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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...
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    Recon: AZ Backs $1B China Biotech Fund; Confirmation Hearing for FDA Commissioner set for 20 November

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate HELP Committee to Hold Confirmation Hearing for Nominee Hahn on 20 November ( HELP ) CRISPR Takes Its First Steps in Editing Genes to Fight Cancer ( NYTimes ) ( AP ) ( NPR ) White House and Pelosi part ways on relief for drug prices ( AP ) ASH preview: Celgene, Bluebird, and J&J out with early but telling data in blood cancer ( STAT ) Mallinckrodt rece...
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    Regulatory NewsRegulatory News

    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 6 November 2019 to include: How Jazz Pharmaceuticals plans to use the PR...
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    Senators ‘Disappointed’ by FDA’s Pivot on Progressive Approvals for Devices

    In a letter to top US Food and Drug Administration (FDA) officials on Monday, Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) say they are concerned about the agency’s renewed interest in a progressive approval system for certain medical devices.   The letter, addressed to Acting FDA Commissioner Brett Giroir and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren, questions the agency’s about-face on progressive approvals for devices after ...
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    Recon: Takeda Licenses MD Anderson CAR NK Therapies; FDA Offered Divergent Forecasts on Fecal Transplants

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Concerns raised about Giroir at FDA ( Politico ) FDA Approves 24th Biosimilar, 3rd for Neulasta  ( Focus ) ( Reuters ) ( Endpoints ) 1 in 2 seriously ill Medicare enrollees struggles with bills ( AP ) ( Axios ) A New Approach to Gene Therapy—Now In Dogs, Maybe Later In Humans ( WSJ ) Obscure Model Puts a Price on Good Health—and Drives Down Drug Costs ( WSJ )...
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    ICH Updates: What to Expect Through 2020

    At a joint public consultation in Ottawa on Monday, officials from Health Canada and the US Food and Drug Administration (FDA) gave an overview of the progress made on more than two dozen International Council for Harmonisation (ICH) guidelines ahead of the upcoming ICH Assembly meeting in Singapore later this month.   The consultation comes roughly six months after FDA hosted the previous joint consultation with Health Canada in advance of the ICH Assembly’s meeting...
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    Recon: Stryker to Buy Wright Medical for $4B; China Conditionally Approves First Domestically Developed Alzheimer’s Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Stryker boosts bone implants with $4 billion Wright Medical buyout ( Reuters ) ( Financial Times ) Halozyme’s lead drug fails; company will cut 55% of workforce in bid for profitability ( STAT ) ( Endpoints ) Trump Nominates Hahn to be FDA Commissioner ( Focus ) FDA Keeps Brand-Name Drugs on a Fast Path to Market ― Despite Manufacturing Concerns ( The Daily Be...
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    Recon: Amgen Takes 20.5% Stake in BeiGene; Novartis Cosentyx Fails to Top Humira in Head-to-Head Trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA is modernizing its technology to prepare for a new wave of therapies ( Politico ) Google takes on wearables giants with $2.1 billion Fitbit deal ( Reuters ) ( WSJ ) Realizing the Dream of Molecularly Targeted Therapies for Cystic Fibrosis ( NEJM ) ( NIH ) ( NYTimes ) AbbVie Earnings, Revenue Beat in Q3 ( Yahoo ) ( Press ) AbbVie says multiple parties vyin...
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    Chronic Hepatitis D: FDA Drafts Drug Development Guidance

    With no drugs currently approved to treat chronic hepatitis D (HDV), the US Food and Drug Administration (FDA) on Thursday issued draft guidance laying out recommendations for developing new treatments.   In an overview of current chronic hepatitis D management, authors Patrizia Farci, chief of the Hepatic Pathogenesis Section of the Laboratory of Infectious Diseases at the National Institute of Allergy and Infectious Diseases and Grazia Niro, staff clinician at IRCCS ...