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    EMA Suspends Picato Authorization, Confirms Limits for High-Strength Estradiol Creams

    The European Medicines Agency (EMA) is following a recommendation from its Pharmacovigilance Risk Assessment Committee (PRAC) this week to suspend the marketing authorization for Leo Pharma’s actinic keratosis cream Picato (ingenol mebutate), while the agency investigates reports of increased rates of skin cancer associated with the drug.   The suspension follows PRAC’s investigation of Picato’s safety last year after multiple studies showed a higher rate of skin can...
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    Recon: FDA Panel Split on Durect Non-Opioid Painkiller; Novo’s Ozempic Gains CV Indication

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA panel split over approval of Durect's non-opioid painkiller ( Reuters ) ( Endpoints ) Republican FTC commissioner says she supports Medicare negotiating drug prices ( The Hill ) ( STAT ) Novo Nordisk's diabetes pill Rybelsus to be covered by Express Scripts ( Reuters ) Novo Nordisk's blockbuster Ozempic wins FDA label boost with CV indication ( Endpoints )...
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    FDA Warns of Potential Contamination With Some Cardinal Health Surgical Gowns

    The US Food and Drug Administration (FDA) on Thursday advised health care providers to stop using certain Cardinal Health Level 3 surgical gowns and PreSource procedural packs due to possible product contamination.   “Cardinal Health recommends, and the FDA agrees, that customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include these surgical gowns because the manufacturer cannot provide assurance the product...
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    FDA Recognizes New Version of ISO 14971, More Than 100 Other Consensus Standards

    The US Food and Drug Administration (FDA) in late December recognized the newly revised International Organization for Standardization (ISO) risk management standard for medical devices, ISO 14971:2019, along with more than 100 other consensus standards.   The move came shortly after ISO released the new version of the standard, now in its third revision, and extended FDA recognition to dozens of other consensus standards developed by ISO, the Association for the Adv...
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    Recon: BioMarin Eyes $2-3M Price for Hemophilia Gene Therapy as Other Gene Therapies Test Europe’s Willingness to Cover Them

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US BioMarin Explores Pricing Experimental Gene Therapy at $2 Million to $3 Million ( WSJ ) Neon Therapeutics makes one last retreat, selling itself cheap in a bargain basement M&A deal ( Endpoints ) ( BioPharmaDive ) Hedge fund veteran looks to cash in on biotech boom ( Financial Times ) Pharma execs pitch ideas at JPM to lower drug costs. None include dropping t...
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    EMA: ISO Side Effect Reporting Format Mandatory by Mid-2022

    The European Medicines Agency’s (EMA) management board last month agreed to make the International Organization for Standardization’s (ISO) individual case safety report (ICSR) format mandatory for suspected adverse reaction reporting to EudraVigilance beginning 30 June 2022.   The format, ISO/HL7 27953-2:2011 , is based on the International Council for Harmonisation (ICH) E2B(R3) guideline on data elements for transmission of ICSRs.   “Compared to the older rep...
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    FDA Calls for Switch to New Duodenoscopes

    After clearing the first single-use duodenoscope last month , the US Food and Drug Administration (FDA) on Wednesday called on hospitals and healthcare providers to transition away from older, infection-prone duodenoscopes to newer models with disposable designs.   Over the last three years, FDA has also cleared duodenoscopes with single-use components such as end caps and elevator pieces , aimed at reducing the risk of infection, and other companies have said they...
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    Recon: Nektar Withdraws Opioid NDA After FDA Panel Votes Unanimously Against Approval

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Nektar withdraws NDA for opioid after FDA panel's unanimous vote against it ( Reuters ) ( Endpoints ) ( Press ) FDA staff highlights neurological safety concerns with Durect's pain drug ( Endpoints ) More Than 100 Billion Pain Pills Saturated The Nation Over Nine Years ( Washington Post ) New York drug distributor exits opioids after admitting role in crisis (...
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    Law Firm Challenges FDA’s Crackdown on Pharmacogenomics Data

    Law firm Hyman, Phelps & McNamara (HP&M) last week filed a citizen petition on behalf of the Coalition to Preserve Access to Pharmacogenomics (PGx) Information, requesting that the US Food and Drug Administration (FDA) allow laboratories to provide gene-drug interaction information in genetic test reports.   Background   The petition comes after FDA in 2018 and 2019 took action to crack down on unapproved genetic tests that offered gene-drug interaction information...
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    Recon: Novartis, NHS Reach Deal on Yet-to-Be Approved Heart Drug Inclisiran; Roche Aims to Undercut Rivals With SMA Drug Pricing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US All talk, no M&A makes for a down JPM Day ( STAT ) ( Pink Sheet -$) Roche aims to 'underwhelm' on SMA drug price to challenge rivals ( Reuters ) ( Endpoints ) GlaxoSmithKline CEO expects to get ‘at least’ six drug approvals from the FDA in 2020 ( CNBC ) Eyeing more data, Livongo will integrate continuous glucose monitor into diabetes coaching program ( STAT ) ...
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    Do FDA’s Reforms Need Reforming? Report Looks Back on 4 Decades

    A new report appearing in JAMA on Tuesday outlines why the reforms at the US Food and Drug Administration (FDA) over the past four decades may need further changes.   The most significant of those changes, according to the authors, include FDA’s commitment to review applications for new drugs and biologics in less time; the creation of expedited review programs at FDA, including priority review, fast track, breakthrough therapy designations and accelerated approval; ...
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    Stryker Petition Pushes FDA to Exempt Powered Wheel Stretchers From 510(k) Requirements

    The US Food and Drug Administration (FDA) on Monday issued a final order exempting powered wheeled stretchers from premarket notification (510(k)) requirements in response to a citizen petition filed by Stryker Medical last July.   The agency previously exempted certain products under five different product codes from premarket notification requirements in October. In 2017, FDA finalized an order exempting 1,003 types of Class II devices from premarket notificati...