LSL Web-Exclusive Content

  1. Biologics Dose And API Outsourcing: A Decade of Decline?

    Can it be that today, when we expect increasing demand for CDMO services, biopharmaceutical companies have decided to outsource less of their commercial production needs than in the past? Some new data provided exclusively to Outsourced Pharma by PharmSource, an organization of GlobalData Plc., seems to suggest so. But if so, why that apparent trend reversal? 

  2. 4 Important Things To Consider Before Developing A Drug Delivery Device

    This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development.

  3. Merck’s Patient-Centric Approach To Trial Recruitment, Representation, And Retention

    Patient behaviors have changed drastically in recent years. With the widespread adoption of digital technologies, such as wearable devices that transmit patient data, and a surge in health-related information available online, patients have become more knowledgeable and engaged in the management of their own health than ever before.

  4. What Is the Current State Of BREXIT, And What Happens Next?

    The United Kingdom’s plan to leave the European Union now has PM Boris Johnson at the helm and (seemingly) a hard deadline of Oct. 31, 2019. Zaid Al-Nassir's breakdown for medtech leaders has been updated to include events taking place through Aug. 1, 2019.

  5. Nasdaq Listing Requirements Launch A Reverse Listings Revamp

    The SEC’s new changes to Nasdaq’s initial listing standards do have the potential to place substantial additional burdens on smaller companies seeking to list through reverse listings.

  6. 2019 U.S. State Policy Trends Impacting Pharma Manufacturers

    If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.

  7. Why CMO/CDMOs Should Seek Opportunities To Collaborate

    When I look at the state of the contract manufacturing and development industry, I see an industry ripe for disruption. It isn’t inconceivable to envision an outsider coming in to shake things up.

  8. How To Prepare For An FDA Inspection

    An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections and will generally result in inspectional observations.

  9. 3 Surefire Approaches To SOP Harmonization

    We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

  10. How 2 Recent Court Cases Could Impact Follow-On Biologics Strategy

    As follow-on biologics litigation expands, and the FDA provides additional information on the approval process for follow-on biologics, industry and observers are gaining clarity on how the Biologics Price Competition and Innovation Act (BPCIA) functions in practice. This article provides insight into two recent developments that will impact strategic and economic considerations for biologics developers.