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    Edwards Lifesciences Recalls Devices After 3 Deaths Reported

    The US Food and Drug Administration (FDA) recently announced a Class I recall of more than 700 Edwards Lifesciences’ IntraClude Intra-Aortic Occlusion Devices after receiving 22 complaints related to balloon rupture or puncture, including three deaths. The device is used in patients undergoing cardiopulmonary bypass — a technique described by FDA as when “a machine temporarily takes over the function of the heart and lungs during surgery. When the IntraClude balloon is ...
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    FDA Eliminates REMS for HIV Drug Truvada and its Generics

    The US Food and Drug Administration (FDA) announced late Monday that it would eliminate the risk evaluation and mitigation strategy (REMS) for Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate) and its four approved generics, which reduce the risk of sexually acquired HIV. As part of the 2012 FDA approval of Truvada for HIV pre-exposure prophylaxis (PrEP), in combination with safe sex practices, the agency required manufacturers to provide training materials...
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    EC Offers Two New Guidance Documents on MDR/IVDR

    The European Commission (EC) on Monday released one new guidance on persons responsible for regulatory compliance under the Medical Device Regulation (MDR) and the in vitro Diagnostic Device Regulation (IVDR), and another guidance on the implant card required by MDR. Under Article 15 of MDR and IVDR, companies are required to have at least one employee responsible for regulatory compliance with a degree in law, medicine, pharmacy, engineering or another relevant scien...
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    FDA Drafts Two New Guidances on Drug Labeling

    The US Food and Drug Administration (FDA) on Monday released one draft guidance on the content and format of the “Drug Abuse and Dependence” section of labeling and another on the content and format of the Instructions for Use (IFU) of a medicine. For the 12-page draft guidance on the “Drug Abuse and Dependence” section, FDA says the section should be concisely and clearly written to summarize the product’s “abuse potential, signs and symptoms of withdrawal, and abuse-d...
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    CBER Plans Draft Guidance on ‘Sameness’ of Gene Therapies Under Orphan Drug Regulations

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has updated its list of 2019 guidance and added a new draft on interpreting “sameness” of gene therapy products under the orphan drug regulations. The new draft on sameness, under the category of Tissues and Advanced Therapies, is expected in addition to the finalization of six guidance documents on gene therapies released last July, final guidance from February on expedi...
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    EMA’s CHMP Rejects Another Drug Approved by US FDA

    The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday adopted a negative opinion for UCB Pharma’s osteoporosis treatment Evenity (romosozumab), which was approved by the US Food and Drug Administration (FDA) in April. CHMP said the rejection followed concerns that patients given Evenity had an increased risk of serious heart or circulatory system effects, such as heart attacks or strokes. “In addition, when all the data w...
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    House Committee Questions FDA on Foreign Drug Manufacturing Inspections

    As the US Food and Drug Administration (FDA) continues to recall contaminated blood pressure drugs made in foreign facilities, the House Energy & Commerce (E&C) Committee on Friday sent a letter to acting FDA Commissioner Ned Sharpless questioning the agency’s work overseas. “We remain concerned about whether FDA has the resources, policies, management practices, and authorities to oversee adequately foreign drug manufacturing,” Chairman Frank Pallone (D-NJ), Ranking Me...
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    Another Biosimilar Approval From FDA, Another Unknown Launch Date

    The US Food and Drug Administration (FDA) on Friday approved Pfizer’s Zirabev (bevacizumab-bvzr), the 21 st biosimilar in the US and the second for Roche’s cancer treatment Avastin (bevacizumab). But the launch date in the US for Zirabev, a treatment for five types of cancer, remains unknown, as does the launch date for its predecessor, Amgen’s Mvasi (bevacizumab-awwb), approved in September 2017. Similarly, two Enbrel (etanercept) biosimilars have been approved, the f...
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    Pfizer Appoints Gottlieb to Board of Directors

    Following in the tradition of recently departed US Food and Drug Administration (FDA) commissioners, Scott Gottlieb is joining the board of directors at Pfizer. In addition to his role on the Pfizer board, Gottlieb, an elected member of the National Academy of Medicine, is also resident fellow at the American Enterprise Institute and a partner at the venture capital firm New Enterprise Associates. Reactions to Gottlieb’s decision to join the Pfizer board ranged from ...
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    FDA Proposes New Rule on Allowing the Use of DMFs for Transitioning Biologics

    The US Food and Drug Administration (FDA) on Thursday proposed a new rule to allow certain biologics, originally approved under a new drug application (NDA), to continue relying on drug master files (DMFs) for certain information even after the NDA is deemed to be a license for a biological product on 23 March 2020. This so-called “deemed to be a license” transition next year, the details of which were explained in full last December, will mean that moving forward, fo...
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    FDA Drafts Guidance on Heart Failure Treatment Endpoints

    As heart failure afflicts 6.5 million in the US, the Food and Drug Administration (FDA) on Thursday released draft guidance on the agency’s current thinking on developing drugs to treat heart failure. While noting that there are no effective treatments for heart failure with preserved ejection fraction (HFpEF), which represents about 50% of heart failure cases, FDA says up front that the 7-page draft has two purposes: to make clear that an effect on symptoms or physical...
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    Senate Coalesces Around Series of Drug Pricing Bills With Little Impact on Pharma Companies

    The Senate Judiciary Committee on Thursday advanced four bills to the Senate floor, three of which were bipartisan, and all meant to lower the prices of prescription drugs. The four bills are part of a coordinated push in the Senate and include a larger bill that advanced Wednesday out of the Senate health committee and is expected to be taken up on the Senate floor before the end of July, and another bill that Sen. Chuck Grassley (R-IA) said he was likely to advance ...