Industry Insights

  1. Novartis’s Siponimod & Genentech’s Ocrevus: Challenges & Outlook For The Progressive MS Market 12/16/2016

    The first drug approval for primary-progressive multiple sclerosis (PPMS) may arrive by the end of March 2017, when the FDA is expected to render a decision regarding Genentech’s Ocrevus. Here, we will highlight recent positive data for Novartis’s siponimod in secondary-progressive MS (SPMS), explore key issues to watch as these medications enter the market, and look ahead at the commercial opportunity in progressive MS.

  2. The LAL Assay for Pyrogen Testing Of Parenteral Products: Evolution & Challenges 1/27/2017

    The United States Pharmacopeia (USP) harmonized Chapter <85> Bacterial Endotoxins Test describes the procedures for performing Limulus amebocyte lysate (LAL) assays for the detection of endotoxins in pharmaceutical products. This article reviews the development and evolution of the LAL assay, its uses, and misunderstandings that have occurred.

  3. An Intro To Adverse Event Reporting And Product Complaints 4/23/2019

    Managing complaints and controlling adverse events are critical tasks for a pharmaceutical company. While varying international regulations for adverse event reporting and product complaint handling make it difficult to automate processes and implement SOPs, it is necessary for companies to successfully resolve incidents and continue on a path to innovation.

  4. 4 Important Things To Consider Before Developing A Drug Delivery Device 8/6/2019

    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. In this installment, we will look at the areas of primary container, device development, device selection, and design control.

  5. The CAPA Detective 9/16/2015

    Every industry has its detectives.  Mechanics and journalists hunt for leaks.  Software testers and security experts look for bugs.  Meteorologists, defense strategists, and forensic accountants all look for trouble brewing off shore.  The level of intrigue may vary.

  6. Are You Properly Selecting Your CMO Partners? 8/4/2014

    At the 2013 WTG Global Pharma Manufacturing Summit in Boston, Angie Green gave a presentation on the steps sponsors should follow when selecting CMO partners. The CMO selection steps Angie reviewed are echoed in many of the conference sessions for Outsourced Pharma West—topics chosen by Life Science Leader readers.

  7. 5 GCP Compliance Mistakes To Avoid With Job Descriptions, CVs, & Org Charts 9/11/2018

    When it comes to GCP audits and inspections, low-hanging fruit says a lot about the tree.

  8. UPDATED: New EMA Requirements On Nitrosamines — What ALL Pharma Companies Need To Know 1/7/2020

    The EMA recently issued two new publications containing information on nitrosamines for marketing authorisation holders (MAHs). Every MAH and manufacturer of chemically synthesized APIs and resulting drug products should carefully read the new EMA expectations on potential nitrosamine contamination.

  9. How Biosimilar Companies Can Survive An Uncertain Future 8/31/2017

    In this final installment of a three-part series, managing directors Jonathan Kfoury and Ricardo Brau of L.E.K. Consulting share their perspectives on six biosimilar company archetypes, emerging biosimilar development and business strategies (as well as mistakes to avoid), and the market’s future.

  10. The Unsung Powers Of Moderation In Business 7/23/2015

    We live in a society that worships the new, the radical and the fast; yet we live on a planet that overwhelmingly favors a moderate pace to win the race. Can both be right?