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How to start up an ATMP clinical trial

7 July 2020 | By

Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues or cells. They offer revolutionary opportunities for the treatment of disease and injury; however, developers face a complex regulatory and developmental landscape to bring ATMPs to market. Here Magdalena Czarnecka offers guidance and advice on effectively initiating an ATMP…

Comparison of new vaccine approaches – COVID-19

26 June 2020 | By

The promise of virally vectored DNA and mRNA vaccines is tremendous in terms of vaccine safety and speed of response to new pathogens. This article explores why these approaches have attracted attention in light of the COVID-19 pandemic and why they are highly appropriate for rapid vaccine development and deployment.

Five patent issues that European biosimilar developers should consider before entering the US market

26 June 2020 | By , ,

As patents on originator biologic medicines begin to expire, there are growing opportunities for biosimilars to enter the market at lower prices. Joshua Whitehill, Natasha Daughtrey and Grace Truong discuss key aspects of US patent law that European developers should consider before entering the American market.

The circuit of life: saving on manufacturing, waste and delivery-related supply chain inefficiencies

26 June 2020 | By ,

Many pharmaceutical companies have complicated supply chains that are inefficient and ill-equipped to deal with current demands. This article explores how digitalising the healthcare supply chain can address the pharmaceutical sector's increasing financial-, capacity- and waste-related strains associated with our ageing population and the soaring costs of new treatments.

How implantable systems and microparticle depot injections are meeting the needs of long-acting drug delivery

26 June 2020 | By ,

Implantable systems and microparticle depots are used in many areas of drug delivery to release medicines at a controlled rate within the body. The use of these long-acting dosage forms eliminates the need for frequent administrations via traditional routes of administration, which ensures patient compliance and results in improved outcomes.…