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Should we be worried about pharma’s supply chain?

World of DTC Marketing

A blood-thinning agent, heparin, had been adulterated due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs).

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California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form. This CMO will be responsible for product roll-out and distribution. In-house manufacturing the norm.

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European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. This looks like it may change shape in the future for the region, if the proposal put forward by the commission is adopted.

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Five Trends in Contract Drug Manufacturing Organisations

Pharmaceutical Technology

These companies often have limited in-house resources for product development or scale-up, and so depend on CDMO partnerships to achieve development milestones. As both a CDMO and a manager of CMOs, Avéma Pharma Solutions sees the following trends emerging to build the CDMO of the future. Narrower product focus.

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‘Right shoring’ API production in Europe

Pharmaceutical Technology

During the pandemic, the shortage of basic drugs such as paracetamol in key EU countries led to growing calls to push local drug manufacturing to ensure a smooth supply and to minimise shortages. Despite having large biopharmaceutical companies on home ground, the UK and France experienced major shortages and supply chain issues.