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    FDA, USP Clash Over Biologics Monographs

    While the US Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) work closely with one another on many issues, the two are at odds over a proposal that would exclude biological products, including biosimilars, from requirements to adhere to USP monographs.   The proposal, which is included in President Donald Trump’s FY2020 budget request and a discussion draft circulated by the Senate Health, Education, Labor and Pensions (HELP) committee l...
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    Recon: France’s Dassault to Buy Medidata for $5.8B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Move Over, Martin Shkreli: This Pharma Exec Is Accused Of Fixing Prices On 107 Drugs ( Forbes ) Daily HIV Prevention Pill Urged for Healthy People at Risk ( AP ) ( CNBC ) J&J ‘Did Everything’ to Push Opioids, Oklahoma Witness Says ( Bloomberg ) Judge holds up Teva's $85M opioid settlement, sinking shares back to pre-2000 levels ( Fierce ) ( Law360 -$) Acciden...
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    FDA Warns Taiwan Drugmaker Over GMP Violations

    The US Food and Drug Administration (FDA) last month warned Taipei, Taiwan-based drugmaker Vida International over good manufacturing practice (GMP) violations following an inspection of the company’s Taoyuan City facility last December.   As a result of the observations made during the inspection, FDA placed Vida on import alert in March.   In the warning letter, FDA cites Vida for failing to conduct necessary batch testing for one of its products before release. ...
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    US-EU Mutual Recognition Pact Adds Luxembourg, Netherlands

    The European Medicines Agency (EMA) on Tuesday announced that Luxembourg and the Netherlands have joined the mutual recognition agreement for good manufacturing practice (GMP) inspections between the US Food and Drug Administration (FDA) and EU member states.   The announcement comes six weeks after Bulgaria and Cyprus joined the agreement. The agreement, which began in 2017, has expanded multiple times to include additional EU member states as FDA confirms the inspe...
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    Recon: Merck’s Keytruda Picks up Two New Indications for Head and Neck Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck's Keytruda wins FDA approval to treat head & neck cancer ( Reuters ) ( Endpoints ) ( Press ) ( FDA ) Startup offering free DNA sequencing signs first pharma sponsor ( STAT ) How pharma could benefit from one of Congress’ signature drug pricing ideas ( STAT ) Jacobus prices its rare disease drug at half of what Catalyst charges, but will doctors prescribe...
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    Health Canada Notice Details When Off-Label Use is not Considered Investigational in a Clinical Trial

    Health Canada last week issued a notice clarifying the circumstances in which the off-label use of an authorized drug in a clinical trial would not be considered investigational.   The agency says the notice, which went into effect on 5 June, will “serve as interim interpretive guidance until amendments can be made to the Food and Drug Regulations.”   Health Canada says its previous interpretation of the regulations governing clinical trials led it to require drugs...
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    FDA Moves Compounding Program to Office of Compliance

    In an email to staff distributed Monday, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said the agency plans to “institutionalize” its compounding regulatory program within the center’s Office of Compliance.   In the aftermath of the 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least 60 deaths, FDA created an agency lead for compounding within C...
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    Recon: Merck to Acquire Tilos for $773; Roche Gets Accelerated Approval for Lymphoma Drug Polivy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck to buy Tilos Therapeutics for up to $773 million ( Reuters ) ( STAT ) ( Endpoints ) ( Press )  Merck’s Baby Biotech Splurge Won’t Fix Its Reliance on Keytruda ( Bloomberg ) In a boost to Rituxan franchise, Roche nabs quick approval for Polivy ( Endpoints ) ( Press ) ( FDA ) Co-owner, ex-employee of pharmacy in U.S. meningitis outbreak acquitted ( Reuters...
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    Recon: Sanofi Names Novartis’ Hudson as CEO; FDA Panel Backs TB Alliance’s TB Treatment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Vertex Pharmaceuticals expands into Duchenne gene therapy with new deals ( Reuters ) ( PMLive ) ( Endpoints ) ( Fierce ) FDA advisory panel recommends approval of TB Alliance's tuberculosis treatment ( Reuters ) In a surprise, Hans Bishop takes over as CEO of Grail, the liquid biopsy startup ( STAT ) ( Endpoints ) AIDS groups criticize Express Scripts for excl...
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    FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance aimed at increasing diversity in clinical trial populations as part of its efforts to encourage drugmakers to enroll populations that more closely reflect the populations that will take the drugs in the real world.   “This guidance recommends approaches that sponsors of clinical trials to support a new drug application [NDA] or a biologics license application [BLA] can take to broaden eligibi...
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    Recon: Insys, Mallinckrodt Settle Opioid Cases; Takeda Drops Late-Stage Amyloidosis Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Third Rock raises $770 million in new funding round ( STAT ) ( Endpoints ) ( Fierce ) Liberals fight their own party over drug prices ( Politico ) ( The Hill ) Insys to pay $225 million, plead guilty in US over opioid kickbacks ( Reuters ) ( NYTimes ) ( STAT ) ( Endpoints ) ( Law360 -$) ( DoJ ) Mallinckrodt to settle U.S. drug marketing probe, fight kickback c...
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    Industry Groups Debate FDA’s Approach to Interchangeable Insulin Products

    Branded and generic drugs industry groups are sparring over the US Food and Drug Administration’s (FDA) approach to regulating biosimilar and interchangeable insulin products following a public meeting on the matter last month.   In March 2020, FDA will begin transitioning certain biological products – such as insulin, insulin analogs and human growth hormone – that were initially approved under new drug applications (NDAs) to be deemed to be licensed under section 3...