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FDA`

This page shows the latest FDA` news and features for those working in and with pharma, biotech and healthcare.

Entering the era of digital trials

Entering the era of digital trials

Clinical trial burdens affect study investigators, too. Around 40% of FDA-registered investigators stop running clinical trials every year, according to the Tufts Center for the Study of Drug Development. ... Yet, while technology helped in some ways, it

Latest news

  • Pfizer claims rapid FDA nod for Lorbrena Pfizer claims rapid FDA nod for Lorbrena

    Pfizer claims rapid FDA nod for Lorbrena. Green light is latest in a string of cancer drug approvals. ... However the approval is a conditional one, meaning that the FDA will continue to monitor results from further trials.

  • Digital Trials Digital Trials

    It lacks the flexibility, analytic power and speed required to develop complex new therapies targeting smaller and often heterogeneous patient populations. ... sets. Artificial Intelligence and machine learning can generate new insights and digital

  • Roche’s new flu pill Xofluza approved in US Roche’s new flu pill Xofluza approved in US

    Roche’ s new flu pill Xofluza approved in US. Hasn't shown superiority to Tamiflu. ... The FDA has approved Roche’s new flu treatment Xofluza (baloxavir marboxil), the first new antiviral drug in nearly 20 years.

  • AcelRX’s potent opioid tablets set to win FDA backing for pain relief AcelRX’s potent opioid tablets set to win FDA backing for pain relief

    This is good news for the company, which saw the FDA reject its new drug application last year. ... If given the final OK, the company notes that the drug would be the first new opioid treatment approved this year by the FDA.

  • Leadiant gets FDA OK for bubble boy disease drug Leadiant gets FDA OK for bubble boy disease drug

    Leadiant gets FDA OK for bubble boy disease drug. New therapy will rival Orchard's Strimvelis. ... Italy’s Leadiant Biosciences has claimed FDA approval for a new drug for adenosine deaminase severe combined immune deficiency (ADA-SCID) – also known

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Latest Intelligence

  • Retaining reader value in plain language summaries of clinical studies Retaining reader value in plain language summaries of clinical studies

    Other, ongoing logistical challenges include the need to establish standard operating procedures (SOPs) for handling and processing PLSs, and to build templates for forming the content. ... The US FDA has also issued a draft document for consideration in

  • Cancer immunotherapy: What's on the horizon? Cancer immunotherapy: What's on the horizon?

    Opdivo after standard treatment of early-stage lung cancer can reduce recurrences and help patients live longer by killing tumour cells remaining after surgery and standard chemotherapy. ... article – but, as recent experience with Incyte and Nektar

  • 30 women leaders in UK healthcare (part 3) 30 women leaders in UK healthcare (part 3)

    2004. Fifteen years on, the company’s lead product candidate, Lynovex, for the treatment of acute pulmonary exacerbations in Cystic Fibrosis, was recently granted FDA Fast Track Designation. ... I am focused most on how to make the average person

  • Significant figures Significant figures

    US regulators at the FDA have recognised the treatment’s potential, handing it breakthrough and fast-track status. ... Offering an on-label treatment. The current standard of care for treating patients with NTM lung disease consists of a triple

  • The good, the bad and the ugly The good, the bad and the ugly

    The main drivers of revenue for Roche are well-established, standard-of-care blockbuster oncology drugs including Rituxan, Herceptin and Avastin. ... The data this article was based on is available in full online: pmlive.com/top_pharma_list.

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