GUEST COLUMNISTS

  • Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine
    Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine

    One of pharma’s greatest foibles as an industry has been the penchant to focus on the wrong things. We saw this with process analytical technology (PAT), where we focused on the design and implementation of the technology and ignored the impact of foundational material characterization and supplier control. Pharma 4.0 has the potential to fall into the same trap.

  • Do The Arguments For Pharmaceutical Price Increases Make Sense?
    Do The Arguments For Pharmaceutical Price Increases Make Sense?

    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.

  • FDA’s New Population Pharmacokinetics Guidance: What You Need To Know
    FDA’s New Population Pharmacokinetics Guidance: What You Need To Know

    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.

  • Breaking Down Amgen’s Win In The Biosimilar Enbrel Patent Fight
    Breaking Down Amgen’s Win In The Biosimilar Enbrel Patent Fight

    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.

  • FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis
    FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis

    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).

  • What Celgene Corp. v. Peter Means For Biosimilar Developers
    What Celgene Corp. v. Peter Means For Biosimilar Developers

    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).

  • Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”
    Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”

    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.

More From Our Guest Columnists

BIOSIMILAR WHITE PAPERS

  • Scaling A mAb Production Process To A Single-Use Platform
    Scaling A mAb Production Process To A Single-Use Platform

    The transfer of a monoclonal antibody production process between scales, often referred to as scale-up or scale-down, is a difficult task. This study reviews moving a monoclonal antibody production process from a microscale bioreactor to the Xcellerex XDR single-use platform.

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BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS

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Free collection of articles highlighting some of the dynamics playing out in the hospital setting for biosimilars, as well as how physicians and drugmakers can foster a greater understanding of biosimilar medicines.

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LIFE SCIENCE EVENTS

CRO Oversight Post ICH GCP E6 (R2) Addendum October 22 - 22, 2019
1pm-2:00pm EDT, Online Training
Writing Effective 483 and Warning Letter Responses October 23 - 23, 2019
1pm-2:30pm EDT, Online Training
GRx+Biosims 2019 November 4 - 6, 2019
North Bethesda, MD
Cleanroom Microbiology – A Foundational Introduction November 5 - 5, 2019
1pm-2:30pm EST, Online Training
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