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    House E&C Questions Insulin Manufacturers

    The House Committee on Energy and Commerce (E&C) on Wednesday sent letters to the three insulin manufacturers serving the US: Eli Lilly, Novo Nordisk and Sanofi, seeking more information on the root causes of the rising cost of insulin. First discovered more than 100 years ago, average insulin prices nearly tripled between 2002 and 2013 and then nearly doubled between 2012 and 2016, with patients bearing the brunt of those price spikes. Now, just a day after two moth...
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    Marketing Status Notifications: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Wednesday unveiled new draft guidance to help sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what information they’re now required to share with FDA on the marketing status of their brand and generic drugs. Thanks to the FDA Reauthorization Act of 2017 , drugmakers are required to provide additional information regarding the marketing status of approved drug products, includ...
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    US, EU Pledge to Cooperate on UDI Specifications

    The US and EU will cooperate to ensure alignment of electronic database specifications for Unique Device Identifiers (UDIs) and will develop a bilateral test of compatibility of respective UDI databases, according to the interim report on the work of the US-EU Executive Working Group (EWG) on trade. The report said such cooperative work will be in concert with ongoing efforts from the International Medical Device Regulators Forum (IMDRF), which consulted on UDIs in 20...
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    House, Senate Hearings Address Pharmaceutical Prices

    The House Oversight Committee and the Senate Finance Committee on Tuesday held hearings addressing the rising cost of prescription drugs, with both committees featuring mothers of insulin-dependent children, including one whose daughter died because of rationing due to the cost of insulin. Senate Finance Chair Chuck Grassley (R-IA) and others stressed the need for an investigation into the rising cost of insulin. “We need to continue to have a strong research engine ...
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    European Commission Updates Q&A on Safety Features for Medicinal Products

    The European Commission recently released an updated document setting out nine new and one revised frequently asked questions and answers on the implementation of the rules on the safety features for medicinal products for human use. Building off a previous update in November , five of the new questions deal with general issues, like whether medicinal products can carry more than one batch number, or whether during the transitional period manufacturers located in the E...
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    Gottlieb Lays Out Real World Evidence Priorities for 2019

    Stressing the need for speed and efficiency, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Monday offered a look at FDA’s plans around real-world data (RWD) and real-world evidence (RWE) in 2019. The speech at the Bipartisan Policy Center built off a framework, released in December , that sought to begin the conversation on how RWD and RWE can support changes to labeling, including adding or modifying an indication, changes in dose, dose regimen ...
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    New Deal to Reopen Federal Government Until Feb. 15

    The US Food and Drug Administration (FDA) and other parts of the federal government will reopen for a few weeks while border security is ironed out, according to a deal President Donald Trump announced Friday. Senate Minority Leader Chuck Schumer (D-NY) said the deal would pass both the Senate and the House on Friday and re-open the government through 15 February. And the government will be back open on Monday. Senate Majority Leader Mitch McConnell (R-KY) said in a ...
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    Biopharma Companies Explain Brexit Preparations

    Gearing up for the prospect of the UK departing from the EU without a deal, biopharma companies are preparing with different precautions costing upward of $100 million per company. Novartis on Friday offered its take on the latest preparations, raising alarms about the implications. “Following Parliament’s vote, the risk of UK exiting the EU without a deal is increased and this will be hugely impactful for patients, particularly around the supply and safety of medici...
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    FDA on Lilly's Lartruvo: No New Patients Outside an Investigational Study

    Just a day after a similar European Medicines Agency (EMA) warning, the US Food and Drug Administration (FDA) late Thursday recommended that Eli Lilly’s Lartruvo (olaratumab) should not be initiated in new patients outside of an investigational study. Both agencies noted how a recently completed Phase 3 study did not confirm the clinical benefit of Lartruvo. “Specifically, the study did not meet the primary endpoint of improvement in overall survival for Lartruvo and do...
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    UK Looks to Ensure Pharma Submissions Can Continue Under No Deal Brexit

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to ensure that if the UK leaves the EU without a deal, pharmaceutical companies can continue to submit regulatory and notification information to the UK. “If the UK leaves the EU with no deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks. Submissions related to human medicines would need to be submitted directly to the MHRA,” the agency said. ...
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    Assessing the Effectiveness of REMS: FDA Drafts Two New Guidances

    The US Food and Drug Administration (FDA) on Thursday released two new draft guidance documents aiming to help improve the agency’s ability to ensure that Risk Evaluation and Mitigation Strategies (REMS) put in place for certain drugs and biologics are working properly. The guidances provide industry with a framework to develop a REMS Assessment Plan to better develop a REMS program and improve the quality of the information used to assess the effectiveness of it, and t...
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    PDUFA Funds Likely to Run Out in February

    As the Senate preps for votes to reopen the government on Thursday, the situation at the US Food and Drug Administration (FDA) is becoming increasingly strained. At an all-staff meeting for employees of the centers for drugs and biologics on Tuesday, Commissioner Scott Gottlieb announced that Prescription Drug User Fee Act (PDUFA) funding is likely to run out by 17 February (he’d previously said it would run out by the beginning of February), although the agency may f...