Wednesday, October 19, 2022 Daily Archives

Validation 4.0: An industry transformation

The life sciences industry is on the precipice of a new frontier — a future that is digital-first and technology-led. With the mass acceleration and adoption of software-as-a-service (SaaS) cloud systems—from discovery through to point of care—widespread digital transformation is a key business driver, saving companies critical time, resources, and spending. Despite this ongoing industry-wide shift, one business-critical aspect common to regulated companies lags: validation. Historically, compliance has followed the industry practice of Computer System Validation (CSV), which is paper-driven,…

J&J and Roche feeling the biosimilar bite in Q3

Both Johnson & Johnson and Roche are feeling pressure from biosimilars as sales of blockbuster products such as Remicade (infliximab) and Lucentis (ranibizumab) drop in Q3. J&J’s immunosuppressive monoclonal antibody Remicade has seen biosimilar competition in the US since 2016 when Pfizer’s Inflectra won approval. But while a series of pricing measures and a lack of challenge from interchangeable products have kept J&J from seeing a total sales wipe-out, the firm continues to see its infliximab revenues erode. For the…