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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.

Insmed claims first FDA okay for limited population antibiotic

Insmed claims first FDA okay for limited population antibiotic

For Insmed, the approval marks the end of a 10-year effort to develop Arikayce, and comes on the strength of interim data from an ongoing phase 3 trial which compared

Latest news

  • J&J files ‘breakthrough’ bladder cancer drug in US J&J files ‘breakthrough’ bladder cancer drug in US

    The application is based on data from a phase 2 trial ( BLC2001) which was presented at this year’s American Society of Clinical Oncology (ASCO) meeting. ... Data from mid-stage studies should be available next year, and Incyte has said it hopes to be

  • Viking throws downn gauntlet in NASH battle Viking throws downn gauntlet in NASH battle

    Impressive data in a phase 2 trial caused shares in Viking Therapeutics to almost double yesterday as investors got excited over another candidate for non-alcoholic steatohepatitis (NASH). ... The company has submitted the data for presentation at the

  • Kymriah rejected in DLBCL - but NICE wants to keep talking about cost effectiveness Kymriah rejected in DLBCL - but NICE wants to keep talking about cost effectiveness

    data, making it hard for it to come to clear conclusions about their cost effectiveness. ... This adds to Gilead’s advantage in clinical trial data, where its Yescarta looks to have significantly better rates of overall response rate and complete

  • NICE turns down Opdivo for adjuvant melanoma therapy NICE turns down Opdivo for adjuvant melanoma therapy

    Opdivo was approved for adjuvant treatment of melanoma on the back of data from the CheckMate-238 trial showing that it was superior to BMS’CTLA4 inhibitor Yervoy (ipilimumab) in reducing ... in the KEYNOTE-054 trial reported earlier this year.

  • Gilead optimistic about Yescarta deal in UK Gilead optimistic about Yescarta deal in UK

    Firstly, Kymriah’s pivotal ZUMA-1 trial was a single-arm, open-label study, and a lack of a comparator makes NICE’s cost-effectiveness modelling much harder. ... Secondly, the trial data isn’t yet mature, with the median overall survival (OS) not

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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

  • Clinerion appoints new regional head Clinerion appoints new regional head

    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

  • Sanofi CEO Viehbacher to head EFPIA 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 Eric Green named NIH's data science lead

    Eric Green named NIH's data science lead. Takes role on interim basis as part of expanding plans for data. ... This project offers a data repository with demographics, clinical observations, clinical trial outcomes, adverse events and biomarker data like

  • Almac appoints Charlie Morris as VP new products and services in clinical technologies division 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

  • 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

  • How pembrolizumab will change the management of advanced lung cancer

    Further, the tolerability was in favor of pembrolizumab. We talked Dr Martin Reck about the trial. ... He explains that “ this data will completely change our management of patients with advanced lung cancer”.

  • The Heart of the Matter 7: Reality Dawns

    The challenge is to turn that data into information and information into insight. ... In tandem, as the limitations of the 'gold standard' randomised clinical trial (RCT) data are increasingly exposed, European initiatives such as the Innovative

  • The Heart of the Matter 9: Context is King

    Flagship policy in both Europe and the US is mandating the full disclosure of clinical trial data, while international regulations now dictate data sharing, including anonymised individual-patient data, across all ... Although these approaches are still

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