• Regulatory NewsRegulatory News

    MHRA Seeks Input on Patient, Public Engagement

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday opened a twelve-week public consultation to gather input on its approach to engaging the public, patients, caregivers and health care professionals.   “We want to adopt a more systematic approach to listening to and involving patients – ensuring that the patient voice is heard when safety issues, concerning medicines and medical devices, are identified and in the licensing of new medicines,” ...
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    EMA Warns of Dosing Errors With Methotrexate Drugs

    The European Medicines Agency’s (EMA) on Friday released a set of recommendations for health care professionals to follow to avoid dosing errors with methotrexate-containing medicines.   The recommendations come after a review of dosing errors related to the drugs by the agency’s Pharmacovigilance Risk Assessment Committee (PRAC), which was prompted by an Article 31 referral by Spain’s Agency of Medicines and Medical Products (AEMPS) last year.   According to the...
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    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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    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...
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    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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    Recon: Trump Pulls Plan to Eliminate Certain Drug Rebates; Reckitt Benckiser to Pay $1.4B to Settle US Opioid Probes

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US President Trump Withdraws Plan to Eliminate Drug Price Rebates ( NYTimes ) ( STAT ) ( Reuters ) ( WSJ ) ( Politico ) Reckitt will pay $1.4B to settle federal probes into marketing of opioid-addiction treatment ( STAT ) ( The Guardian ) ( Financial Times ) ( WSJ ) Winning the Obamacare Suit Would Be a Disaster for Republicans ( Bloomberg ) ( NYTimes ) Faced wit...
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    FDA Issues Draft Guidance on Inactive Ingredient Database

    The US Food and Drug Administration (FDA) on Wednesday released a draft guidance for public consultation providing recommendations for drugmakers on using the agency’s inactive ingredient database (IID) during drug development.   The IID is an online repository of information about excipients used in FDA-approved products and serves as a replacement for the inactive ingredient guides the agency began disseminating in the late 1980s.   Within the database, FDA pro...
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    Recon: GSK’s Dovato Hits Main Goal in Phase III Study; Trump Signs Executive Order to Boost Home Dialysis, Kidney Transplants

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The FDA's Janet Woodcock talks about some big changes she's pushing for in drug development, and agency reviews ( Endpoints ) ( Fierce ) 23andMe’s chief scientific officer, a star in drug development, is leaving role ( STAT ) ( Endpoints ) DNA-Testing Service Exposed Thousands of Customer Records Online ( Bloomberg ) CDC made a synthetic Ebola virus to test tr...
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    FDA Finalizes Revised REMS Modifications Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized a revision of its guidance on making and submitting modifications and revisions to risk evaluation and mitigation strategies (REMS).   Specifically, the guidance lays out FDA’s policies for REMS modifications and revisions, including what types of changes the agency will consider and the processes and procedures for submitting those changes to the agency.   The 26-page guidance finalizes an earlier vers...
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    Recon: BioNTech Raises $325M for Immunotherapy Pipeline; J&J Partners With Celsius on Single-Cell Sequencing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Judge Blocks Pharma Prices in TV Ad Rule From Taking Effect ( Focus ) ( NYTimes ) ( Reuters ) ( Endpoints ) Pharma defendants invoke SCOTUS in bid to keep prescription data secret ( Reuters ) GOP senators raise concerns over potential deal to lower drug prices ( The Hill ) Judge dismisses J&J’s request to toss out lawsuit over opioids crisis ( The Guardian ) ...
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    Health Canada Consults on Revised Promotion Guidance

    Health Canada on Thursday opened a two-month public consultation on a draft revision of its guidance on the difference between promotional and nonpromotional messages about health products such as drugs and medical devices.   The draft guidance is intended to replace the agency’s current policy on distinguishing between promotional and non-promotional activities, The Distinction Between Advertising and Other Activities , which was first issued in 1996 and updated in...
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    Implantable Devices: Study Looks at Effectiveness of Registries for Long-Term Surveillance

    A new study published in BMJ Surgery, Interventions & Health Technologies finds that registries for high-risk implantable medical devices often contain enough to identify outlier safety or effectiveness issues, but in some cases do not capture data that could identify other functional or quality issues.   According to the authors, registries and coordinated registry networks (CRNs) “offer a promising alternative or adjunct” to preapproval data collection and postappr...