Guest Columns

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Breaking Down Amgen’s Win In The Biosimilar Enbrel Patent Fight
    9/17/2019

    Following a trial in the District Court of New Jersey, Sandoz has been barred from marketing a biosimilar version of Amgen’s Enbrel product. Due to the scarcity of biologics patent case rulings, this case provides an interesting precedent for how future decisions may treat biologics patent issues.

  6. FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis
    9/16/2019

    This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).

  7. What Celgene Corp. v. Peter Means For Biosimilar Developers
    9/10/2019

    A recent decision by the U.S. Court of Appeals for the Federal Circuit has indicated that pharmaceutical makers with patent protection are unlikely to receive any compensation from the government for the loss of their patents during inter partes review (IPR) decisions by the Patent Trial and Appeal Board (PTAB).

  8. Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”
    9/4/2019

    With all the attention on the costs of pharmaceutical products, there is an upcoming regulatory “dead zone” that will potentially delay market entry of certain insulin products, adversely impacting insulin prices for consumers and payors. A recent Senate bill has been proposed to address this regulatory anomaly. Industry players should monitor this bill and other efforts to address the insulin dead zone, given how critical this product is to so many people.

  9. FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018
    9/4/2019

    In this two-part article, FDA supervisory consumer safety officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 program director Art Czabaniuk, and OPQO Division 3 investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. This part unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.

  10. 2 Bills, 1 Goal: Lower Drug Prices Through Biosimilars
    8/20/2019

    Just prior to an election season, it is not surprising to see a few bills emerge as potential silver bullets to solve pressing policy issues. One issue that has consumed the public for several years is drug prices. This article examines two Congressional bills aimed at increasing biosimilar utilization in an effort to lower drug costs.