specialist Bioniz
The terms of the deal are an initial payment of $15m, which gives Almirall an option to acquire Irvine, California-based Bioniz outright once data from a phase 1/2 trial
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Latest Intelligence
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Leading AstraZeneca’s return to growth in Europe
Having said that, in essence all healthcare systems want the same thing: data that proves your product produces the desired clinical outcomes – not only from clinical trial data, but also in ... This is the kind of challenge you come up against when
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Mastering data protection in the pharma industry
for example, safety reporting, archiving of master files and disclosure of clinical trial data. ... Secondary use is the processing of personal data for scientific purposes outside the clinical trial.
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European biotech: a new generation of leaders emerges
It had promising new trial data unveiled in May this year for its lead candidate the anti-CD19 antibody tafasitamab (MOR208), and an FDA filing expected by the end of this
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The evolution of real-world studies
In the document, the EMA stated that it is fostering an ‘adaptive approach’ that uses real-world data to supplement clinical trial results. ... Ibrance gained a new approval based on data from EHRs and other real-world sources.
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Streamlining clinical trials – why better data use is key
Blockchain is one possible trial data management solution. The technology creates a digital record of products or information as it is exchanged. ... Trial training. Patrick Pilch from BDO also sees collaboration and the establishment of common standards
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Latest appointments
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Clinerion appoints new regional head
Bariş Erdoğan takes up new role at the clinical trial data firm. ... Swiss-based clinical trial data firm Clinerion has appointed Bariş Erdoğan as its new regional head in a role that focuses on the expansion of its activities in Eastern Europe, the
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Sanofi CEO Viehbacher to head EFPIA
One of the most pressing matters for EFPIA is the seemingly inevitable trend towards transparency of trial data, and Viehbacher has already commented on the subject.
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Eric Green named NIH's data science lead
Dr Eric Green, current director of the National Human Genome Research Institue (NHGRI), is to serve as the first associate director for data science at the US National Institutes for Health ... This project offers a data repository with demographics,
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Almac appoints Charlie Morris as VP new products and services in clinical technologies division
According to the company, which provides services to the pharma industry, he will oversee the development of its IXRS technology to manage patients, supplies, and clinical trial data.
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Latest from PMHub
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Understanding the evolving CAR-T market
The clinical data readout for the AUTO5 trial showed that it “may not be differentiated from more advanced competitor programmes.” The trial has been halted and Autolus is instead focusing on
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The relevance of patient perspectives to value: Patient Involvement in Health Technology Assessment
gains that are not captured in clinical trial data. ... Today, patient preference data from rigorously conducted studies are providing decision-makers with a wider pool of views on the outcomes that patients value.
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Nucleus Global launches Nucleus POLAR™, a state-of-the-art expert search engine and engagement management tool
Nucleus POLAR is a fast, efficient and comprehensive way to identify and map external experts, providing expert profiles that combine publications, clinical trial and transfer of value data sets. ... We designed and built Nucleus POLAR ourselves using
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Havas Lynx Group launches white paper on Clinical Trials Day to address $40bn clinical trials challenge
This approach puts the patient front and centre of the trial and seamlessly uses data technology and media to reduce the time and cost of finding and retaining patients. ... Patient Centricity on Trial’ reinforces this strategy and outlines six main
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Three key development areas in the management of multiple sclerosis
Clinical trial and real-world data supporting the efficacy of disease-modifying therapies in newly diagnosed and early MS were presented at the ECTRIMS congress. ... The data showed that the majority of patients remained free from confirmed disability
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- Lilly will aim for one $1bn-$5bn deal per quarter in 2020
- Novartis gets EU approval for multiple sclerosis therapy Mayzent
- Immuno-oncology, personalised medicine continues to drive pharma sector
- NICE leaves the ‘the NHS door’ open despite rejecting Bayer’s Vitrakvi
- FDA delays decision on Intercept's NASH drug by three months
- Novartis gets EU approval for multiple sclerosis therapy Mayzent
- New coronavirus sees drug developers scramble to develop a vaccine
- Sanofi completes acquisition of immuno-oncology specialist Synthorx
- Roche's checkpoint inhibitor fails pivotal urothelial cancer trial
- Epizyme wins FDA approval for epithelioid sarcoma treatment
- Pharma Brand Planners' Blog (Part 8)
- Happy Chinese New Year 2020 - The Year of The Rat
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- In this white paper, he breaks down the pricing options available to you, shares stories from his extensive experiences, and talks you through how to better define your pricing, step-by-step....
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