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  • February 6, 2023

    Bayer, Serono to Limit Drug Price Discounts

    Several Bayer products will remain exempt from the new policy, while Serono’s 340B change is limited to two drugs.
  • February 6, 2023

    Medicago to Shut Down Despite COVID-19 Vaccine Approval

    The company had planned to develop vaccines for several other conditions, including seasonal flu, rotavirus and norovirus infections.
  • February 6, 2023

    FDA Warns That Energy Supplement Contains Active Cialis Ingredient

    The product is sold on Amazon.com and “possibly in some retail stores,” the agency said.
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Research and Development

  • January 30, 2023

    FDA Lifts Clinical Hold on Inhibikase Candidate for Parkinson’s Disease

  • January 30, 2023

    Dozens of Pediatric Trials Failed to Properly Report Results, Study Finds

  • January 27, 2023

    FDA Launches Research Pilot to Improve Biosimilar Development Cost and Timeline

  • January 26, 2023

    Keytruda Flops Again in Prostate Cancer But Wins in Biliary Cancer

  • January 23, 2023

    Janssen Phase 3 HIV Vaccine Study Halted Due to Lack of Efficacy

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Submissions and Approvals

  • February 6, 2023

    Two Years After FDA Rejection, Mesoblast Resubmits BLA for Remestemcel-L

  • February 3, 2023

    FDA Approves GSK’s Oral Drug for Chronic Kidney Disease-Related Anemia

  • February 2, 2023

    FDA Pushes Back Decision Date on Argenx BLA to June

  • February 1, 2023

    EU Expands Dupixent’s Authorization to Include Eosinophilic Esophagitis

  • February 1, 2023

    Amgen Launches Long-Approved Humira Biosimilar Amjevita

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  • International standards for clinical trials 500

    International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

    $249.00
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    FDA’s Remote Assessments v. Remote Interactive Evaluations: Do You Really Know the Difference? – Webinar Recording/Transcript

    $287.00
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    The Inextricable Link Between Data Integrity and Quality Culture – Webinar Recording/Transcript

    $287.00
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Events

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

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