• ReconRecon

    Recon: Gilead, Galapagos in $5.1B Drug Development Deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead to raise stake in Belgian biotech in $5.1bn deal ( Financial Times ) ( STAT ) ( Endpoints ) ( PMLive ) ( Press ) Lawmakers urge Trump administration to alter trade deal or Americans will pay more for drugs ( STAT ) ( Center for Biosimilars ) AstraZeneca's Farxiga fails to get US approval for Type-1 diabetes ( Reuters ) ( Endpoints ) Eton's conjunctiviti...
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    What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains in Revised Guidance

    The US Food and Drug Administration (FDA) on Monday revised its guidance on the electronic common technical document (eCTD) format to note specific cases where the agency believes a submission should be exempted or granted a waiver. As far as what submission types warrant an exemption from eCTD requirements, FDA points to Type III drug master files (DMFs), which provide information on packaging or packaging materials in support of drug, generic drug or biologic applicat...
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    First FDA-Developed Medical Device Development Tool Receives Qualification

    A tissue mimicking material (TMM) for use in the preclinical development and evaluation of ultrasound medical devices became the first medical device development tool (MDDT) developed by the US Food and Drug Administration (FDA) to received FDA qualification.   Device developers can use this MDDT to help test the safety of their high-intensity therapeutics ultrasounds (HITU) devices before moving to clinical trials.   With the TMM’s qualification, the MDDT program ...
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    When FDA and Advisory Committees Disagree: Study Investigates Gaps

    While only about one in five US Food and Drug Administration (FDA) new drug approvals or safety decisions run counter to outside advisory committee advice, a new study published Monday in the Milbank Quarterly looks further into what happens when both sides disagree. Of the 404 advisory committee meetings that involved voting questions (out of a total of 759 meetings between 2008 and 2015), the study looked at 376 meetings, with 271 (72%) for initial product approvals...
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    Why Industry Anticipates a ‘Cliff-Edge’ Scenario With EU MDR/IVDR

    The EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) may cause a “cliff-edge scenario,” meaning a disruption in the supply of certain medical devices and IVDs, industry groups and the European Commission (EC) recently cautioned.   Experts see the potential for such disruptions because of roadblocks in transitioning to the new regulatory framework, including notified body (NB) designation delays. And although these issues have come under the spotligh...
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    German Study Finds Most New Drugs Fail to Improve on Standard of Care

    A study published Wednesday in The BMJ by officials from Germany’s Institute of Quality and Efficiency in Healthcare (IQWiG) finds there is no evidence of added benefit for more than half of the drugs the institute assessed from 2011-2017.   “Although gaps in the therapeutic armamentarium undoubtedly exist, research covering drug approvals since the 1970s suggests only a limited number of new drugs provide real advances over existing drugs. Most studies put the propo...
  • ReconRecon

    Recon: Amgen, Novartis Halt Alzheimer’s Studies After Patients Worsened

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amgen, Novartis abandon two Alzheimer’s drug studies ( Financial Times ) ( Endpoints ) ( Pharmafile ) ( Press ) Nexus to build $250M manufacturing facility in Wisconsin ( BioPharmaDive ) Indivior says Reckitt settlement in U.S. unrelated to its cases ( Reuters ) ‘There’s a lot of screaming into the void’: Toddler’s parents battle for coverage of $2.1 million g...
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    FDA Defends Generic Drug Approvals Despite Dip in June

    Despite just 45 generic drug approvals and 17 tentative approvals in June, the US Food and Drug Administration (FDA) told Focus that the dip­, from an average of about 89 approvals and 23 tentative approvals in the previous eight months, is not due to a specific issue. “FDA approved or tentatively approved more than 900 ANDAs as of June 30, 2019, which is on par with (or above) previous fiscal years,” an FDA spokesperson told Focus . “Approval numbers can vary from m...
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    US and EU Fully Implement Mutual Agreement on GMP Inspections

    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on Friday said they have now fully implemented a plan that will allow member state regulators and FDA to mutually rely on each other’s good manufacturing practice (GMP) inspections of drug facilities. In addition to helping reduce redundancies in manufacturing inspections, the implementation of the Mutual Recognition Agreement (MRA) means that beginning Friday, pharmaceutical companies can sto...
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    Hormonal Contraception: FDA Drafts Guidance on Clinical Trial Recommendations

    As hormonal drugs to prevent pregnancy have evolved over the years, the US Food and Drug Administration (FDA) on Thursday drafted new guidance for drug developers on the recommendations for clinical trials designed to establish clinical effectiveness and safety for such products. In terms of key considerations for clinical trial design features, the six-page draft begins by explaining the recommended enrollment criteria for nonpregnant, premenopausal woman in trials, wh...
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    FDA Revises 1999 Draft Guidance on Population Pharmacokinetics

    The US Food and Drug Administration (FDA) on Thursday released revised draft guidance to help keep sponsors informed on the data and model requirements for population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications. Since the original population PK guidance was published in 1999, FDA says the number of applications relevant for population PK analysis has increased and, “The sophistication and reliability of pop...
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    Canadian Regulator and Regulatory Experts to Speak at 2019 Convergence

    RAPS’ 2019 Regulatory Convergence in Philadelphia will include a session hosted by the Canadian Association of Professionals in Regulatory Affairs (CAPRA). RAPS and CAPRA enjoy a collegial relationship and have collaborated on a number of initiatives in recent years. RAPS is even offering CAPRA members the opportunity to attend this year’s Convergence at the RAPS member rate. This is the second consecutive year CAPRA has hosted a session within RAPS’ signature annua...