• Regulatory NewsRegulatory News

    FDA Warns Three Drugmakers, Diagnostic Company

    The US Food and Drug Administration (FDA) recently warned three drugmakers for good manufacturing practice (GMP) violations and a California-based diagnostic maker for distributing reagents without submitting premarket notification or obtaining premarket approval for the tests.   Torrent Pharma   In its warning letter to Torrent Pharma, FDA cites the company for sanitary deficiencies related to its water system and for failing to thoroughly investigate failed test ...
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    Recon: CRISPR, Vertex Therapy Shows Early Benefit in First Two Patients; Donors Pledge $2.6B for Polio Eradication

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US First CRISPR treatment for blood diseases shows early benefits in two patients ( STAT ) ( Endpoints ) ( Press ) Novo Nordisk’s parent company to launch research incubator in Boston ( STAT ) ( Xconomy ) Inside Purdue Pharma’s Media Playbook: How It Planted the Opioid “Anti-Story” ( ProPublica ) Amarin releases interim EVAPORATE data — and mineral oil makes anot...
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    FDA Approves Contact that Slows Nearsightedness Progression

    The US Food and Drug Administration (FDA) on Friday granted premarket approval (PMA) to CooperVision’s MiSight contact lens to slow the progression of myopia, commonly known as nearsightedness, in children ages 8-12.   This is the first FDA-approved product to “slow the progression of myopia in children, which ultimately could mean a reduced risk of developing other eye problems,” said Malvina Eydelman, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT...
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    Recon: Recipharm to Buy Consort Medical for £505M; FTC Approves BMS-Celgene Merger

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US BMS wins antitrust approval to buy Celgene, must divest psoriasis drug ( Reuters ) ( PMLive ) ( FTC ) Novartis sickle-cell drug gets FDA approval  ( Reuters ) ( Endpoints ) ( Fierce ) ( FDA ) ( Press ) Trump says US states will be able to buy prescription drugs abroad ( Reuters ) FDA nominee to face questions on issues from vaping to salmon ( Roll Call ) Okla...
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    GAO: Drugmakers Have Mixed Views on FDA, FTC REMS Actions

    A report from the Government Accountability Office (GAO) released Thursday finds that generic and branded drugmakers are split over the US Food and Drug Administration (FDA) and Federal Trade Commission’s actions to improve generic drugmakers’ access to reference drug samples when the drugs are subject to a risk evaluation and mitigation strategy (REMS).   In 2017, former FDA Commissioner Scott Gottlieb famously told drugmakers to “end the shenanigans” that inhibit g...
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    FDA Finalizes Smallpox Drug Development Guidance

    The US Food and Drug Administration (FDA) on Friday finalized guidance on developing drugs to treat smallpox, clarifying aspects of a revised draft guidance released last year.   Just days after the revised draft guidance was released, FDA in July 2018 approved the first drug indicated to treat smallpox, Siga Technologies’ TPOXX (tecovirimat), which won the company a priority review voucher (PRV). In September the agency approved the first live, non-replicating sm...
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    Recon: Roche Buys Promedior for up to $1.4B; HHS Releases Hospital Price Transparency Rules

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Roche buys US drugmaker Promedior for up to $1.4 billion to get lung drug ( Reuters ) ( Endpoints ) China's BeiGene gets FDA approval for drug to treat rare form of lymphoma ( Reuters ) ( Financial Times ) ( Endpoints ) ( FDA ) After positive panel vote, Shionogi antibiotic scores US approval ( Endpoints ) ( Press ) ( FDA ) A drug maker courted controversy whe...
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    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...