• ReconRecon

    Recon: Democrats Push Back Against 10-Year Biologic Exclusivity in Nafta Rewrite; Snapchat Looks to Woo Pharma Advertisers

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Snap to drug advertisers: We’re the friendlier social network ( CNBC ) Drug Company Protections Are Latest Stumbling Block for Nafta Rewrite ( NYTimes ) ( Fierce ) House Democrats request Purdue opioid documents, focusing on the role of the Sacklers ( STAT ) J&J to record $700 million charge related to abandoned drug program ( Reuters ) ( Endpoints ) Massive ...
  • Regulatory NewsRegulatory News

    Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals

    Nonprofit advocacy group Public Citizen on Thursday filed a citizen petition calling for the US Food and Drug Administration (FDA) to impose a moratorium on approving new or reformulated opioids until the agency implements recommendations from a 2017 report by the National Academies of Science, Engineering and Medicine.   The petition is undersigned by Raeford Brown, the chair of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee who has spoken out again...
  • ReconRecon

    Recon: Biogen, Eisai Scrap Two Late-Stage Alzheimer’s Studies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen scraps Alzheimer drug trials, wiping $17 billion off its market value ( Reuters ) ( WSJ ) ( Endpoints ) CRISPR is ascending again, after scientists find ‘elegant’ fix for cancer worry ( STAT ) Roche sues US executives in fight over diabetes test strips ( Reuters ) ( Forbes ) Feng Zhang, heavyweight collaborators unveil latest CRISPR upstart — a diagnost...
  • Regulatory NewsRegulatory News

    EMA Follows FDA Warning on Xeljanz Blood Clot Risks

    The European Medicines Agency (EMA) on Wednesday warned patients and healthcare professionals against exceeding the recommended dose of Pfizer’s rheumatoid arthritis (RA) drug Xeljanz (tofacitinib) due to an increased risk of blood clots forming in the lungs.   EMA’s warning comes less than a month after the US Food and Drug Administration (FDA) issued a similar warning after identifying the risk during an ongoing postmarketing safety study for the drug. In the lat...
  • ReconRecon

    Recon: Pfizer Buys Stake in French Gene Therapy Developer Vivet

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Flagship Pioneering raises $824 million in venture capital round, its most ever ( STAT ) Julie Dohm, FDA’s top compounding official, set to leave agency ( STAT ) Their tissue turns to bone. Their joints freeze in place. And, finally, their hopes for treatment may be realized ( STAT ) J&J and Sientra get FDA warning letters over breast implants ( Focus ) ( Reut...
  • Regulatory NewsRegulatory News

    WHO Panel Calls for Global Gene Editing Registry

    The World Health Organization’s (WHO) newly-formed advisory panel on human genome editing is calling for the creation of a central registry for all human genome editing studies following a two-day meeting that concluded in Geneva on Tuesday.   WHO established the panel in December following reports that Chinese scientist He Jiankui had modified the genomes of a pair of twin girls to make them resistant to HIV infection. Jiankui’s claims prompted swift international b...
  • ReconRecon

    Recon: FDA Places Partial Hold on Trials for AbbVie’s Venclexta

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA puts partial hold on clinical trials of AbbVie's cancer drug ( Reuters ) ( Endpoints ) ( Press ) A drug pricing mystery: Who’s behind all the outrage over rebates? ( STAT ) The astounding 19-year journey to a sea change for heart patients ( STAT ) Ohio accuses UnitedHealth's OptumRx of drug overcharges in lawsuit ( Reuters ) Efforts to import drugs from C...
  • Regulatory NewsRegulatory News

    CDRH to Review Materials Used in Medical Devices

    Following recent high-profile safety issues related to materials used in implantable and insertable medical devices, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren on Friday announced plans to improve the agency’s approach to evaluating material safety and biocompatibility.   “Modernizing the regulatory framework pertaining to the FDA’s review of medical device materials requi...
  • ReconRecon

    Recon: Apple Watch Identifies Irregular Heart Beat in Large Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Apple Watch detects irregular heart beat in large US study ( Reuters ) ( STAT ) The policy initiatives Scott Gottlieb championed at the FDA will remain after he departs ( STAT ) Amarin’s Vascepa prevents second and third heart attacks in analysis, fueling debate ( STAT ) ( Endpoints ) ( Reuters ) Going Generic: Big Brands Poised To Lose Marketing Exclusivity I...
  • ExplainersExplainers
    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 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 18 March 2019 to include: Biohaven Pharmaceutical Holding Company has purchased...
  • ReconRecon

    Recon: EC Approves Roche’s MabThera for Rare Autoimmune Indication

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senator asks two pharma CEOs to clarify discrepancies in recent testimony about drug samples ( STAT ) The Family That Profited From the Opioid Crisis ( NYTimes ) Alex Azar's confusing claim on Medicaid work requirements ( Politico ) Grassley on the President's 2020 Budget W/ HHS Sec. Azar ( Senate Finance ) An ICU staple has exponentially spiked in price. Can...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on the nonclinical studies drugmakers should conduct when developing products to treat severely debilitating or life-threatening hematologic disorders (SDLTHDs).   FDA classifies SDLTHDs as hematologic conditions that cause shorter life expectancy or greatly diminished quality of life even with available treatments.   FDA notes that the guidance does not apply to hematologic cancers and covers...