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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.

Blood disorder specialists Imara raises $63m

It’s currently in a phase 2 clinical trial, but early data suggests the drug can improve health outcomes and possibly ameliorate disease pathology. ... Meanwhile, Bluebird Bio recently delivered some robust early-stage data from its SCD gene therapy

Latest news

NCI head Sharpless named as interim FDA chief

with efforts to revamp the clinical trial recruitment process and deploy ‘big data’ to interpret trial results.
NICE partially clears Darzalex combo in blood cancer

Some of the cost effectiveness evidence we reviewed suggests daratumumab could notably increase the overall survival of people who have had one previous therapy, but the long-term trial data is ... Imbalances in the type of previous treatments used in
Boehringer’s IL-36-targeting drug tackles rare form of psoriasis

Pustules were completely cleared in three patients within 48 hours after treatment, according to the trial investigators, led by Hervé Bachelez of the Sorbonne Paris Cité Université in France. ... This trial provides long-awaited clinical data that
EMA could follow FDA’s Xeljanz blood clot warning

It says it is now actively examining the trial data and working with Pfizer to better understand the safety signal, its impact on patients, and how the drug should be used. ... The results aren’t great news for Pfizer and Xeljanz, which has been
FDA and Flatiron extend real world evidence collaboration

We believe that regulatory-grade real-world data can help inform our decision-making so that we can provide cancer patients with better care.”. ... genomics data, clinical trial data and RWE.

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Latest Intelligence

Brain power: fresh approaches to Alzheimer’s drug discovery

competitive data, trial recruitment problems, and trial design that is ill-suited to making rapid progress against this elusive disease. ... The first proof-of-concept trial is expected to start in 2019 or 2020, and will include three interventions in
Why precision medicine demands precision engagement

This real-world information can help life sciences organisations understand the benefits and challenges of a treatment outside the controlled clinical trial environment and, together with scientific data, evolve treatments for ... Through this
Drug launches to watch in 2019

data requirements and trial design in groundbreaking therapies. ... for approval in the US and EU for non-metastatic CRPC on the strength of MFS data from the PROSPER trial.
Tackling a formidable foe

Novartis has announced positive phase III trial data for siponimod, a drug for secondary progressive MS, which reduced the risk of a patient’s disability worsening by 21% after three months ... All will be fighting for reimbursement across a squeezed
Stakeholder dialogue in Europe’s adaptive pathways pilot

The use of real-world evidence (RWE) as a complement to clinical trial data to support reimbursement decisions after Conditional Marketing Authorisation (CMA) is granted. ... Efficacy and safety data from early compassionate use programmes to supplement

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Latest appointments

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
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.
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,
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

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
More tell, less sell: HCP-centric comms

Content requested by HCPs[8]:. Journal reprints. Diagnostic instruments. Clinical trial data. ... clinical trial data, disease information, and journal reprints.[8].
New ICMJE Guidelines and their Impact on Biotech

The submission is returned to the authors for being incomplete and the authors revise their submission to include the required elements of a data-sharing statement. ... While the goal of ICMJE of increasing transparency in the reporting of clinical trial
NEW EU DATA PROTECTION REGULATION POISED TO CHANGE DATA PRIVACY LANDSCAPE

The implication is that if a U.S. pharmaceutical manufacturer or biotech company is conducting a trial in Switzerland, for example, the patient data gathered must adhere to the laws set ... IMPLEMENTING SOLUTIONS IN RESPONSE TO THE GDPR. New compliance
The Biosimilar Challenge

The Physicians’ Perspective. Originally many prescribers were reluctant to try biosimilars due to questions around the robustness of clinical trial data and long-term safety.

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