Newsletter | September 14, 2023

09.14.23 -- Biosimilars Forum Statement On CMS Announcement Of Drug Negotiation List


Will You Sink, Survive, Or Thrive In This Biotech Market Correction?

Over the past 18 months, biotech has undergone a major transformation, down from the “sugar high” of the biotech bull market and steady flow of capital in the early pandemic years. Arda Ural of Ernst & Young provides key tips for your biotech to survive and thrive during the current market correction until investment in the sector cycles back to more prosperous times.

6 Ways To Achieve Manufacturing Audit And Inspection Readiness

Achieving audit readiness is not a snapshot in time but an ongoing commitment to maintaining day-to-day compliance and quality standards. Let's explore how your manufacturing and quality teams can align efforts with these six practices to maintain audit and inspection readiness at all times.

Agile Software Development In Biopharma And Medical Devices, Part 3

Computer software and systems validation testing is used to validate software under GxP environments. Parts 1 and 2 of this article series shared Agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration and change management, CAPA, and more.

Financial Leadership Of Strategic Procurement: 4 Foundational Steps

Efficiently managing a diverse supply base is crucial for drug companies to maintain growth, profitability, and compliance. While the procurement function can be organized under various executives, the relationship between the CFO, procurement, legal, and buying departments is very important.


Inspection Of Injectable Products For Visible Particulates

Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.

The Colloidal Particle Adsorption (CPA) Model In IEX

Learn about an adsorption isotherm class that is based on a colloidal description of proteins and achieves increased accuracy at high column loading in IEX modeling.


Humira Biosimilar To See $832M In Sales By 2029, Forecasts GlobalData

Biocon Biologics Continues To Expand Global Footprint, Completes Integration Of Viatris Biosimilars' Business In North America Ahead Of Schedule

Biosimilars Forum Statement On CMS Announcement Of Drug Negotiation List


Targeting The Fast Lane With Optimized Viral Detection


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