News & Analysis as of

Pharmaceutical Industry Annual Reports

Smart & Biggar

CDA–AMC (formerly CADTH) announces several pilot projects, including Target Zero initiative

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CADTH is now known as Canada’s Drug Agency (CDA-AMC or CDA). Its mandate extends beyond CADTH’s mandate to include: improving the appropriate prescribing and use of medications; increasing pan-Canadian data collection and...more

Smart & Biggar

CADTH releases 2022-2023 Annual Report

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On August 3, 2023, the Canadian Agency for Drugs and Technologies in Health (CADTH) released its annual report. Highlights from 2022-2023 include...more

Smart & Biggar

2021 PMPRB Annual Report

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On November 21, 2022, the Minister of Health tabled the 2021 Annual Report of the Patented Medicine Prices Review Board (PMPRB). The Report includes information on the PMBRB’s regulatory activities, pharmaceutical sales and...more

Smart & Biggar

PMPRB releases 2020 Annual Report and April 2022 NEWSletter

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On March 30, 2022, the Minister of Health tabled the 2020 Annual Report of the Patented Medicine Prices Review Board (PMPRB). The 2020 Annual Report outlines the PMPRB’s mandate, structure and regulatory activities and...more

Alston & Bird

FDA to Develop National Standards for Drug Distributors – Medical Products Supply Chain Week in Review

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Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more

Smart & Biggar

Health Canada TPD, BRDD and NNHPD Annual Performance Reports released

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The Therapeutic Products Directorate (TPD), the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), and the Natural and Non-Prescription Health Products Directorate (NNHPD) have released their Drug Submission...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2020

Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more

Hogan Lovells

FDA proposes annual summary reporting requirements for Right to Try drug sponsors, manufacturers

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On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

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In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

Foley & Lardner LLP

The Era of Personalized Medicine Has Arrived - PMC’s Annual Progress and Outlook Report

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The Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: A Progress & Outlook Report” (Report) that monitors current successes and challenges in bringing personalized therapies to market....more

Goodwin

Biosimilar Updates: Epoetin, Rituximab, Adalimumab

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Over the past week or so, several biologic and biosimilar companies have issued their year-end earnings reports. Below are some highlights on the biosimilar front...more

Cooley LLP

Blog: CMS’ Annual Open Payments Report to Congress Highlights Some Key Areas to Watch

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The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more

Troutman Pepper

FTC Report Tallies Hatch-Waxman Settlements for FY2013

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On December 22, 2014, the Federal Trade Commission (FTC or the Commission) released an overview of pharmaceutical patent settlements filed with the Commission in Fiscal Year 2013 (October 1, 2012–September 30, 2013). The FTC...more

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