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    EMA’s CHMP Recommends Six Medicines for Approval

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced the recommendation of six medicines for approval, including two orphan medicines, as well as three extensions of indications and a new vice-chair.   Of the six medicines, at its October meeting, CHMP recommended granting an authorization for Shire’s Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of heredi...
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    European Commission Offers Guidance on UDIs

    Building off guidance released in March, the European Commission this month unveiled five new guidance documents on the use of unique device identifiers (UDIs).   The guidances deal with UDIs for systems and procedure packs, definitions and descriptions of formats of the UDI core elements for systems and procedure packs, UDI assignment to medical device software, clarification of UDI responsibilities in relation to Article 16, and provisional considerations regarding l...
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    Manufacturers Not Ready for November DSCSA Deadline, Study Finds

    A new study found that pharmaceutical manufacturers are woefully behind in meeting a 27 November deadline, as nearly 80% of pharmaceutical packages still do not have a readable barcode with all four required data elements necessary to meet the requirements of the Drug Supply Chain Security Act (DSCSA).   The study, from AmerisourceBergen, Cardinal Health and McKesson Pharmaceutical, which represent about 90% of pharmaceutical distribution in the US, examined package ...
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    FDA Looks to Harmonize Generic Drug Scientific and Technical Standards via ICH

    The US Food and Drug Administration (FDA) revealed Thursday that it’s offering a proposal to the International Council on Harmonisation (ICH) to better harmonize scientific and technical standards for generic drugs. The plan is to allow generic drug developers to implement a single global drug development program, with common elements of applications to file, to allow for simultaneous approvals in multiple markets. “This would make it easier for developers that would...
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    OPDP Sends Untitled Letter to Eisai for Sales Rep’s Off-Label Comments

    The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) on Wednesday released an untitled letter sent earlier this month to Eisai for a sales representative’s comments on off-label uses for Fycompa (perampanel).   According to a complaint made to OPDP, the Eisai sales representative “made statements that provide evidence that Fycompa is intended for new uses for which it lacks approval, and for which its labeling does not provide adequate dir...
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    Fall Agenda for FDA Rulemakings: See What’s Coming for Drugs, Medical Devices

    The fall agenda for proposed and final rulemakings for the US Food and Drug Administration (FDA) was released on Wednesday and includes dozens of proposed and finalized rulemakings that will affect drug and device companies.   Below is a rundown of the rulemakings with brief descriptions of what’s in FDA’s plans for the near future and what drugmakers and device firms should be ready for, in addition to those that are being withdrawn.   October and November   O...
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    FDA’s OPDP Warns MannKind for Facebook Post

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) earlier this month sent a warning letter to MannKind for a Facebook post that makes false or misleading claims about the risks associated with the company’s inhaled insulin, known as Afrezza.   “These violations are especially concerning from a public health perspective because Afrezza is a drug with multiple serious, potentially life-threatening risks, including a BOXED WARNING fo...
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    CBER Sends Untitled Letter to Marketer of Unapproved Allergy Spray

    The US Food and Drug Administration’s (FDA) Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research (CBER) sent an untitled letter to the owner of two websites purporting to sell allergy treatments that have not been approved.   The company Telogenes, LLC boasts that its product, known as Ollereg, “contains FDA-approved allergens used off label for oral immunotherapy,” among other claims, but FDA raised concerns.   “Based on t...
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    Presenting Risk and Efficacy Info in DTC Ads: FDA Drafts Guidance

    Just a day after the Centers for Medicare and Medicaid Services proposed requiring drug prices in television ads, the US Food and Drug Administration (FDA) is offering industry guidance on how to present efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertising. The 10-page draft guidance outlines FDA’s recommendations for how companies that include quantitative efficacy or risk information in DTC promotional materials can make the l...
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    CMS Proposes Requiring WAC Prices to be Included in Pharma TV Ads

    The Centers for Medicare and Medicaid Services (CMS) late Monday unveiled a new proposed rule that would require companies to include wholesale acquisition costs (WAC) in direct-to-consumer television advertisements. CMS claimed in its proposal that the purpose of this rule is to reduce drug and biologic prices, though some experts have questioned whether the move has enough behind it to actually lower prices, and others questioned if the rulemaking would stand up to a ...
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    ICER Plots Early Scientific Advice Program for Biopharma

    The Institute for Clinical and Economic Review (ICER) is looking to help the biopharma industry with earlier reviews of clinical work, adding to their current independent evaluations of the clinical and economic value of prescription drugs, medical tests and other health innovations.   “For some time, ICER has been receiving requests from life sciences companies to help them rethink clinical trial design, so that the trials more adequately measure the types of outcomes...
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    Hematologic Malignancies: FDA Offers Draft Guidance on Use of MRD

    The US Food and Drug Administration (FDA) on Monday released new draft guidance to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials or to support marketing approval of drugs and biologics treating specific hematologic malignancies. The 18-page guidance features sections on developing MRD as a biomarker for regulatory use, including meta-analyses for validation of MRD as a surrogate endpoint, technology considerations and dis...