Guest Columns

  1. Biologics Pricing: A Deep-Dive Into Dynamics And Behaviors Over Time 10/22/2019

    In this second part of a two-part series, we’ll dive into some of the details and datasets behind pharmaceutical pricing, trends, and behaviors in an effort to move toward effective cost management, economic sustainability, and continued U.S. pharmaceutical innovation.

  2. Trends To Watch In China’s Biopharma Industry 10/18/2019

    China’s biopharma segment has experienced double-digit growth for the past decade, and the landscape is poised for robust growth for the near future. The country's biopharma sales are on track to reach over $50 billion. Here's why that matters to you.

  3. Intro To Prefilled Syringe Selection: Staked-In Needles 10/15/2019

    This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts. 

  4. The Need For Enhanced Control Strategies In Biopharma Production 10/15/2019

    Biologicals are the next great step for the pharmaceutical industries. The double-edged sword is that, as the molecules become more and more complex, our need for control and understanding becomes greater. 

  5. Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook 10/8/2019

    At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but implications on the biosimilar market are yet to be determined.

  6. New Bill Aims To Drive Insulin Price Reductions 10/1/2019

    The Insulin Price Reduction Act (IPRA) proposes to drive price reductions by drug companies by providing them with incentives to roll back the list price of insulin products to 2006 levels. Specifically, IPRA would make it illegal for pharmacy benefit managers (PBMs) and insurers to recover rebates from manufacturers that reduce the prices they charge wholesalers for insulin to those 2006 levels.

  7. Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine 10/1/2019

    A race is being run to create the pharmaceutical manufacturing of the future and with Pharma 4.0, powerful market trends are shaping the running field.

  8. An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices 9/30/2019

    This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.

  9. Do The Arguments For Pharmaceutical Price Increases Make Sense? 9/24/2019

    This article will share recent analysis of price increases within the healthcare sector in an effort to understand the growth of healthcare expenditures and pharmaceutical prices over time.

  10. FDA’s New Population Pharmacokinetics Guidance: What You Need To Know 9/23/2019

    The FDA’s Population Pharmacokinetics Guidance for Industry draft calls for sponsors of new drug and biologics license applications to apply population PK analysis. This column covers the implications for drug and device manufacturers.