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    FDA Warns CBD Seller, HCT/P Maker and Indian Drugmaker

    In the latest batch of warning letters from the US Food and Drug Administration (FDA), the agency warns a major cannabis seller for making unsubstantiated therapeutic claims about its cannabidiol (CBD) based products, a US-based biotech company over human cell, tissues, and cellular and tissue-based products (HCT/P) violations and an Indian drugmaker for good manufacturing practice (GMP) violations.   Curaleaf Holdings   In its warning letter to Curaleaf Holdings, ...
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    Recon: Senate Finance Reaches Deal on Drug Pricing Legislation, Markup Set for Thursday

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmaker Group Boosts Lobbying as Push to Lower Prices Stalls ( Bloomberg ) Grassley, Wyden reach deal to lower drug prices ( The Hill ) ( Politico ) ( Reuters ) ( STAT ) ( Senate Finance ) ( PDPRA ) Pelosi aide: Major bill to lower drug prices coming in September ( The Hill ) How Alex Azar sees Trump’s health strategy now ( Politico ) Frequency Therapeutics...
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    FDA Finalizes Combo Product Postmarket Safety Reporting Guidance

    The US Food and Drug Administration (FDA) on Monday finalized guidance explaining postmarket safety reporting (PMSR) requirements for combination products and their constituent parts.   "In the past decade we have seen a marked increase in interest from manufacturers who seek to develop medical products that combine devices, drugs and/or biologics,” said FDA Principal Deputy Commissioner Amy Abernethy, noting that the newly finalized guidance will “help applicants bett...
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    Recon: Gilead Licenses Durect Long-Acting Injectable Technology; FDA Rejects Biohaven’s ALS Drug Over Manufacturing Concerns

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Busy Gilead crew throws struggling biotech a lifeline, with some cash upfront and hundreds of millions in biobucks for HIV deal ( Endpoints ) ( Press ) FDA Approves First Lyrica Generics From 9 Sponsors ( Focus ) The Four Ordinary People Who Took On Big Pharma ( NYTimes ) Amarin's $400M-plus offering put investors on edge. Is a buyout off the table? ( Fierce )...
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    Recon: Amgen and Allergan Launch Avastin and Herceptin Biosimilars

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amgen and Allergan Launch Mvasi and Kanjinti, the First Anticancer Biosimilars, in the United States ( Center for Biosimilars ) ( Endpoints ) ( Fierce ) ( Press ) Canada warns US against drug import plans, citing shortage concerns ( Reuters ) Biotech enters an era of ‘platform’ dominance ( STAT ) Second opioid distributor charged over role in US drug epidemic ...
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    FDA to Study Physicians’ Interpretations of Drug Information

    The US Food and Drug Administration (FDA) on Thursday said its Office of Prescription Drug Promotion (OPDP) will conduct a study to determine how factors such as information source, graphical presentations and time can influence physicians’ interpretation of information about prescription drugs presented in scientific journals versus promotional materials.   The study will also look at how the level of methodological rigor of the underlying data impacts physicians’ int...
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    Recon: Novartis Sets Aside $700M to Settle US Bribery Suit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis Sets Aside $700 Million to Settle Bribery Allegations ( WSJ ) ( STAT ) ( Reuters ) Fraud conviction of ‘pharma bro’ Martin Shkreli upheld by federal appeals court ( CNBC ) Kronos, a startup led by Gilead alumni, raises $105 million in latest mega-round ( STAT ) Elizabeth Holmes Wins Judge’s Backing in Getting FDA Documents Faster ( Bloomberg ) ( Law36...
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    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...