LSL Web-Exclusive Content

  1. Orphan Drug Commercial Models

    This article posits that the orphan market is actually a collection of seven distinct business model archetypes that are driven by key disease, patient, and market characteristics. By disaggregating and characterizing these business models and their key success factors/risks, readers may be able to focus their corporate strategies to optimize the value and impact of their orphan therapies.

  2. BioPharmaceutical Industry Reduces CNS Drug Development

    Only 12 therapeutics were approved for CNS indications between 2012 and 2016, as compared with 19 during the prior five-year period. Experts note that what is known about pathophysiology is more advanced in cancer than in CNS indications. The explanation for these developments differs across CNS indications. Here, we will focus on four CNS indications: AD, MDD, migraine, and schizophrenia.

  3. Biosimilar Discounting & Contracting: What Can The U.S. Learn From Europe?

    Based on our research, the European Union (EU) is 10 years ahead of the United States with respect to biosimilar adoption. It is therefore unsurprising that the EU’s actions and policy decisions are having an impact on the U.S. market. In this two-part series, we will consider multiple facets of the EU’s influence. Part 1 will focus on payer coverage of biosimilars and the role of discounting and contracting. Part 2 will highlight the effects of the NOR-SWITCH trial results and how the EU’s view of biosimilars as therapeutic alternatives, rather than generics, has influenced U.S. policy.

  4. How Biosimilar Companies, Employers Can Collaborate, Address Healthcare Challenges

    In addition to understanding what influences employers’ health plan decision-making, it’s important to note employers' growing demands for greater pricing transparency and the complexity posed by the lack of an integrated benefits system.

  5. Planned CDRH Reorganization Will Impact Device Approvals and Inspections

    The FDA Center for Devices and Radiological Health (CDRH) has proposed a reorganization that will collapse the Center’s seven offices into four, combining siloes of expertise into a new office that aligns talent into teams by product type and technology. Find out how this change may affect you. 

  6. The Biosimilar Patent Dance: What Can We Learn From Recent BPCIA Litigation?

    Of the 17 biosimilar products litigated under BPCIA to date, in most cases (about 70 percent), the applicants engaged in and completed the patent dance before the lawsuits (setting aside allegations of noncompliance with the disclosure requirements).  So far, in three instances, the biosimilar applicants have declined to dance outright.

  7. Industry 4.0: Improving Performance Of Pharma Manufacturing & Aseptic Processing

    Despite the challenges of maintaining an aseptic environment and producing a sterile drug product, I believed that someday science and technology would allow manufacturers to have the same level of confidence in aseptically processed products as they had in terminally sterilized products.

  8. 3 Keys To Successful Blockchain Adoption In Clinical Research

    Excitement around the potential for blockchain platforms continues to build. This parallels the surge in popularity of blockchain-based cryptocurrencies such as Bitcoin. Meanwhile, “critics argue it’s all hype — a technological hammer looking for a nail — and that the complexities of health information prevent practical use of blockchain technology.”

  9. Is Your Employee Struggling, Improving… Or Ready To Go?

    Are you dealing with a staff member who is not performing, behaving, or adding value as a leader? Here are five steps you should take:

  10. An Analysis Of Regulatory Reforms In China’s Pharmaceutical Market

    Over the past year, sweeping regulatory reforms have been introduced in China with the aim of encouraging innovation and reducing regulatory burden on the life sciences industry. The breadth of these reforms spreads across multiple stages of the drug development life cycle.