• ReconRecon

    Recon: NICE Backs Revlimid for First Line Multiple Myeloma Treatment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US House Passes Legislation Aiming to Shore Up Health Law and Lower Drug Costs ( NYTimes ) ( The Hill ) ( Politico ) Trump administration backs off a proposal to let Medicare plans exclude certain drugs ( STAT ) ( CNBC ) Gilead CEO parries with congressional Democrats over an HIV prevention pill ( STAT ) ( Endpoints ) AbbVie halts enrollment after brain cancer tr...
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    FDA to Launch Expanded Access Pilot ‘Project Facilitate’ by End of May

    Ahead of the launch of a new pilot aimed at improving patient access to unapproved oncology drugs, dubbed Project Facilitate, the US Food and Drug Administration (FDA) held a public workshop on Thursday explaining its goals for the initiative and to discuss ongoing issues related to expanded access.   According to Richard Pazdur, director of FDA’s Oncology Center of Excellence, the pilot will be rolled out towards the end of May.   “Access to clinical trials and ac...
  • ReconRecon

    Recon: FDA Approves First Blood Thinner for Pediatric Use

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots ( FDA ) Roche: FDA approves drug combo Venclexta plus Gazyva for previously untreated chronic lymphocytic leukemia ( Reuters ) ( Press ) Gilead CEO to testify before a House committee about pricing for its HIV prevention pill ( STAT ) Novar...
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    FDA Updates on Essure Postmarketing Study

    Months after Bayer ended US sales and distribution of its permanent birth control device Essure, the US Food and Drug Administration (FDA) on Wednesday provided an update on the ongoing postmarketing safety review of the device.   “Even though this device is no longer sold, I want to reiterate the FDA’s commitment to regularly communicating with patients and health care professionals about Essure as more information is made available,” said Center for Devices and Radio...
  • ReconRecon

    Recon: Japan Clears $306k Pricetag for Novartis’ Kymriah

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Vertex to pay startup Kymera $70 million in R&D deal ( STAT ) ( Endpoints ) Gilead struck anti-competitive deals to bolster profits on an HIV drug, lawsuit says ( STAT ) ( CNBC ) To Combat Generic Drugs' High Prices, Civica RX To Make 2 Antibiotics ( NPR ) ( STAT ) ( WSJ ) Alphabet is funding a new way to reduce heart disease, the leading cause of death in the...
  • Regulatory NewsRegulatory News

    OPQ Reports on State of Drug Quality in FY2018

    In a report released Monday, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) provides a look at the pharmaceutical quality landscape for drugs and biologics intended for the US market.   The report itself breaks down different metrics related to product quality and manufacturer compliance with current good manufacturing practice (cGMP) to paint a picture of the overall pharmaceutical quality landscape.   While FDA reports an overa...
  • ReconRecon

    Recon: AbbVie, Boehringer Settle Humira Patent Dispute

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AbbVie, Boehringer Settle US Patent Dispute Over Drug Humira ( WSJ ) ( BioPharmaDive ) ( Center for Biosimilars ) ( BI ) ( AbbVie ) Gilead Sciences Statement On Inaccurate Reporting On Truvada ( Press ) How to jump-start a fledgling class of new, cheaper drugs ( Axios ) Trump touts Democratic playbook in crackdown on drug costs ( Politico ) Dems tee up new do...
  • Regulatory NewsRegulatory News

    Study Finds Few Voluntary Postapproval Trials for First Approved Indication

    A study published in JAMA Network Open last week finds that in absence of postmarketing requirements or postmarketing commitments for novel therapeutics approved by the US Food and Drug Administration (FDA), drugmakers rarely conduct voluntary postapproval studies of the drug in the same indication it was initially approved for.   “Over the last decade, the FDA has increasingly shifted toward life-cycle evaluation of drugs and biologics, placing greater emphasis on p...
  • ReconRecon

    Recon: Grail Gets FDA Breakthrough Device Designation for Multi-Cancer Early Detection Test

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Grail, the liquid biopsy startup, picks an approach for its cancer test ( STAT ) ( Press ) ElevateBio launches to help other cell, gene therapy companies lift off ( STAT ) ( Xconomy ) Following Opioid Suits, Family Behind Deadly OxyContin Squabbles ( Reuters ) The inside story of why Amazon bought PillPack in its effort to crack the $500 billion prescription m...
  • ReconRecon

    Recon: Gilead to Donate 2.4 Million Bottles of Truvada to US HIV Prevention Initiative

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead will donate Truvada for HIV prevention, but reaction is mixed ( STAT ) ( NYTimes ) ( CNBC ) ( Politico ) ( AP ) ( Washington Post ) How Insys undermined an FDA effort to protect the public from dangerous opioids ( STAT ) ICER chastises J&J for overpricing depression drug esketamine ‘where there is such need for treatment’( Endpoints ) Puma investors fre...
  • Regulatory NewsRegulatory News

    FDA Finalizes Maximal Usage Trials Guidance for Topical OTC Drugs

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on conducting maximal usage trials (MUsT) to support the inclusion of an active ingredient in an over-the-counter (OTC) monograph.   MUsTs are conducted to determine the in vivo bioavailability of topical drugs and can help FDA understand the potential for systemic exposure to a topically applied active ingredient.   The guidance finalizes a draft version released for comment in May 2018 a...
  • ReconRecon

    Recon: Takeda Offloads Xiidra to Novartis, TachoSil to Ethicon to Pay Down Debt

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Bristol-Myers' Opdivo fails late-stage brain cancer trial ( Reuters ) ( Endpoints ) ( Press ) Generic Drug Stocks are ‘Worst Ever’ ( WSJ ) Nearly One in Two Americans Takes Prescription Drugs: Survey ( Bloomberg ) Trump gambles in push for drug import proposal ( The Hill ) Prescription Opioid Use Plummeted Most on Record Last Year ( Bloomberg ) Addiction Med...