• Regulatory NewsRegulatory News

    Amarin Plans Citizen Petition to Block Synthetic EPA in Supplements

    Amarin, maker of the fish oil-based triglyceride lowering drug Vascepa (icosapent ethyl), says it plans to file a citizen petition “within weeks” in an attempt to block companies from marketing products containing similar synthesized ingredients as dietary supplements.   Icosapent ethyl, the active ingredient in Vascepa, is a highly purified form of eicosapentaenoic acid (EPA) that was first approved by the US Food and Drug Administration (FDA) in 2012 to lower trigl...
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    Recon: FDA Approves Merck’s Antibiotic Recarbrio to Treat Complicated Infections

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck's treatment for urinary, abdominal infections gets FDA approval ( Reuters ) ( Endpoints ) ( FDA ) ( Press ) Merck urges caution on use of its newly approved antibacterial ( BioPharmaDive ) Pharma deploys its top guns to Capitol Hill as senators mull drug pricing package ( STAT ) States Are Making Progress on Opioids. Now the Money That’s Helping Them May...
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    EC Revises Drug Safety Features Q&A

    The European Commission last week issued a revised questions and answers guideline on implementing safety features for medicinal products detailed in Commission Delegated Regulation (EU) 2016/161 .   The revised document includes three new questions and answers as well as one revised answer from the previous version.   New and Revised Questions   The three new questions are covered in sections 3.7, 5.10 and 8.10, while the only revised question can be found in...
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    FDA Warns Strides Pharma for Uncontrolled Document Shredding

    The US Food and Drug Administration (FDA) warned Indian generic drugmaker Strides Pharma earlier this month over good manufacturing practice (GMP) violations at its Puducherry facility that included uncontrolled shredding of documents and inadequate investigations into out-of-specification (OOS) test results.   In a securities disclosure issued on 2 July, Strides acknowledged receiving the warning letter but said that the letter will not impact production of six FDA ...
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    Recon: Roche’s Genentech Strikes Deals With Skyhawk, Sosei Heptares and Convelo Therapeutics

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How pharma, under attack from all sides, keeps winning in Washington ( STAT ) 2020 candidates throw punches at drug industry ( Politico ) ( BioPharmaDive ) Democrat Harris unveils plan to lower drug costs, put 'people over profit' ( Reuters ) ( The Hill ) ( Washington Examiner ) ( Harris ) Democratic chair: Medicare negotiating drug prices not moving before Au...
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    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...