• ReconRecon

    Recon: Astellas to Buy Gene Therapy Developer Audentes for $3B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate Committee Advances Nomination of Hahn as FDA Commissioner ( Focus ) US Considers Easing Drug Protections to Break Logjam Over Trade Pact ( WSJ ) ( Reuters ) Medical Device Failures Brought To Light Now Bolster Lawsuits And Research ( KHN ) Merck Cyberattack’s $1.3 Billion Question: Was It an Act of War? ( Bloomberg ) States fight bonus pay for CEO of O...
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    FDA Finalizes Guidance on Adaptive Trial Designs

    The US Food and Drug Administration (FDA) last week finalized guidance on adaptive clinical trial designs for drugs and biologics.   The 33-page guidance, which finalizes a draft version released for comment in September 2018 and replaces an earlier guidance from 2010, sets out FDA’s recommendations on adaptive trial design principles and the information FDA will review from adaptive studies submitted as part of investigational new drug applications (INDs), new drug ...
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    Recon: Drugmakers Cut Prices to Make China’s Reimbursement List; Baxter Buys Sanofi’s Seprafilm for $350M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Baxter picks up Sanofi's Seprafilm adhesion barrier for $350M ( MedtechDive ) ( Endpoints ) Lexicon Pharma shares plummet after FDA denies appeal against drug rejection ( Reuters ) Incyte claims FDA priority review for bile duct cancer drug ( PMLive ) AstraZeneca's Imfinzi gets speedy FDA review for small cell lung cancer ( Reuters ) ( PMLive ) Merck’s Keytru...
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    ICH Updates After Singapore Assembly Meeting

    The International Council for Harmonisation (ICH) on Wednesday provided an update on some of the milestones achieved following the ICH Assembly meeting in Singapore earlier this month.   Guidelines   During the meeting, the ICH Assembly adopted several guidelines for Step 4 of the ICH process, while several working groups advanced early stage efforts toward the development of new topics and upcoming revisions to existing guidelines.   The newly adopted guidelin...
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    Recon: Pfizer, Novartis Lead Global Gene Therapy Manufacturing Investment; US Prosecutors Open Opioid Criminal Probe

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen will offer discounts to a health plan if patients say its multiple sclerosis drugs don’t work ( STAT ) Judge partly vacates convictions of opioid maker Insys' founder, executives ( Reuters ) SEC charges ex-MiMedx execs with defrauding investors ( Fierce ) ( Endpoints ) US prosecutors open criminal probe of opioid makers, distributors ( Reuters ) ( WSJ )...
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    EMA to Implement Ombudsman’s Recommendations on Avoiding Bias

    In a letter to the EU ombudsman Emily O’Reilly last week, the European Medicines Agency (EMA) said it will adopt her recommendations to avoid the perception of bias in marketing authorization assessments.   The letter follows an inquiry by the ombudsman that began in 2017 over concerns that interactions between drugmakers and EMA during the pre-submission phase could influence EMA’s decision to recommend an application for authorization.   Initially, EMA pushed bac...
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    Recon: Japan’s Asahi Kasei to Buy Veloxis for $1.3B; Spanish Antitrust Regulator Probes Merck

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How a billionaire couple greased the skids for Nancy Pelosi’s drug pricing bill ( STAT ) FDA approves Global Blood Therapeutics sickle cell disease drug ( Reuters ) ( STAT ) ( FDA ) Pharma execs tell researchers that multiple sclerosis drug pricing is based on competition, not R&D costs ( STAT ) FDA approves J&J spinout's device for kids with recurring ear inf...
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    Upton and DeGette Begin Work on Cures Act Reprise

    Three years after the passage of the 21 st Century Cures Act , Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) are starting work on a version 2.0 of the bill with a focus on access to new medicines, digital health and furthering the use of real-world evidence (RWE) by the US Food and Drug Administration (FDA).   In a two-page call to action paper, DeGette and Upton ask for input on how to address those and other healthcare challenges in a future legislative package ...
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    Recon: Novartis to Buy Medicines Company for $9.7B; Blackstone, Ferring Announce $570M Gene Therapy Venture

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis to Buy the Medicines Company for $9.7 Billion ( AP ) ( Financial Times ) ( WSJ ) ( STAT ) ( Reuters ) The big drug hunters: Novartis’ $28B-plus deal spree makes Vas Narasimhan one of the top dealmakers of our time ( Endpoints ) Adamis shares slump as FDA declines to approve opioid overdose treatment  ( Reuters ) ( Press ) FDA approves Aquestive's ALS ...
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    Stem Cells: FDA Continues Enforcement Effort With Letter to Florida Supplier

    As part of its ongoing enforcement efforts against companies marketing unapproved stem cell products, the US Food and Drug Administration (FDA) on Wednesday sent an untitled letter to Florida-based manufacturer RichSource Stem Cells over unsubstantiated claims for its Richgen allograft product.   The letter comes months after FDA announced it would step up its enforcement efforts against rogue stem cell clinics and manufacturers for marketing unproven stem cell thera...
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    Recon: FDA Approves SK Life Science’s Seizure Drug Xcopri; Rewrite Coming for Grassley-Wyden Drug Pricing Bill

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Changes coming to Grassley-Wyden drug bill ( Politico ) ( Senate Finance ) FDA approves new epilepsy therapy, a first for Korea's SK Life Science ( BioPharmaDive ) ( FDA ) ( Press ) AstraZeneca wins FDA approval for Calquence in chronic lymphoma ( PMLive ) ( Endpoints ) ( Press ) ViiV inks bNAb deal with National Institutes of Health ( PharmaTimes ) ( Endpoint...
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    Contamination Potential Leads UK to Fifth Recall of Ranitidine Drugs

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday announced the fifth recent recall of the heartburn medicine ranitidine due to possible contamination with the carcinogen N- nitrosodimethylamine (NDMA).   The recall, which affects 13 over-the-counter (OTC) ranitidine medicines marketed by four different companies, follows four previous recalls in October and November and comes as international regulators including the US Food and Drug Admi...