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    FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones

    The US Food and Drug Administration (FDA) on Thursday released new draft guidance on its benefit-risk assessment framework for opioids, outlining how the agency plans to compare the effectiveness and safety of new opioids with already approved opioids. The idea for a comparative approval standard, discussed by former FDA Commissioner Scott Gottlieb in March before a Senate committee, hinges on the fact that “FDA believes that there should be a premarket demonstration ...
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    Almost Half of All New Drug Approvals in 2018 Relied on One Clinical Trial

    Back in the 1970s and 1980s, the US Food and Drug Administration (FDA) made clear that at least two adequate and well-controlled studies were necessary to establish a new drug’s effectiveness, except in only the rarest of circumstances. Then in 1997, the Food and Drug Administration Modernization Act was passed, and Congress clarified that FDA may consider “data from one adequate and well-controlled clinical investigation and confirmatory evidence” to approve a new dr...
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    Physicians’ Favorable Views of FDA Drug Approval Standards Underscore ‘Disconnect,’ Survey Finds

    A research letter published in JAMA Internal Medicine on Tuesday highlights the “disconnect” between many physicians’ perceptions of the US Food and Drug Administration (FDA) drug approval process and the “current reality.” The findings are based on a survey aimed at gaging physicians’ attitudes toward FDA drug approval standards and off-label promotion, with a total of 686 survey (48% response rate) respondents listed by the American Board of Internal Medicine Diplom...
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    EMA: No New Patients Should Start Treatment With Lilly’s Lartruvo

    The European Medicines Agency (EMA) on Wednesday told doctors that no new patients should begin treatment with Eli Lilly’s Lartruvo (olaratumab) because a recent study found it is not more effective in combination with doxorubicin for patients with soft tissue cancer when compared to doxorubicin alone. The EMA warning comes just five days after Lilly announced that the Phase 3 study had failed. “Specifically, the study did not meet the primary endpoints of overall ...
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    FDA Finalizes Accelerated Approval Labeling Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on labeling drugs and biologics approved under the accelerated approval pathway.   FDA's accelerated approval program allows the agency to approve products to treat serious or life-threatening conditions based on surrogate or intermediate clinical endpoints "that are reasonably likely to predict clinical benefit." When granting accelerated approval, FDA will require a sponsor to complete postmarket...
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    Tracking Post-Approval Study Completion: Majority On-Schedule but Not Submitted

    The US Food and Drug Administration (FDA) on Thursday released its most recent report tracking the progress that new drug and biologic applicants are making on post-approval studies. The report found that the majority of post-marketing requirements (PMRs) and post-marketing commitments (PMCs) are progressing on schedule, though of those studies that are open (734 NDAs and 156 BLAs are open as of 30 September 2016) and on-schedule, few PMRs for new drug applications ...
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    FDA Approves Eighth Biosimilar, First for Cancer Drug Herceptin

    The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche’s blockbuster breast and stomach cancer drug Herceptin (trastuzumab). Mylan and Biocon’s biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India. First approved in the US in 1998, Herceptin had US sales of more than $2 billion for the 12 months ending 30 September 2017, according to IQVI...
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    EMA Backs Six Drugs, One Biosimilar for EU Approval

    The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval. The six medicines the agency is recommending are: Dr. Falk Pharma's Jorveza (budesonide) to treat eosinophilic esophagitis, a rare inflammatory condition of the esophagus. Jorveza was granted an accelerated assessment and orphan designation; Merck Sharp & Dohme's Pr...
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    FDA Expands Generic Drug Priority Reviews

    Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever – a trend likely to continue. The progress comes as US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday indicated that the agency will expand which abbreviated new drug applications (ANDA) will see priority reviews. "Earlier this year we made changes to how we pri...
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    European Regulatory Roundup: ex-GSK CEO to Chair UK Accelerated Access Collaborative (9 November 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Tasks ex-GSK CEO With Highlighting Drugs Eligible for Accelerated Access Pathway The UK has tasked former GlaxoSmithKline CEO Sir Andrew Witty with highlighting products suitable for its incoming accelerated access pathway (AAP). Products that follow AAP will benefit from support with evidence generation and a more seamless journey to market, features the government ...
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    Asia Regulatory Roundup: China Opens Door to Foreign Trial Data for Accelerated Approvals (10 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Opens Door to Foreign Clinical Trial Data to Accelerate Drug Approvals China is planning to accept data generated from clinical trials run overseas. The proposal is part of a suite of changes put forward by the State Council to boost China’s support for innovative drugs and devices and accelerate their path to patients. The State Council broke its proposals up i...
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    European Regulatory Roundup: Swissmedic Pilots Changes to Accelerate Drug Authorizations (5 October 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Pilots Changes to Accelerate Drug Authorizations The Swiss Agency for Therapeutic Products (Swissmedic) has begun pilot testing changes intended to speed up the drug authorization process. Swissmedic identified revisions to the labeling phase of the process as potentially having the most impact on authorization times by analyzing results from a four-year be...