• Regulatory NewsRegulatory News

    EMA Finalizes Clinical Development Guideline for New Gout Treatments

    The European Medicines Agency (EMA) on Thursday issued a guideline setting its expectations for the clinical development of new urate-lowering therapies (ULT) and anti-inflammatory drugs to treat gout.   The 14-page guideline comes less than a year after EMA’s Committee for Medicinal Products for Human Use (CHMP) released the draft version for consultation and seven years after the agency published a concept paper highlighting the need for such guidance.   Whil...
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    Recon: FDA Panel Votes Against Jardiance as Add-On to Insulin in Type 1 Diabetes; Congo Begins Rollout of J&J Ebola Vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA panel votes against Lilly-Boehringer Ingelheim's diabetes drug ( Reuters ) ( Endpoints ) ( Pink Sheet -$) ( Press ) AstraZeneca, Merck win red carpet treatment at the FDA as a 3-time loser seeks speedy OK for rare tumors ( Endpoints ) ( Press ) Sarepta picks up a slate of preclinical gene therapy programs, seeding new StrideBio deal with $48M upfront ( Endp...
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    FDA Finalizes Guidance on Handling Device Export Certificate Denials

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining how the agency handles denials of requests for a certificate to foreign government (CFG) for medical devices and how to request a review when a CFG is denied.   Such certificates are used to assure foreign governments that a device being exported complies with US regulations, such as the Quality System Regulation (QSR).   The eight-page guidance finalizes a draft version issued i...
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    Recon: Vertex CF Drugs Win Coverage in Wales; Merck Buys San Diego Biotech Calporta for up to $576M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA still allowing secret reports on medical devices ( Star Tribune ) NY insurance regulator notifies opioid makers, distributors of enforcement action ( Reuters ) Google’s ‘Project Nightingale’ Triggers Federal Inquiry ( WSJ ) ( STAT ) Lawmakers Scold Google’s ‘Project Nightingale’ Over Health-Data Privacy ( WSJ ) ICER draws new gene therapy pricing framewor...
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    EMA Officials: Regulatory, HTA Advice Sped Access to Bluebird’s Gene Therapy

    Officials from the European Medicines Agency (EMA) say that advice from the agency and health technology assessment (HTA) bodies played a “key role” in speeding access to Bluebird Bio’s gene therapy Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene).   “Groundbreaking therapies such as Zynteglo present specific challenges for those who assess their benefits and risks for the initial authorisation and those who assess their value as a basis for pricing and r...
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    Recon: Solid Biosciences Gene Therapy Study Put on Hold Again; Lonza CEO to Depart After Less Than a Year

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Google’s ‘Project Nightingale’ Gathers Personal Health Data on Millions of Americans ( WSJ ) ( Reuters ) ( NYTimes ) ( CNBC ) Shares of Amarin jump after FDA staff review on fish-oil drug ( Reuters ) ( STAT ) ( Endpoints ) Solid Biosciences gene therapy trial put on hold for second time, shares slump ( Reuters ) ( STAT ) It’s tiny biotechs — not big drug maker...
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    IMDRF Offers Three Final Clinical Guidelines

    The International Medical Device Regulators Forum (IMDRF) recently released three final documents on clinical evaluations, clinical investigations and clinical evidence for medical devices, replacing earlier versions of the documents developed by the Global Harmonization Task Force (GHTF).   Clinical Evaluations   In the 30-page document on clinical evaluations , IMDRF defines a clinical evaluation as “a set of ongoing activities that use scientifically sound meth...
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    Recon: FDA Rejects Lipocine Testosterone Drug for the Third Time; Roche SMA Drug Hits Goal in Pivotal Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Democratic presidential hopefuls want to take on pharma. Here’s how they’d do it ( STAT ) Voters Say Congress Needs to Curb Drug Prices, But Are Lawmakers Listening? ( KHN ) Celgene's drug for anemia in beta thalassemia priced at $3,441/ 25 mg vial ( Reuters ) ( Endpoints ) ( FDA ) FDA rejects Lipocine's testosterone drug for third time ( Reuters ) ( Endpoints...
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    Experts Pitch FDA on Policies to Improve Drug Development

    The US Food and Drug Administration (FDA) on Thursday heard from more than two dozen stakeholders on opportunities for the agency to promote more effective drug development programs at a public workshop at its headquarters in Silver Spring, Maryland.   “Effective drug development programs leverage the best available scientific knowledge to characterize the benefits and risks of a potential product and generate the data necessary to support product approval,” FDA says, ...
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    Recon: FDA Panel Warns No Adequate Replacement for Ethylene Oxide; Cardinal Health Wins $2.25B DoD Medical Supplies Contract

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Ethylene oxide plant closures put US on 'cusp of a major medical logistical failure' ( MedtechDive ) AdvaMed Statement on EtO Air Testing by EPA ( AdvaMed ) ( EPA v) Sarepta Therapeutics CEO playing nice with FDA over rejection of Duchenne drug ( STAT ) ( Fierce ) House Speaker Nancy Pelosi pushes vote on sweeping drug-pricing bill to December ( CNBC ) Senate...
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    Recon: J&J Submits Ebola Vaccine for EU Review; First Rituxan Biosimilar to Launch in US at 10% Discount

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US Sues Gilead Over HIV Drug Patents ( Focus ) ( NYTimes ) ( STAT ) ( Endpoints ) ( Law360 -$) George Church startup eGenesis rakes $100M for CRISPR pig organ transplants ( Endpoints ) ( Press ) Purdue Opioid Suits Put On Hold Until April ( Law360 -$) ( Reuters ) Teva puts further $468m aside for opioid-related settlements ( Financial Times ) How the FDA & EP...
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    FDA Warns Chinese Drugmaker Over GMP, Data Integrity Violations

    The US Food and Drug Administration (FDA) last month warned Chinese drugmaker Bingbing Pharmaceutical for good manufacturing practice (GMP) and data integrity issues, some of which stem from the company losing records after moving to a new facility.   The warning letter, which follows a four-day inspection of the company’s Hubei facility last May, details four violations related to record keeping, ingredient testing, quality control and complaint handling.   Accord...