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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.

eConsent: Busting regulatory myths

eConsent: Busting regulatory myths

Myth #4: Regulators are hesitant to support eConsent because it carries data security and privacy risks. ... Its capability to improve how consent is collected, to better inform participants and to easily track study progress results in higher quality

Latest news

  • CAR-Ts take centre stage as ASH18 comes to a close CAR-Ts take centre stage as ASH18 comes to a close

    Back in the realm of ‘conventional’ CAR-T, China’s Legend Biotech posted encouraging data from a phase 1/2 trial of its Johnson &Johnson (J&J) partnered anti-BCMA therapy ... Another anti-BCMA player – Poseida Therapeutics – presented

  • Grail to initiate largest ever UK cancer screening study Grail to initiate largest ever UK cancer screening study

    However, the fraction of tumour-derived cfNAs in the bloodstream compared to cfNAs from non-cancerous cells is very small, so the company plans to feed the data collected from the ... trial into its bioinformatics and machine learning algorithms in order

  • ASH18: CAR-T and drugs give new options for multiple myeloma ASH18: CAR-T and drugs give new options for multiple myeloma

    The new data at ASH – from the TOURMALINE-MM3 study – will be submitted to regulators in the hope of extending the use of the drug into the maintenance setting. ... Later today, Amgen will report additional data from a trial of AMG 420, its anti-BCMA

  • AZ’s MYSTIC survival data is in – and it’s a bust AZ’s MYSTIC survival data is in – and it’s a bust

    Imfinzi failed to achieve OS improvement. AstraZeneca has released the overall survival (OS) data from its MYSTIC trial of Imfinzi and tremelimumab in advanced non-small cell lung cancer (NSCLC), and ... The read-out matches the disappointing

  • UniQure skyrockets on haemophilia B gene therapy data UniQure skyrockets on haemophilia B gene therapy data

    UniQure says it will file the new data with the FDA and EMA before the end of the year, and hopes to start dosing patients in a phase 3 trial of ... of uniQure.  “Based on the long-term FIX data from our phase 1/2 trial of AMT-060, where we saw FIX

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Latest Intelligence

  • Tackling a formidable foe 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 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

  • Trust me, I’m from pharma Trust me, I’m from pharma

    It’s not a good look. Fortunately, better compliance with tightened regulations has meant that allegations of bribing doctors or misrepresenting clinical trial data are now extremely rare. ... In the intervening year, two of its biggest players have

  • Bluebird Bio: on the cusp of a gene therapy revolution Bluebird Bio: on the cusp of a gene therapy revolution

    Interim trial data showed the therapy can reduce by 30-60% the sickling of red blood cells, which causes acute pain and organ damage in sufferers. ... data set in their respective indications, and believe they are best in class.”.

  • Brave real world? How healthcare communication needs to adapt Brave real world? How healthcare communication needs to adapt

    the stresses and strains of the real world. So how do we ensure that HCPs, regulators and patients understand and value data that has been collected outside a clinical trial? ... Being able to discuss the value of collecting all data and the limitations

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Latest appointments

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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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