LSL Web-Exclusive Content

  1. Medicare Negotiation And Competitive Licensing Act: An Ambitious Challenge To Biologic Patents
    5/21/2019

    In recent years there has been growing, bipartisan support to address the perceived high cost of biologic drugs. Indeed, recent estimates are that biologic drugs account for approximately 40 percent of all U.S. pharmaceutical sales and 70 percent of drug spending growth between 2010 and 2015.

  2. Patient-Focused Drug Development Under The 21st Century Cures Act
    5/21/2019

    More than two years have passed since the 21st Century Cures Act was signed into law in December 2016. According to the FDA, the Cures Act is designed to help accelerate medical product development and bring new innovation and advances to patients who need them faster and more efficiently.

  3. Gene Therapy: Commercial Challenges And Strategic Choices
    5/16/2019

    Innovation in gene therapy brings the potential for transforming patient care and obviating the need for chronic therapy through single-dose cures. Despite the potential long-term benefits of this new therapeutic modality, gene therapy companies face a number of underappreciated challenges.

  4. The China Biosimilars Market: Rise Of A Potential Powerhouse
    5/14/2019

    Since 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the US. How does the rise of the China biosimilars market fit this established picture?

  5. A High-Level Overview of the Proposed Rule To Align FDA’s QSR with ISO 13485
    5/13/2019

    The latest version of ISO 13485 already contains several requirements that do not exist in 21 CFR 820. In advance of the new proposed rule’s release, this article presents a summary of the potential changes’ impacts on medical device manufacturers once the proposed rule becomes final.

  6. How The Purple Book Continuity Act Could Challenge Biosimilars & The FDA
    5/7/2019

    On March 5, 2019, Representative Anna Eshoo (D-CA) introduced H.R. 1520, the “Purple Book Continuity Act of 2019.” The bill addresses the availability of information about approved biological products that may support the development of biosimilar products. It has five cosponsors in the House, drawn from both sides of the aisle, and was considered with five other bills by the House Energy and Commerce Committee on April 3, 2019. The Committee advanced the bill, along with five others, as a step toward addressing runaway drug pricing.

  7. Understanding The FDA’s Final Guidance On Manufacturing Site Changes
    4/22/2019

    The guidance looks at what constitutes a manufacturing site change, when a manufacturer should submit a PMA supplement, what documentation should be submitted to the FDA with a site change supplement, and more.

  8. A Technology Roadmap For Today’s Gene Therapy Manufacturing Challenges
    4/18/2019

    The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has published technology roadmaps addressing needs and gaps in three key product areas: gene therapy, antibody-dug conjugates, and vaccines. The roadmaps were developed with the collaborative input of industry, academic, and government experts. This article highlights technology opportunities for gene therapy manufacturing.

  9. Inside FDA's Proposed Program To Establish Voluntary Quality Standards
    4/17/2019

    The FDA’s CDER recently released draft guidance aimed at the development and recognition of voluntary consensus standards for pharmaceutical quality.

  10. How Will USPTO Guidance Revisions Impact Biosimilars?
    4/16/2019

    Since 2012, patent stakeholders in the U.S. have faced remarkable uncertainty in the evaluation of patent subject matter eligibility under 35 U.S.C. 101, particularly in the application of the Supreme Court’s Alice/Mayo1 test by the United States Patent and Trademark Office (USPTO).